Dietary Guidelines Advisory Committee

Third Meeting

June 16-18, 1999
1800 M Street, NW, Washington, DC


In the Matter of:

Dietary Guidelines Advisory Committee Meeting Transcript

Thursday, June 17, 1999

Economic Research Service
1800 M Street, N.W.
Waugh Auditorium
Washington, D.C.

Pages: 318 through 581

HERITAGE REPORTING CORPORATION
Official Reporters
1220 L. Street, NW, Suite 600
Washington, D.C.
(202) 628-4888

The hearing in the above-entitled matter was convened, pursuant to Notice, at 9:03 a.m.

IN ATTENDANCE

CUTBERTO GARZA, M.D., Ph.D.
Vice Provost and Professor, Cornell University
Associate Director, Food and Nutrition
Programme, United Nations University

RICHARD J. DECKELBAUM, M.D.
Director, Institute of Human Nutrition
Columbia University College of Physicians and Surgeons

JOHANNA T. DWYER, D.Sc., R.D.
Director, Frances Stern Nutrition Center
New England Medical Center
Professor of Medicine (Nutrition) and Community Health
Tafts University School of Nutrition

SCOTT M. GRUNDY, M.D., Ph.D.
Chair, Department of Clinical Nutrition
Director, Center for Human Nutrition
University of Texas Southwestern Medical
Center at Dallas

RACHEL K. JOHNSON, Ph.D., M.P.H., R.D.
Interim Associate Dean, College of Agriculture and Life Sciences
Associate Professor Nutrition and Food Sciences
University of Vermont

SHIRIKI K. KUMANYIKA, Ph.D., M.P.H., R.D.
Associate Dean for Health Promotion and Disease Prevention
University of Pennsylvania School of Medicine
Center for Cinial Epidemiology and Biostatistics

ALICE H. LICHTENSTEIN, D.Sc.
Professor, Tufts University School of Nutrition Science and Policy
Senior Scientist
Jean Mayer USDA Human Nutrition Research Center on Aging
Tufts University

SUZANNE P. MURPHY, Ph.D., R.D.
Researcher, Cancer Research Center of Hawaii
University of Hawaii

MEIR J. STAMPFER, M.D., Dr. P.H.
Professor of Epidemiology and Nutrition
Harvard School of Public Health
Associate Professor of Medicine
Harvard Medical School

LESLEY FELS TINKER, Ph.D., R.D.
Assistant Member, Fred Hutchinson Cancer Research Center
Affiliate Assistant Professor
Department of Health Sciences
University of Washington

ROLAND L. WEINSIER, M.D., Dr. P.H.
Chair and Professor, Department of Nutrition Sciences and Medicine
School of Medicine
University of Alabama at Birmingham

DR. XAVIER PI-SUYNER
Columbia University

DR. CLAUDE BOCHARD
Director, Pennington Center

EILEEN KENNEDY

SHANTHY BOWMAN

CAROLE DAVIS

ALYSON ESCOBAR

JOAN LYON

KATHRYN McMURRY

LINDA MEYERS

CAROL SUITOR


P R O C E E D I N G S

DR. GARZA: Yesterday, we heard from Dr. Ludwig on the glycemic index and health disease relationships and out of a concern that there are certainly more than one viewpoint on this issue, we tried to find representatives that might give us a good view of the spectrum. So, we are very lucky that Dr. Xavier Pi-Suyner agreed to come, with much prodding, from a very busy schedule. We're very pleased that he made some time to join us this morning.

So, without my taking any further time, Dr. Suyner is from Columbia University, extremely well known researcher in the area of diabetes, obesity, energy metabolism. Thank you very much for joining us.

DR. PI-SUYNER: Well, it's a pleasure for me to be here and speak with you about the question of carbohydrate and glycemic index. There's been a lot of debate over this subject over the years, and I think it's been primarily directed at the diabetic population. But, what you're talking about here is directing it to the population at large, and I think that brings up some issues that I would like to discuss.

I'm sorry for my overheads, but I was travelling and I didn't have a chance to copy them. But, what I'm going to talk about today first is a diet with high glycemic-index food detrimental to health? And, is a diet high in carbohydrate detrimental to health?

And, the most often described health risks with regard to both of these topics have been obesity, diabetes mellitus, dyslipidemia, primarily, and hypertriglycidemia. I'm uncertain, scattered reports of cancer, particularly of colon cancer, lung and breast. Now, I'm not going to deal with the cancer issue, because I think there isn't really enough data to deal with that, and I don't think it's relevant to your discussions at the present time, given the paucity of information.

I want to start with the second point first, namely, is a diet high in carbohydrate detrimental to health? And, I'm going to spend very little time on that and go on to the glycemic index. I think my reading of the literature is that there is no convincing data that a high-carbohydrate is detrimental to health. If you look at the epidemiological studies over the years, if you look at traditional studies in traditional societies, the Japanese, the Chinese, the Mexicans, many others, East Indians, they generally were eating a low-fat diet, high carbohydrate, and low calorie, and their incidence of diabetes mellitus and of cardiovascular disease was really much lower than Western countries.

When you go to transitional societies that are moving from the traditional to the more Western society, we've had really quite a lot of studies over the years. We've had studies of the Japanese, of the Chinese, of the Mexicans and of the East Indians. The East Indian data mostly from the United Kingdom, and in all of those societies, they're moving to a higher fat, lower carbohydrate, higher calorie diet, which, with an increased incidence of both diabetes and cardiovascular disease.

Now, there's a confounder here between higher fat and higher calories, so that one can't ascribe it all to fat. Much of it has to do with a higher caloric content of the diet.

And, then, finally, the highest incidence of diabetes and cardiovascular diseases in Western countries with a higher fat and lower carbohydrate and higher calorie diet. But, essentially, the lower caloric intake of most traditional societies worked against the appearance of diabetes and cardiovascular disease.

Now, aside from these isolated studies, there are also quite a number of comparative international studies, that is, studies done by one group or individuals across the spectrum. There have been the studies in Japan and Japanese-Americans in Hawaii and the Japanese-Americans in the United States that show that as carbohydrate is decreased and fat is increased, the risk of diabetes and cardiovascular disease goes up, and it's highest in the U.S.-Japanese.

Now, again, this is confounded to some extent by increasing caloric intake and increasing body weight. In Mexicans, the San Antonio group at the University of Texas, Steve Haffner and his group, have done studies in Mexico, retrospectively, and then in Mexico now, and in Texas now, similar genetic pools, showing that with increasing fat and decreasing carbohydrate and increasing calories, again, we get a much higher incidence of diabetes and cardiovascular disease.

So, I see no data in the epidemiological literature to suggest that taking a high carbohydrate diet is detrimental to health. Now, taking a high caloric balanced diet may be detrimental to health, but that is across the board in terms of calories and not focusing on carbohydrates.

Now, I want to move onto the glycemic index and the first thing I'd like to do is just to define the glycemic index for you in case you don't remember it. The glycemic index really deals with a meal test. A meal test is to compare 75 grams of glucose with 75 grams of any food that you're trying to test, and you're testing the food as a pure food, as that single item of food.

What you then do is do essentially a tolerance test and follow the glucose over time, over a period of two hours, and the glycemic index is the curve of the food over the curve of glucose times 100, okay. So, you take whatever curve you get for glucose, whatever curve you get for the food, you put one on top of the other, and then you multiply by 100. It's a percentage of the response you get from glucose.

Now, there's been a lot of argument over the years about whether the glycemic index should be measured as the area under the curve from the fasting, which is what I've shaded here, or the whole area under the curve. And, I can tell you, volumes have bee written about which way this should be done. The proponents of the glycemic index as something that is kind of pathological and you have to worry about, have argued that you should take the area above the fasting level, the difference between this and this. Other proponents have argued that insulin is insulin, and you can't detect this molecule from this molecule, and that the area under the curve is what is important when you calculate the glycemic index.

This makes a big difference because we're talking about very small statistical differences between one glycemic index food and another, okay, and if you're going from a glycemic index of 65 to a glycemic index of 70, you may find a difference statistically if you do the area above the curve, but you may not find it if you do the whole thing. So, there's a confusion right from the start as to what the glycemic index really is and how you define it. And, there are proponents to the idea that it should be the area above the curve. There are proponents to the idea that it should be all of the insulin, since all the insulin is the same and all the insulin is circulating and why make an arbitrary decision by the amount of insulin that comes out after a meal?

Now, just to give you some example, I've put here a glycemic index of some foods. You can see that white bread is 100. That means that the glycemic index of white bread is exactly the same as that of glucose. Dark bread varies very widely, 58 to actually 100. Mashed potatoes, 104. If you don't mash the potatoes, it's much less, goes down into the 70s. Cold breakfast cereal can vary anywhere from 72 to 127. The cola beverage is around 87, apples, 65, orange juice, 65, yogurt 35, broccoli, 45, peanut butter, 40. Chocolate is also very low, but peanut butter and chocolate, as you know, have a significant amount of fat.

The point I want to make with this slide is that there are foods, and I'll come back to that, where there's a very wide variation between different foods and the way they're processed, the way they're cooked, with regard to the glycemic index. The more processed the food, the more disrupted you say, the less natural the food, generally the higher the glycemic index.

The more unobstructed the food, the less cooked the food, generally, the lower the glycemic index. Now, if you'd talk about high and low glycemic index effect, the individuals who proposed the glycemic index hypothesis on health suggest that with a low glycemic index, you would have a lowered glucose response. As a result, you will have a lower insulin response. You will have less suppression of free fatty acids, so your FAA will be elevated, will be more elevated.

As your glycemic index increases, you're going to have most higher post-prandial glucose. As a result, you'll require more insulin and you'll suppress fatty acids more distinctively. Now, the carbohydrate insulin hypothesis thing goes that with increased insulin that you get from the high glycemic index foods, you're going to have an increased food intake. In other words, it will drive the hypothalamus to make you hungry, you will eat more, and you're more prone to obesity.

The other hypothesis which has been proposed by the group at Harvard, the Nutrition Department, is that the high insulin would lead to beta cell exhaustion over time, because of the greater insulin demand, and that would lead to diabetes.

And, the third that is proposed by some, is that the increased insulin leads to an insulin resistant state, which then can lead to diabetes and cardiovascular disease.

Now, you probably heard yesterday from Dr. Ludwig, who is a proponent of this theory, the arguments for, and so what I would like to do is to give you some arguments essentially against this hypothesis. Now, the first study I want to show you is a study that was published by Keens and Richter in Scandinavia, in Denmark, I believe, in which they tested high glycemic and low glycemic index diets in individuals. And, the reason I'm showing you this amongst the many, many studies that are done is that I think it's a mistake to look at this question of glycemic index in terms of a single meal.

Most of the data dealing with increased food intake with high glycemic index deals either with a single meal, where you give a high glycemic index meal or a low glycemic index meal, and then you follow food intake over a period of time. Or, like Dr. Ludwig did it, he did two meals, breakfast and lunch and then went for five hours after lunch.

Now, whereas I have no problem with the design of that experiment as an experiment, I think what we're really talking about when we talk about giving recommendations to a population, what we want to talk about is the long-term effect. Now, there are very few -- if you go through the literature, there are almost no long-term effects, long-term studies of high glycemic index versus low glycemic index in the literature. They are rather low.

But, I found this one. This is done by a group in, as I said, in Europe, and they provided food to these individuals for 30 days. This was published in the American Journal of Clinical Nutrition in 1996. And, what I show you here is -- first of all, I'll show you the glucose. Before and after 30 days, you'll see here the dotted line is the low glycemic index, the solid line is the high glycemic index. This is a 20-hour test. After 30 days on a high glycemic and a low glycemic index diet, that was carefully monitored, and you can see here the high glycemic index, the low glycemic index, and this is the average standard area, the mean, and there's absolutely no significant difference, no difference after 30 days on a high glycemic index diet and a low glycemic index diet.

Here is the results of the insulin. Again, the solid is the high glycemic index. The dotted is the low glycemic index. No difference across here in terms of the insulin values before and after, and you'll notice importantly that the fasting values are not different, either. There's been some talk about insulin resistance with a high glycemic index diet. If you expect a lean normal individuals in insulin resistant state, after 30 days, you would expect a higher fasting insulin level responding to the insulin resistant state.

Now, these individuals, investigators not only did glucose and insulin, but they did hyperglycemic, glycemic hyperinsulinanemic clamps on these individuals. And, so, before the end of 30 days, at the end of 30 days, they did clamps. You notice here that the glucose uptake, this M stands for the glucose uptake, the whole body glucose uptake on a clamp in these young men were equivalent. In other words, there was no increased insulin resistance at a physiological level of insulin, 370 pica amounts per liter, between the high glycemic index and the low glycemic index individuals.

The glucose was not different, the insulin was not different. There was some increased triglycerides in the high glycemic index, and there were lower free fatty acids in this group.

Now, there are other studies that are somewhat similar to these, but they're not as focused and not as long, that tend to suggest that over time, if there is a temporary increase in insulin, short-term, in a one-meal set up over a longer time, this is not borne out.

Now, I want to go to epidemiological studies from here and review the two studies that I think have been seminole in getting people to think that maybe high glycemic index is detrimental to health, leads to diabetes and we should do something about it in our population. And, they're the two studies by Salmeron and the epidemiological group at Harvard. And, I'd like to go through them a little carefully, because I think that they're important to your deliberations.

Now, the first study was the Salmeron study that was published in the JAMA in 1997, Volume 277, page 472, and it reported on 65,173 U.S. women. Now, these are not ordinary women. They are health professionals, okay, so they're not representative of the population as a whole. They are nurses, Ph.D.'s, medical workers of one kind or another.

They were followed for six years. They were given a semi-quantitative food frequency questionnaire, which consisted of 131 items. Over a period of six years, until the time of this report, 915 of them became diabetic. That is, 1.5 percent of the sample, or .25 percent per year became diabetic.

The second report was in diabetes care. Again, 1997 -- that's not a seven, that's a nine -- and 42,759 men, six years, 523 diabetic patients over the six years, 1.2 percent conversion rate, .2 percent per year, and again, semi-quantitative food frequency questionnaire.

Now, let me just describe for you this questionnaire. The questionnaire was a questionnaire that, as it says, had 131 items. It was mailed to the individuals. The individuals responded on their own. They put down what they had eaten on a -- and they also had to have some element, I assume, of the portion sizes that they were eating. There was no direct interview between the person who was collecting the data and the individuals who were filling out the questionnaire. Okay, they did it at home. It was mailed to them and they mailed it back.

Now, in the text of the original article, it says, "A full description of the food frequency questionnaire in its abbreviated form, 61 items, and of the procedures for calculation of nutrient intake, as well as data on reproducibility and validity in this cohort have been previously reported."

Okay, they reported that validity, a questionnaire that had 61 items -- this questionnaire had 131 items. The second thing is that they accepted questionnaires that had less than 60 blanks. In other words, you could have -- they have to fill at least 70 blanks out of 131. So, essentially, you could fill out half the questionnaire and be considered part of this study.

Okay, my problem with this kind of questionnaire is not that this isn't worth doing, but that it's a very inaccurate way of measuring food intake in individuals, okay. You're asking people to do this independently, you're giving them a questionnaire, they're filling it out at home. You have no real idea about their ability to measure portion sizes and you're going to calculate total carbohydrates and then total individual items in that carbohydrate meal. And, so, you're depending on them being extraordinarily good reporters of what they're eating.

Now, we know from other data unrelated to this article that getting accurate dietary information out of people is extraordinarily difficult. It gets more difficult as people get fatter and we know that Americans are getting fatter. And, that the inaccuracy as BMI increases, so that I personally don't have a lot of faith in the very small numbers that we're dealing with, as you'll see when we get to the conclusions from these reports.

Now, to start off with, I just want you to note some things that came out of this study, these two studies. First of all, sugar is never mentioned in either of the studies. Now, we're talking about two big articles on carbohydrates and sugar is never mentioned, okay. It's not mentioned because there was no significant effect of sugar.

Total carbohydrate, there was no significant effect. When you get to the glycemic index score and the glycemic load score, which I will come back to, the glycemic index score was significant in women but it was not significant in the men. The glycemic load score was not significant in either the men or the women and it only became significant after adjustment for cereal fiber intake, okay. In other words, they did not get an effect from the glycemic index, then they added in a second component and said, well, what if we add cereal fiber to that, and when they added cereal fiber to that, they got an effect.

So, we've got three non-significants and only one significant. Now, let me tell you how they calculated this, because I think it's important for you to understand this. They used what is called the average dietary glycemic index, which comes from Wolever and his group, Jenkins, the group in Toronto. It's published in the American Journal of Clinical Nutrition in 1994. And, the way this calculation works is, you take the carbohydrate content of each food from the USDA Handbook, you multiply by the number of servings per day and then you multiply by the glycemic index. Then you take the whole thing and you divide it by the total carbohydrate intake for that day.

So, you have the carbohydrate content times the servings per day times the glycemic index over the total carbohydrate, and you get the average dietary glycemic index.

Now, this is a USDA meeting and I don't want to be disrespectful, but we recently put a bagel in a bomb calorimeter and compared what we got to what is in the USDA Handbook, and our bagel was two and a half times, had two and a half times as much calories as was in the USDA Handbook. Now, I'm not saying this to criticize --

DR. GRUNDY: Was that a New York bagel?

DR. PI-SUYNER: That's a New York bagel.

(Laughter.)

DR. GRUNDY: Well, that's not fair.

DR. PI-SUYNER: Now, I'm not saying this to criticize the USDA. I'm saying it that we're talking about a rather inaccurate calculation. You take it from the USDA Handbook and there's a lot of variety between foods, variety in geographical areas, variety between countries, etc.

Then you take the number of servings per day of that particular food, which is dependent on the recall of the individual that you've sent the questionnaire to, and then you multiply it by another inaccurate number, the glycemic index, which is also variable from test to test.

So, you know, white bread is not always 100 when you test it. Sometimes it's 110 and sometimes it's 90. So, you've got a variation around the glycemic index. So, we're essentially multiplying four, three very inaccurate determinations and dividing it by a fourth inaccurate determination, and we come up with a number.

The second thing that they used besides the glycemic index is the global dietary glycemic load, and that's the carbohydrate content times the servings per day times the gastric, the glycemic index, without dividing it by the total carbohydrate. And, that, they used as they state, as a measure of insulin demand.

So, again, quoting from their paper, "The glycemic index as a relative measure of glycemic response to a given amount of carbohydrate, does represent the quality of carbohydrate, but does not take into account the quantity." And, then, "In contrast, the total glycemic load represents the combination of quality as well as quantity of carbohydrates consumed, and may be interpreted as a measure of insulin demand."

So, what they're saying is that this is quality, this is quantity and this may be more related to the insulin demand, because it gives the total amount, the total load, you might say.

Now, I want to show you their results. We take first the men, and this is the glycemic index and this is the glycemic load, divided by quintals. Okay, this is the relative risk, using the lowest quintal as one, and you can see these are 95 percent confidence intervals. You can see here that the confidence interval here is .86 to 1.5, .85 to 1.5, .86 to 1.5, .96 to 1.62, P value not significant at .12.

Glycemic load, .8 to 1.36, .73 to 1.28, .75 to 1.36, .77 to 1.43, P value .83 not significant for trend. Okay, so we got nothing in the men. Here's the women.

Glycemic index, we get a significant value of .04. You can see the confidence intervals, though, .92 to 1.45, 103 to 161, 102 to 159, 125 to 154, very close to non-significance. And, the glycemic load is non-significant at .09. Okay, so the glycemic load which they, themselves, quote as being the important item for insulin demand is not significant in both men and women.

Now, I'd like to go on now and talk a little bit about the practicalities of telling a population that they should not have a high glycemic foods and they should have low glycemic foods. My first item here is foods in the questionnaire contributing most to carbohydrate variation in our cohort. This is, again, from the Salmeron study. Okay, these are the foods that they list as being most important contributing to carbohydrate variation. Cooked potatoes, french fried potatoes, cola beverages, jams, pasta, white bread, English muffins, white rice, cold breakfast cereals.

Now, I already showed you that cold breakfast cereals have a very wide variation, okay, in glycemic index. They can go from the 60s all the way to the 120s, 110s. We know that rice has wide variation, according to the kind of rice, the way it's processed, how much amylose is in it, etc. We know that potatoes, there's a big difference how they're cooked and also whether they're mashed or not or whole, and I'm just interested in knowing whether the recommendation of the dietary guidelines would tell people not to eat potatoes and not to eat rice, certainly, and possibly not to eat breads when these are staples of a carbohydrate intake.

And, please remember that it's not just white bread, but also whole wheat bread has a high glycemic index. There's also another complication for populations trying to figure out a high glycemic index and that is that many diverse common foods have similar GI values. Now, here's a whole group of foods that I've picked out for you have a high value range, 94 to 106. You know, they don't have a lot of relationship -- Melba toast, bagels, white bread, 100 percent whole wheat bread, angel food cake, graham crackers, whole wheat crackers, cous cous, corn chips, oatmeal muffins, french fries, mashed potatoes, canned green pea soup, breakfast cereals, such as Cream of Wheat, Cheerios, Golden Grahams.

So, as you tell the population to change to a lower glycemic index diet, you're going to have a lot of confusion about the food items that are included or not included. Another way to put it here is, I've put on your left high GI foods and the right, low GI foods. Bread, you'd have to tell them that they have to take bread that contains a lot of whole grains. Processed breakfast cereals versus unrefined cereal, oats, muesli or porridge. Also, some processed materials which have a low GI factor that have been put in, such as Kellogg's All-Bran, that has extra fiber. Plain cookies or crackers, you'd have to tell them to have cookies with dried fruit and whole grains. Same with cakes and muffins.

Tropical fruits such as bananas are high glycemic index, so are you going to cut out bananas? And, temperature climate fruits are better, namely things like apples. Potatoes are high and pasta is lower, but are you going to cut out potatoes? Rice is generally high, but there are kinds of rice like Batsmati rice and other high amylose rice which are low, and so, are you going to define for people the kind of rice that they're going to eat?

Now, the other thing that happens is the GI values of some foods can vary widely. And, that, you notice you can take the same food and the glycemic index can vary, depending on the variety, the processing and the preparation.

As I mentioned, there are many varieties of rice with different types of starch, processed in different ways, that result in a very variable value of glycemic index. As an example, the glycemic index of one-inch cubes of boiled potato can be increased 25 percent by mashing them. Just by mashing these one-inch cubes, you can increase the glycemic index by 25 percent. So, are you going to tell people not to mash their potatoes?

And, there are subtle differences in some fruit. For instance, in bananas, according to the ripeness, you can double the glycemic index of a banana, just by how ripe that banana is or is not. So, are you going to tell the population how ripe of a banana they should eat in their dietary guidelines?

I'm pointing this out to just remind you how difficult this is going to be for the individual citizens who you're giving the recommendations to. Now, I put this on as an exercise of what's going on with the glycemic index, okay? This is taken from a paper by a very respected food technologist, Chatrevette, and he tested different starches in India. And, he writes at the end of his paper, "The glycemic index of grain amaranth, wheat and rice preparation was studied in non-insulin dependent diabetic subjects. Diets containing 50 grams carbohydrate equivalent were given and post-prandial blood glucose estimated at different intervals of glycemic index, calculated for different experimental diets, showed that the glycemic index of amaranth wheat composite flour, 25 to 75, was the least, 65.5 percent, followed by the wheat diet, 65.7 percent, the rice diet, 69.2 percent, the amaranth wheat diet, 50/50, 75.5 percent and popped amaranth in milk, 97.3 percent. Therefore, a 25/75 combination of amaranth and wheat, wheat and rice, can be considered low GI food, 50/50 grain amaranths in wheat medium GI food, and popped amaranth in milk combination, high GI food." Now, tell that to your citizens.

What I'm saying is, first of all, this fellow did not find that the rice that they're using is any worse than the wheat. In fact, you can see here, he got rice 69.2 and the wheat, 65.7. And, in the 50/25/75/65.5. So, when you get into the question of how individuals are going to construct their diet and you try to tell them what is high glycemic index and what is low glycemic index and what starches they can use and what starches they can't, you're going to have problems.

Now, to bolster that argument, I'm going to give you a quote from Wolever himself, who is the champion of high glycemic index diet -- low glycemic index diet. "Being on a low glycemic index diet does not require elimination of all high glycemic index foods. Indeed, there are situations where high glycemic index foods may be appropriate or even desirable." So, you're going to tell your citizens, don't have high glycemic index foods, but if you want some, it's okay and may even be desirable for you to have some.

Now, I quote you another quote from Wolever, because it makes the point about short-term studies. He says in one of his articles, "Glycemic responses are quite variable from day to day within subjects." Okay, this is the champion of low glycemic index foods. "Glycemic responses are quite variable from day to day within subjects. Thus, when the number of subjects studied is not large and the expected difference is small, there is a large possibility of not detecting a difference that really exists, Type II error." Okay, these differences are so small that he's worried that half the time you're not going to be able to pick them out, okay, you're not going to find a difference.

He goes on to say in the same article, "If a significant difference is not observed, the responses are considered to be the same. This is an inappropriate approach because the fact that no difference is detected does not necessarily mean that no difference really exists." Okay, so he's saying, even if you don't get a difference, there's a difference there. You just aren't picking it up.

Well, if the difference is so small that in repeated tests, it can't be picked up, it can't be made, it's not even statistically significant, not to say clinically significant, then I think we have a problem recommending that to the American people.

So, I want to finish up with this quote, which is from Gerry Reaven. "The results of epidemiological studies provide hypothesis to be tested, not definitive answers to biological questions." And, I think that's where we are today. We have hypotheses to be tested, but we don't have definitive answers to this biological question.

I can tell you that the Diabetes Association has been struggling with this question for years now and has never come up with the idea that they should recommend a particular glycemic index for diabetic individuals, and the reason they have not is two-fold. Number one, the long-term data is essentially non-existent, and the difficulties of providing a clear message to the diabetic individuals about what he or she cannot eat and the caution, the worry that we would be eliminating foods from the diet that are absolutely good foods, for no particular reasons.

For instance, you know, take the minority population, the Hispanic population in America, which eats a lot of rice, okay. Are we going to take away rice from the Hispanic population from America and tell them they all have to switch to potatoes with the kind of data we've got? I think it would be an enormous mistake to do that. Maybe in the future, we would have more data to base the public health recommendation of this sort on, but I think at the present time, given the data that we have, which I think is considerably flawed, I would not recommend that you recommend that the glycemic index suggestion on the dietary guidelines.

I think there already are in the guidelines recommendations for having a high fiber diet. I have to tell you that in the Salmeron study, the only fiber that was significant in terms of the diabetes was cereal fiber. Soluble fiber was not significant, made no difference. The difference in the women, between the high cereal fiber and the low cereal fiber was something, I think it was 2.4 grams a day. So, how an individual is going to switch by 2.4 grams a day, I'm not sure. But, I think giving a recommendation of high fiber would be a good thing to do, maybe more for the GI effects than for the effect it might have on diabetes and lipids.

So, with that, I'll stop. I think I've gone over. I'll be happy to answer any questions you may have.

DR. GARZA: Okay, thank you very much. Are there any questions? Roland?

DR. WEINSIER I think I know the answer, but just to have it on record, unless there's a third choice you can think of, if you had the choice as a recommendation to us, would you suggest we address the issue, but downplay, we don't address the issue, ask for more research or await more research?

DR. PI-SUYNER: I would not address the issue. I think the average citizen is not going to know what you're talking about if you talk about high glycemic index. And, unless you actually are going out to make a recommendation, I don't see any point in doing it.

You will have addressed the issue of fiber, I assume, and that takes care of a good bit of that, because the higher fiber foods, generally, are lower glycemic index. So, you already, in effect, have a recommendation for a lower glycemic index diet, by putting in a fiber recommendation. Although, as I mentioned to you, in the studies, the Salmeron studies, dietary fiber, soluble fiber was not significantly affected. Yes?

DR. DWYER: Xavier, in very, very high carbohydrate diets, take very high rice diets, where it's a staple and people are eating a lot, like 55, 60 percent, just from one staple, refined cereal, what is your view on utility of these concepts there?

DR. PI-SUYNER: Well, see, I think what's happening is people are confusing glycemic index with excess calories. I mean, people have been taking that kind of diet in Japan for centuries without any problem, you know, no high incidence of heart disease or diabetes. All right, so it's not a question of having a very high carbohydrate diet, it's a question of having a lot of carbohydrate calories.

All right, what you're doing is, you're overeating. Now, you can take the same glycemic index food and if instead of taking 75 grams of it, you take 150 grams of it, you're going to get a much greater insulin response. Same glycemic index food. Okay, you'll get triple or four times the response of insulin if you take double -- instead of 75 grams, you take 150 grams.

So, it's not a question so much of taking carbohydrates, it's a question of taking too much of everything, including carbohydrate. So, I think the message to the population would be better being to limit your calories than to limit your carbohydrates. And, certainly, within the carbohydrates, as I mentioned, total carbohydrate was not significant in the Salmeron study. Sugar was not significant. We're left with a small portion of the whole, the total carbohydrate intake.

DR. GARZA: Scott?

DR. GRUNDY: Two questions. Would this, would you extend this to sugars, as well, on the glycemic index? Would you think it should be a recommendation?

DR. PI-SUYNER: Well, you know, sugar is a low glycemic index food, it's not a high glycemic index food, because it has fructose, that's 50 percent of its carbohydrates. So, when you test it, sucrose is lower than glucose by quite a bit.

DR. GRUNDY: Is there any reason to moderate sugar intake, then, on the glycemic basis?

DR. PI-SUYNER: Not on the glycemic basis. There's other reasons, which you've heard about, you know. So-called empty calories and the fact that you're getting no vitamins and minerals when you're eating the sugar and so forth. So, personally, I think 18 percent sugar intake is very high in this country and it contributes very significantly to the caloric load that we're eating. So, I personally thing for other reasons, cutting back on sugar is probably a good thing, but not from a glycemic index approach, since it's a low glycemic index food.

DR. GRUNDY: Okay, second question was, you through up that one hypothesis about the insulin exhaustion theory from overstimulation, whether it be from excess calories or whatever it's from. Do you think that's a valid hypothesis, or what's your view on that?

DR. PI-SUYNER: Well, I think insulin demand as a stimulus to the bringing on of diabetes is a perfectly valid hypothesis. I think you have to have the right genes, you know. We have obese people who are 500 pounds that have been 500 pounds for ten years, that are non-diabetic, because they don't have the diabetic gene, so you have to have gotten the appropriate gene that will cause a defect in the beta cell. The beta cell will eventually exhaust.

But, if you have those genes, yes, I think the insulin demand theory is a reasonable theory, but we don't have any long-term testing of it as a hypothesis. And, the beta cell is actually, as we see from these very obese individuals, is able to manufacture lots of insulin over time. So, generally, I think it has to be an interaction between the environment and the genetic predisposition to get this.

The question is, how much insulin demand is enough to cause the problem? And, you know, when you're talking about a different -- I have to tell you, I was trying to find the -- the difference between the first quintal and the last quintal in that Salmeron study, I think the first quintal was a glycemic index of 64 and the last quintal was 71, okay. So, I have that in -- I think it was seven points, 64 to 71.

Now, to get to that kind of shaving, of moving somebody from 71 to 64, you know.

DR. GARZA: Yes, Shiriki?

DR. KUMANYIKA: Does your comment about over-consumption of foods at one occasion have implications for meal size recommendations? I mean, because we will be getting a weight guideline, and what you just said could be interpreted as eating a large serving of, say, a high glycemic index food could have the effects that we heard about yesterday, for example.

DR. PI-SUYNER: Yes, I think portion sizes and meal sizes are one of the big problems in America. I think people have gotten used to extraordinarily portions and the common now is something that is very uncommon in much of the rest of the world. So, I think some alert to the fact that it's not so much what kind of food that you eat, but the portions overall, if you could cut them back, you would cut back on your calories.

I still think that the primary problem is calories in the United States, and clearly, you can have a very low glycemic index diet, and if you take a lot of it, you're still going to get a big insulin demand.

DR. GARZA: Rachel?

DR. JOHNSON: Thank you very much. You've mentioned what you just said about the total calories and the fact that you don't think we should recommend limiting carbohydrate. I wondered if you'd like to weigh in on the total fat message and total calories, and it's relationship to obesity, and whether you think it's prudent to keep a message to limit total fat to 30 percent, or whether you think total calories is really the ultimate message that we should try to get across?

DR. PI-SUYNER: Well, I think total calories is the ultimate message, but I really -- I feel very comfortable with the 30 percent fat recommendation. I think zigzagging around all the time is not good for us and it's not good for the American public. And, I think the NCP guidelines have been widely distributed around the country. I think they've been accepted quite well.

Proportional fat has gone down, but I guess total fat has stayed up, so we haven't made much of a dent in the total fat. But, and so therefore, I think we still need to do that. By far, the biggest killer for metabolic disease is cardiovascular disease, heart disease, and clearly, there's a relationship between total fat and saturated fat, at least with the way I read the literature and coronary heart disease. So, I have no problem with the NCP guidelines for fat.

But, I would also strongly recommend caloric, you know.

DR. JOHNSON: Thank you.

DR. GARZA: Johanna?

DR. DWYER: Just two other questions. One is, do you think we should talk about beverages and foods high in added sugar, and could you also elaborate a little bit on this glucose toxicity here?

DR. PI-SUYNER: Yes, I would say something about beverages, because I think they're growing at an enormous rate and it really is something that is not necessary for the American public to eat at that very large amount, and it brings, in a sense, truly empty calories into play in the American citizenry.

So, I think some cautionary comment about sugar-containing beverages would be a reasonable thing, from a caloric point of view.

With regard to glucose toxicity, glucose toxicity is something that occurs in diabetic individuals. It doesn't occur in normal individuals. Your normal population will not have anything, even if they take a high glycemic index diet, glucose toxicity will not come into play. Glucose toxicity is when the glucose level gets so high that it affects the ability of the beta cell to secrete insulin, and the beta cell gradually decreases its response. It's as if it gets tired from this continual stimulus at a very high glucose level.

So, if you get people who have glucoses above 250 milligrams percent continually over time, you get a glucose toxicity effect and the beta cell does not respond appropriately, and your insulin secretory response goes down.

But, that is strictly in diabetic individuals who are out of control, and has nothing to do with normal metabolism and glucose in the normal population.

DR. GARZA: I have one or two questions. If one looks at the U.S. population and the high prevalence of obesity, do we have enough data to say anything about the role of high glycemic index foods and the metabolic responses among the obese versus the lean, or from your read of the literature, there are no differences in the metabolic responses between obese and lean individuals?

DR. PI-SUYNER: No, what happens as people get overweight and very obese, the metabolic response which I would translate you to say as the insulin response, goes up four or five-fold in an obese individual anyway. And, so, then, the differences between a high glycemic index food and a low glycemic index food become less, because your total amount of insulin coming out is much higher.

It's much easier to get differences in glycemic index foods in lean individuals than it is in obese individuals, because you're starting at a much higher threshold with a much greater response to the meal.

DR. GARZA: So, the concern that we've heard expressed, that individuals who choose to lower their fat intake, either because of the desire to lower their risk to cardiovascular disease, or because they use it as a strategy to lose weight, replace those calories to some degree with a high-carbohydrate diet, and that in employing that strategy, we put them at risk because of the supposed metabolic responses to glycemic index foods. In those scenarios, you would then say for the same reasons you just gave us, that that's not a solid view?

DR. PI-SUYNER: No, I don't think that's true. First of all, and there are a couple of things, one is that, you know, I've shown you the data of glycemic index taken a single meal -- just the food. You take pasta and you boil it and you tell somebody to eat 50, 75 grams of pasta and you measure the glucose. Nothing on the pasta, that's it.

As soon as you go to mixed meals, you change the glycemic index, okay, because of many factors. One is, the fat slows down, in the meal, slows down the carbohydrate transfer. The carbohydrate transfer is much faster when it's taken alone, out of the stomach, goes out of the stomach into the duodenum and is absorbed much faster than when fat is mixed with it and when protein is mixed with it.

So, the glycemic index differences drop when you get a mixed meal. So, right away, you have a difference between a single, pure carbohydrate you're testing and the carbohydrate as you're eating it, which is mixed with vegetables, fat, protein, etc. And, the differences shrink when you do that.

I think that the trouble with people continuing to gain weight on a low-fat diet is that if they only restrict, if they substitute the fat, carbohydrate for the fat, then they will take the same calories and continue to gain weight. I think the message is not to substitute. It's not to say you can eat as much fat as you want. It's to say, don't substitute for the fat you've cut out with extra carbohydrates. Because, I think it's not the carbohydrates that are driving this, I think it's the calories that are driving it. And, what people have done is, they've switched from fat to carbohydrates. And, so, they're eating the same number of calories and so they're continuing to gain weight.

DR. GARZA: Is there any data that suggests that certain ethnic groups in the U.S. that are predisposed to Type II diabetes because of genetic predisposition are at any higher risk from diet that have a high glycemic index?

DR. PI-SUYNER: I don't think so. I don' think there's any data. Clearly, the population that is most at risk, I would say, is the Hispanic population, the Mexican-American population, which has a very high incidence of diabetes and growing rapidly in Mexico itself and in Texas. We don't have much data from California. Most of the data that we have is from Texas, but I assume it's the same in California.

We have very little data from Caribbean Hispanics. Very little data from Puerto Ricans, Dominicans, etc. Most of the data is from Mexican-Americans from Texas, and clearly, they have a high risk for diabetes and clearly, their diabetes incidence is going up.

Now, what has changed in their lifestyle? Well, all kinds of things have changed. You know, they're much more sedentary than they were. They eat much higher caloric intake and that caloric intake, the extra calories that they've added to their traditional food are generally fat calories, okay. In Mexico, traditionally, they ate rice and beans, okay. Now, they've added cheese, they've added sour cream to their -- they've added, they fry the tacos. They used to just steam the tacos. So, the changes have been not so much adding extra carbohydrate as adding extra fat to this diet, which added extra calories, which increased their BMI, which increased their risk for diabetes and cardiovascular disease.

So, I think it's the calorie effect rather than a carbohydrate effect.

DR. GARZA: Any other questions? Johanna?

DR. DWYER: Would you continue the guidelines such as the one in the '95 guidelines, adding beverages and foods? Add more emphasis to added sugars or get rid of the whole thing, or do something else, if you were on this committee?

DR. PI-SUYNER: You mean, to give a recommendation on the beverages?

DR. DWYER: One of the dietary guidelines last time involved sugars and I wondered how you would change it, expand it --

DR. PI-SUYNER: Well, I guess I don't recollect it exactly. I wouldn't want to say how I would change it. If you could read it to me, I'll tell you what I think.

DR. JOHNSON: Choose a diet moderate in sugars.

DR. PI-SUYNER: Pardon?

DR. JOHNSON: Choose a diet moderate in sugars.

DR. PI-SUYNER: I think that's fine. I wouldn't be, I think that's very acceptable. I think, as I mentioned, I believe that that's a way Americans are getting calories that they don't really need, and it's sort of empty calories and it's perfectly reasonable to suggest that they be moderating how much they take of that.

DR. GARZA: Meir?

DR. STAMPFER: I think it's easy to see that the glycemic index evokes not only insulin, but almost sort of a religious zeal. I'm not going to take time for a point by point discussion of the Salmeron papers, but I would encourage the committee to have a look at them and draw their own conclusions.

Just to make a couple of comments, though, of course diet is hard to measure and if you're going to study chronic disease, you have to measure it in a large number of people, and that means measuring it with a certain amount of error. But, in a prospective study, that kind of misclassification generally leads to an underestimate of the effect.

My second comment relates just to the very part of the talk, where the implication was made that as societies go from a traditional high carbohydrate to a more high-fat diet that they get more diabetes. That is certainly true, but clearly, this can be mostly, if not entirely, attributed to obesity and physical activity. In the traditional society of Crete, for example, with about 48 percent of calories from fat, also had very, very low prevalence of diabetes when they were active and lean.

DR. GARZA: Richard?

DR. DECKELBAUM: Xav, can you comment on the potential differences in complex versus simple carbohydrates on satiety?

DR. PI-SUYNER: I can't comment on it, because there's no real data that I know of, good data, on the difference. Generally, you know, the thought has gone that simple carbohydrates are more rapidly absorbed. However, some of the simple carbohydrates that humans eat are not sucrose or glucose. A lot of them, they eat quite a lot of fructose, too, which doesn't raise the glucose very much, and certainly almost doesn't raise the insulin at all.

So, there have been specific studies comparing fructose and glucose and sucrose, showing that glucose gives you the highest insulin, sucrose the next and fructose the least, as you would expect.

Lactose is pretty close to glucose. I don't know of any, I don't remember recalling studies with lactose, itself. That's not a big player. If you go head to head with complex carbohydrates, taking complex carbohydrates as a starch, starch is a series of glucose molecules and has almost identical glycemic index to sugar if it's cooked. So, the glucose molecules are really hydrolysed very rapidly and absorbed just as rapidly as glucose alone.

Flour that is not cooked, of course, takes much longer, but who eats uncooked starch? Not many people. The rest of the complex carbohydrates, probably the slowing down of the glucose absorption is more related to the fiber content, although this has always been a difficult issue than it is to any inherent characteristic of the carbohydrate itself.

DR. GARZA: Xavier, could you comment on the point that Meir just raised of the differential effects of biases in methodologies versus noise in the methodology? Most of the points that you made in terms of your review of the paper spoke to noise, and generally when there is noise in data, then relationships of the type that you looked at would obviously be attenuated by noise. If there are biases in the data or the methodology, then obviously, one can then look at spurious relationships.

DR. PI-SUYNER: No, I don't think -- I wouldn't call it bias and I wouldn't call it religiosity. I would call it looking at the data and seeing what you see. I think there is a lot of noise in the data. I think it's a very imperfect measure, glycemic index, it's very variable. As I said, it will change even with a given food, according to the ripeness of the food, the way it's processed, the way it's cooked, etc. So, I think there's a lot of noise and it's how you interpret the noise, I would guess, would be the answer.

And, the second is that there are very few long-term studies. I mean, I think that's the big problem. Most of these studies are one-meal studies, and I don't think you can recommend something for a population on single-meal studies. I think you've got to go to longer-term kinds of trials.

DR. GARZA: In the six-month study that you reviewed, the European paper, were those done in lean individuals or obese individuals?

DR. PI-SUYNER: They were done in lean individuals.

DR. GARZA: Scott?

DR. GRUNDY: So, in, sort of in summarizing what you say, is that from a metabolic point of view, all carbohydrate is the same for practical purposes? You can dissect out little tiny things with different foods and so forth, but taken as a whole, there's not a lot of difference from a metabolic point of view from different kinds of carbohydrate, is that what you're saying?

DR. PI-SUYNER: I think you've hit it just right. There's not a lot of difference. There is some difference. There's not a lot of difference. I think all the arguments have come around that there's not a lot of difference.

As I mentioned, that trial, the Salmeron trial, the difference between the lowest quintal and the highest was like nine index points. So, I think the problem comes in the confusion of how you're going to change what you're going to recommend and not recommend, what foods you're going to call good foods and bad foods, given the variety and the variability between these foods.

I would be happier if your committee would deal with calories and portion sizes and fiber and not deal with glycemic index. I think you'll hit a lot of it with fiber.

DR. GRUNDY: There used to be a lot of discussion about complex versus simple carbohydrate and their different metabolic effects, but you kind of downplay that, too?

DR. PI-SUYNER: Yes, well, starch, that was, years ago, we used to tell diabetic patients not to eat sugar, they should eat complex carbohydrates. That's where the term came from.

DR. GRUNDY: Right.

DR. PI-SUYNER: The recommendations to diabetic patients. And, then, some people actually did some experiments and found out that, you know, that starch could be absorbed just as rapidly as sugar, so the recommendation changed. When you cook starch, glucose absorption is as rapid as with glucose.

DR. GARZA: Alice will have the last question.

DR. LICHTENSTEIN: Isn't there also another factor with sugar versus starch, that now a lot of the things we traditionally thought of as high sucrose or glucose are now fructose, so the high-fructose corn syrup is being used instead of corn syrup which was high-glucose? So, there's been a shift in the available simple carbohydrate in the diet?

DR. PI-SUYNER: Well, that's true. In the marketplace, there are now more high-fructose foods than there were ten or 20 years ago, as people have shifted to using fructose in syrups and jams and jellies and so forth.

DR. GRUNDY: And, fructose is not a bad thing?

DR. PI-SUYNER: Well, fructose, you know, you get into a whole -- if you feed rats fructose long enough, they become insulin resistant. And, Reaven showed that in a series of papers.

So, if you eat a lot of fructose, it probably is not good for you, but small amounts of fructose, as people would generally eat -- I mean, you're not going to eat tons of syrup, in terms of a glycemic index and insulin demand, is much lower than sucrose or glucose, because fructose goes right to the liver and it doesn't ever get out into the general circulation most of it. So, there's not a stimulus for the beta cell to respond.

DR. GARZA: Okay, thank you very much. We're going to move onto a discussion of the sugar guideline, because Dr. Johnson has a plane to catch, because of some important events in the family.

DR. JOHNSON: Okay, thanks very much. What I had planned to do was to go over each of the public comments and give response, and then raise three or four issues that the working group would like the total committee to reflect on.

Thanks very much to the staff for providing this list, and I believe I addressed everyone of those in my preparation for today, except for the last one. So, I'll put that up and then we'll go through it. But, what we have first is the response to the public comments and I will start out with the first comment, which is to strengthen the advice.

There was some testimony that we should define moderate, define the word moderate as it applies to sugars. And, the only definition that I could find currently is that in some of the food guide pyramid materials, they do state that added sugars should balance calories, but not exceed current recommendations. And, I have been told by USDA staff that these are not meant to be recommendations. What they are is that when they created the pyramid and they met all of the requirements from the various food groups, this was what was left over in terms of sugar calories.

But, that is, you know, one thing that's out there is this six, 12 and 18 teaspoons, depending on the different calorie levels. These are substantially lower than current intake, and I think we do describe current intake in the document that you have. But, those teaspoon levels are substantially lower than current intake.

Another recommendation was to change the wording and choose a diet low in added sugars and the work group had recommended focusing the guidelines on added sugars.

DR. GARZA: Rachel, before you take that off, could you give us a sense of what six teaspoons would be equal to in terms of a soft drink or jam?

DR. JOHNSON: How many teaspoons of sugar in a soft drink, 12? Thirteen? So, it would be half. I believe there's about 13 in a 12-ounce soda, so that would be half a soda. That would be six ounces of soda, so it is quite low. Oh, I'm sorry, the last one, no, I did that one.

Okay, the next one on the list was added versus naturally occurring sugars and there was testimony that we should distinguish between foods with added and naturally occurring sugar, and I would say that the work group concurs with this and has done that in the draft document.

The next on the list is consumer perceptions. I think we've had three or four consumer focus group studies that have been presented to us. The first that we've already discussed at this meeting, or no, the first was that consumers believed sugar-containing foods in moderation are part of a healthy diet. I don't think that the guideline or any of the materials that have been developed to date contradict that.

The second was that consumers are confused by the message to moderate sugar intake but eat plenty of fruit, and we've already discussed that. That was from our early consumer focus group study that we had.

The next was a recent consumer focus group study we were provided, that said that consumers don't understand the added sugar term, and they used an example that somebody asked if that meant that you add sugar to a Coke? So, there does seem to be some consumer confusion about what we mean when we use the term "added sugar".

And, the last was some work that said there's no further benefit to consumers when a distinction between added and naturally occurring sugars is made. And, I would urge that the Consumer Dietary Guideline Study that we were provided with -- is that a Carole, of the questions?

MS. DAVIS: It is a draft.

DR. JOHNSON: It's a draft, so if we wanted to make some suggestions, I would think, at this meeting on the questions regarding added sugar --

MS. DAVIS: No, no, to be clear, I used the term draft because it hasn't been out of OB clearance.

DR. JOHNSON: Okay, because I did note that the terminology in that report is not what -- I can talk to you about it. It's not exactly what the committee had used for the suggested wording.

But, I would think that this consumer group study could focus on the best terminology to communicate the intent of the guidelines.

Okay, sugar and BMI. There was no association shown between sugar intake and BMI, using the CSFII database. Whenever you look at this, it's always very critical when you look at these studies on sugar and BMI, to notice whether they're talking about total sugar or added sugar, because as we know, total sugar includes lactose in milk and dairy products and fructose in fruits. So, you need to look at it critically in that way.

This one CSFII analysis was based on one-day dietary intake data, and I think it's important to remember that self-reported height and weights were used. Madelyn Sigmund Grant from the University of Nevada presented the committee with a good description of some of her work and she talked about the weaknesses of any comparison with the CSFII data, the one-day food intake data and BMI, because of the nature of the intra-individual variability you have in one-day intake, as well as the fact that the BMI was self-reported.

There is a paper by Rip Troiano that is impressed right now with AJCN, using the NHANES data, measured height and weight, and he found that soft drinks contributed a significantly higher portion of energy for overweight than for non-overweight children and adolescents. And, we were provided with that paper fairly early on in our deliberations, but I have a copy of it if anybody would like to see that specifically. So, there's some information on sugar and BMI.

The next was no separate sugar guidelines. The testimony said to focus on total diet, do not single out sugar and to emphasize physical activity. I believe that the work group is recommending retaining a sugar guideline and the justification is in the draft document, and we certainly are considering the addition of a physical activity guideline.

The next was to clarify terms. There was a request that we define sugar and currently, in the current draft, the work group is recommending the USDA definition that's used for added sugars in the CSFII database. So, that might clarify that a bit, in terms of providing a definition.

The next was glycemic index testimony. We had testimony to include the glycemic index and to not include the glycemic index, and the work group is recommending more research at this time to determine if diets high in sugar or glycemic index are linked with the etiology of non-insulin dependent diabetes mellitus, but the work group did not feel that they wanted to move forward with including glycemic index at this time.

Eating out, there was testimony to note the high levels of added sugars in restaurant food. And, although the work group did not single out restaurant foods, per se, we have included a list of foods high in added sugar to be added to the booklet.

Sugar substitutes, there was testimony that the sugar substitute asasolstane potassium be added to the list of sugar substitutes in the document. This sugar substitute does have FDA approval for use in the U.S. Currently, sorbitol, saccharin and aspartame are listed, and I have no idea what the consumption of that particular sugar substitute is. I thought that maybe we could get some data on whether it's a widely used sugar substitute or not, because I'm not sure. I looked in several textbooks that I had to try and get some information about it, but didn't come up, you know, quickly with an answer. So, I think we could do some background work on that.

Soft drinks. There was testimony about soft drinks regarding fluid intake, hydration and energy needs. The gist of the testimony was that children and adults need fluids. Children have been shown to drink more fluids when beverages are flavored, and that soft drinks can play a role in maintaining or improving weight, because the original '95 guideline said that we should maintain or improve body weight.

So, my question to the committee is, should the guideline mention fluid requirements and the role of soft drinks, both regular and low-calorie, in meeting fluid requirements? And, I was assured that we could get some data on fluid intake to see if dehydration is a problem in the population.

Okay, sugar and chronic diseases or obesity. The testimony was that there is no link between sugar and chronic disease and obesity. Our draft document does discuss some links with weight and carbohydrate-containing beverages. There's been some work by Barbara Rolls and Jim Hill, as well as Rick Mattes, showing that carbohydrate-containing beverages, that energy intake is less well regulated when the calories occur in beverages versus food. So, we have mentioned some of that.

The dental carries piece has not been changed from the '95 guidelines. In the report to the Secretaries, we did add something about fructose and colorectal cancer, primarily based on recommendations from the World Cancer Research Fund and the American Institute for Cancer Research saying that sucrose seems to play a role in colorectal cancer.

Coronary heart disease and NIDDM, the work group is recommending more research in this area and does not make any statements linking sugar with either heart disease or diabetes.

Added sugar, again, and coronary heart disease. The work group believes the evidence is inconclusive and is recommending further research on added sugar and hypertriglyceridemia and dyslipidemias.

Proposed wording, I had picked out, I'm sorry, the nutrient density is not on this list. When I went through all the testimony, I did pick up some testimony about nutrient density, so I thought it was important that we look at that. Some of the testimony said that added sugar displaces more nutrient-dense foods and other testimony said that sugars were not linked to nutrient density of the diet.

The draft documents cite research demonstrating that high intakes of soft drinks which are clearly the number one source of added sugars are negatively associated with intakes of milk and these are papers by Gunther, Harnack and Skinner, as well as being negatively associated with intakes of riboflavin, folate, Vitamin A and C, calcium and phosphorous, and this is in children who are high consumers of soft drinks. And, this was the paper by Harnack. And, that soft drinks were also positively associated with energy intakes, again, in children who were high consumers of soft drinks.

The proposed wording, i think I've discussed already and the last testimony, which I just received yesterday, was something about sucrose and calcium, high levels of sucrose leading to increased calcium excretion, and I can't really comment on that without doing my homework, unless there's somebody on the committee that may be more familiar with this literature than I am.

I think that pretty much sums up the public testimony. Some of the issues that the work group has raised, that I think would be useful to have some input from the whole committee on is the change in emphasis of the guideline. As Carole Suitor nicely pointed out for us, the focus of the draft document is now on moderation, using that term, "go easy on" beverages and foods that are high in added sugar. And, this really is a different, a shift from the '95 guideline that focused on a total diet moderate in sugar.

So, I think we need to talk about whether we want to focus on particular foods that are very high in added sugar and their effects within the diet, or do we want to continue this message of a total diet that's moderate in total sugars? And, I think it would be very useful to have some input on that.

In terms of consumer confusion, I want to go back to that, that consumers don't seem to understand the term, "added sugar," and whether that's a matter of education or whether it doesn't really matter. When we say sugars, I'm not sure consumers are really thinking about milk and fruits or other foods that are high in sugar. But, we should probably have some discussion about that.

This idea of whether or not foods with added sugar have a displacement effect on the diet, the published literature demonstrates this displacement effect in children and adolescents. I have not found published literature in adults that -- I'm not saying that the effect is not there. I'm just saying that the literature is not available. But, we have clearly seen it in children. Morton and Guthrie published a paper saying that increased energy intake in between the last two surveys, between '89 and '95, have been associated largely with carbohydrate intakes largely attained from soft drinks. Carbohydrate intakes have gone up, primarily from soft drinks. Micronutrient intakes have stayed the same, except for calcium, which has gone down.

Soft drinks have been shown to displace milk in children's diets. Again, three papers have shown that. And, high soft drink consumers having this lower riboflavin, folate, Vitamin A and C, calcium and phosphorous intakes and higher energy intakes. Again, all these data are in children or adolescents.

Again, this issue of sugar and BMI, the CSFII data showing no association, using self-reported height and weight. The NHANES data showing an association between soft drinks contributing a higher proportion of the energy in overweight than non-overweight children and adolescents, and then this work that I've already mentioned about energy intake regulation with carbohydrate-containing beverages.

And, then, lastly, we did address this a little bit yesterday, but in the draft document, it alluded to the fact that sugar might be in a second tier, and I just wanted to point out what has happened in terms of consumption, that core sweetener consumption has increased 16 percent from 1982 to 1996, going from 27 to 32 teaspoons per person per day during this time, so there is a clear increase in caloric sweetener consumption, that I thought it was important that we know about as we think about where to place these guidelines.

So, that is my review of the public comments and some of the queries from this work group and I would be happy to take comments, questions, discussion.

DR. GARZA: Any questions for Rachel? Yes?

DR. TINKER: Rachel, thank you. Do you know from the literature on the increased sources in the beverage that have the sugars, if that's mainly consumed outside the home or inside the home, and whether there needs or would benefit from a comment in the guidelines that direct people to where they may put their attention? Because if they keep thinking about in the home and going out to eat is something special or out to fast food is something special, and they just blow that off --

DR. JOHNSON: I can't answer specifically about soda. There is a good booklet that USDA did about eating away from home. We know an increasing number of calories are eaten outside of the home. I'd have to examine that to see if they single out soda as a food. I believe I've seen some data that said that meals at home are more likely to have other beverages than soda, but I'd have to check that. I know I've seen something. Good question, to emphasize the eating away from home.

Joanne?

JOANNE: Can I say something about eating out data?

DR. JOHNSON: Yes, thanks.

JOANNE: Isn't (inaudible) easier across time, multiple databases, but calcium density of most away from home food sources was significant in school meals, where milk is a required beverage, weren't much lower. So, I think you can draw a sort of obvious inference.

DR. JOHNSON: Thanks, Joanne.

JOANNE: I think there have been some smaller studies that did say what we said about women's propensity to consume milk versus other beverages outside the home.

DR. JOHNSON: Thanks. Joanne is the author of that paper so we know it's reliable.

DR. GARZA: During the confusion, the consumer confusion over the word added, what other terms have the work group considered, other than added sugars?

DR. JOHNSON: I can't say that we've really considered anything else, just whether to add the word "added," would you say, Alice?

We just learned of the confusion. I got that report in a Fed Ex package that I think we got on Tuesday, so we didn't really have time as a work group to address it.

DR. LICHTENSTEIN: When you're trying to ferret out the sugar that's consumed with meals versus out of the house, if it could be separated also out by school, because we saw some information at the last minute, suggesting that some school systems now were offering and even encouraging the consumption of soft drinks.

DR. JOHNSON: Well, in fact, there is a bill in the Senate right now introduced by my Senator Lahey and some other Senators. Apparently, there is a loophole in the law, because in elementary and middle schools, the machines that sell foods with minimal nutritional value, if you're participating in the USDA School Nutrition Program, can't be turned on until after the last lunch period, so there are some soft drink companies that are giving soda away free during the lunch, during the noon hour, because they can't sell it. I would imagine that it's done to develop brand loyalty on the part of children fairly early, and there has been a bill introduced in the Senate to close that loophole in the law that says they can't give away free soda at noon. But, I haven't heard anymore other than just that the bill was introduced.

DR. GARZA: Richard?

DR. DECKELBAUM: I would like some guidance on the role of focus groups in how we present our documents, both in terms of the booklet and in the green book. Because, if we're being asked to use evidence-based documentation for what we say, I can understand the focus groups are pretty important in whether perception of what we think is good wording translates into what the public thinks is good wording.

But, in terms of the science, because here we're debating a major term, "added sugar" versus "sugar," and, you know, maybe it's not the perfect word, but we sort of know what the concept is. What's the role, then, of the focus groups in guiding our exact wording and this scientific basis for putting down a recommendation in both the brochure and the green book?

DR. GARZA: I'm not sure what the status of the focus groups were. Carole, can you brief us?

MS. DAVIS: Well, what is happening is the focus groups moderators guide is in clearance now and we're expecting to have focus groups probably in July, and the results of that would not be available to you until sometime in August, and this would be the first round, where we're trying to get some information about concepts that just would guide you, to some extent, and then later on, when you have another draft, we will be testing sections of that, like maybe you think would be a problem, the weight guideline, parts of that. Part of whatever it's called, variety guideline.

And, this would be probably in September, almost. Some of these results are going to be helpful to us in putting the publication together. But, there's a lot of material out there already.

DR. GARZA: So, as a guide, but not necessarily anything beyond that.

DR. DWYER: Rachel, thank you for what I think was a very thorough presentation. I think there are a couple of other artificial sweeteners, suculose and so forth, that didn't get mentioned in the draft.

The energy density is mentioned, that whole argument is mentioned in the sugar one, but then it isn't mentioned in the fat one and I think that's a mistake. We need something on total fat and energy density.

And, finally, I'm totally confused by the different submissions. I think the first dietary guidelines meeting, we had a man present consumption and I didn't really follow it very well. Now, there's additional. What is the true increase one can, if you adjust for the definitional differences, what is the increase, because it seems to me that the size of that increase, if it can be determined, would be critical in making a decision between focusing on added sugars and total sugars?

DR. JOHNSON: The numbers that I took were from an ERS document. I believe the first author is Cantor, that I have with me and I can pull out, that looks at caloric sweeteners. There has been some debate about this definition of added sugar and how it's operationalized. I think clearly that when you look at consumption data, you look at disappearance data. You can, in that document I was referring to, it has some excellent charts showing what's happened to soft drink consumption, which, I believe, is contributing about a quarter of all the added sugar in U.S. diets. There's been a clear increase in consumption.

I think it's pretty hard to argue against an increase in consumption of total added sugars.

DR. DWYER: The question is how big?

DR. JOHNSON: Well, from that Cantor article I showed you the last slide, it was at 16 percent since '82.

DR. DWYER: Is that disappearance or is that consumption?

DR. JOHNSON: It's disappearance.

DR. DWYER: Well, I guess consumption would be better to look at.

DR. JOHNSON: We can get consumption of particular foods. I'm not sure we can get consumption increases using the USDA added sugar definition, because as the older surveys were not coded in that way, is that correct, Shanthy? It's only with the newest '94, '95, '96 survey that you have the ability to pull out added sugars, because that's the first time they used that definition. Otherwise, we'd have to look at total.

Oh, you did? So, we could look at the difference between '89 and '95? Okay, for added? Okay, that would be useful. We could do that.

DR. GARZA: Shiriki?

DR. KUMANYIKA: With this sugar guideline, I'm wondering if you can see a way to relate it to the other guidelines rather than or in addition to having it as a separate guideline, because the issues relate to weight control, they relate to replacement for fat intake, fruits and vegetables and so forth. So, I think also with the sodium guideline, these ones that have to do with qualitative differences within a particular food category and things that are added. Have you thought about the sugar guideline as phrased, mainly in terms of how it breaks out for the other guidelines?

DR. JOHNSON: I guess I have. I guess my concern with folding it in with the other guidelines is, it will lose some attention in and of itself, and when you think about the public policy implications of these guidelines and what the sugar guideline means in terms of the WIC program, the school nutrition programs, unless we're very clear and it's very, very clear within the context of some other guideline, I think it could have some really, really profound policy implications.

DR. KUMANYIKA: I didn't mean folding it in.

DR. JOHNSON: Oh, okay.

DR. KUMANYIKA: I meant expressing it. In other words --

DR. JOHNSON: Keeping it as a guideline, but --

DR. KUMANYIKA: You have these other guidelines, then you get to sugar and this tends to be written as a guideline to stand by itself when, in fact, what it's doing is giving you information about choices related to other categories, and I'm wondering if there's a way to make it clearer so that people can integrate the information better, rather than see this as yet another consideration, because they've already passed through sugar considerations in the other guidelines. It's not linear, but I think if you pass through the weight guidelines and you've thought about all your weight issues, that's when you should be thinking about the contribution of sugar and total calorie intake, not as a separate issue or in the same with fat.

DR. JOHNSON: So, I guess I'm not sure. Are you arguing, you're still saying keep a sugar guideline, but somehow integrate it?

DR. KUMANYIKA: The way it's presented and framed to keep it from seeming like an additional consideration, to express it more in terms of how it relates to the advice they've had about food group choices and total calorie intake.

DR. JOHNSON: Yes, I think that's a good point and Carole and the work group, maybe we could work on integrating it better?

DR. GARZA: Roland?

DR. WEINSIER As usual, Rachel, you do such a great job and you're so organized. Stepping way back to see if I can play consumer here, the feeling I got from reading this and see if these are the points you wanted to make, because these are the points that I took from it, is that the primary problem is particularly among children and adolescents getting too much sugar, particularly from soft drinks, and the associated behavior problems, weight problems and health problems. That's the problem.

So, it's a pediatric focus, soft drink focus. The solution is that use less soft drinks and substitute with milk, low-fat milk. I may be interpreting wrong, but that's the flavor that comes across and my question is, number one, is this really a primary pediatric issue? And, it may be, and number two, is the behavior changes you want to primarily switch from soft drinks to milk? What about water? What about -- I mean, cause there's no mention of water. Is that not a substitute that you want to recommend, particularly if there's a concern about calories?

DR. JOHNSON: No, I think you've made two very good points. One is, the data exists in children and adolescents. That's the focus on that group in the document. I'm not saying the problem doesn't exist in adults, but there's no data. That's why the focus.

The second, I think, is an excellent point, because I think we have seen this displacement of facts with soda and milk, and clearly, children's calcium needs are very high. They're getting 75 percent of their calcium from milk and dairy products, so we need to emphasize that, but there may be children that are meeting their calcium needs, that are also adding calories with soda, that certainly we could encourage another type of fluids, particularly water, as a good substitute. And, I think that's a good point that we could put in there about encouraging water consumption, sure.

DR. WEINSIER Can I follow up? This is more of a worrying thing, but I don't think wordsmithing. Under Box 15, one of the bullets is, "Eat a variety of foods from the Food Guide Pyramid for healthy teeth and gums." Does this get back to what we're trying to do with variety? It's the issue that Suzanne and our subcommittee have tried to deal with, what point do you want to make when you say eat a variety of foods from the Food Guide Pyramid and how does that help with healthy teeth and gums?

Are you trying to say that the foundation of a healthy diet which is going to reduce risk of dental disease is the five basic food groups in the Food Guide Pyramid? Is that what you're trying to say?

DR. JOHNSON: Now, this is not changed from the '95 book. We didn't make any changes in the dental area, is that correct, Carol?

DR. SUITOR: Very minor.

DR. JOHNSON: Very minor.

DR. WEINSIER So, just tell me what the point is you're trying to make and then see if maybe I'm just misreading it? Is the emphasis on variety, is the emphasis on choosing the right foods? This is on page --

DR. JOHNSON: Right, page 44.

DR. WEINSIER -- 44, under Box 15 for healthy teeth and gums. It's the first bullet. Tell me what the point is you want to make and then we can figure out if the words do say it or not?

DR. JOHNSON: My guess, since I didn't write this and yes, this is from the '95 booklet, is that the -- oh. It's not, so did we add that line? We must have.

DR. WEINSIER You probably stole it from our variety guidelines.

(Laughter.)

DR. JOHNSON: Okay, so in the '95 booklet on page 35, it just says, eat fewer foods containing sugars and starches between meals. And, then we added, "Eat few foods or beverages containing sugars and starches." I think, Johanna, at one point, you wanted something added about stickiness, didn't you?

DR. DWYER: Well, I don't think that's what the Dental Association calls it. I think it's called retentive fermentable carbohydrate. Now, how you put that into nickel and dime words instead of fanciness, I don't know, but the basic notion is.

DR. LICHTENSTEIN: The dried fruit, that you brought up.

DR. DWYER: Things like dried fruits, that you said before.

DR. WEINSIER Well, you don't need to resolve this now for my sake.

DR. JOHNSON: I wasn't trying to make a point. I don't really know how that line appeared there, but I'm not married to that line.

DR. WEINSIER If the subcommittee could just think about it, I just wasn't clear on what the message was.

DR. JOHNSON: Okay.

DR. GARZA: Alice?

DR. LICHTENSTEIN: I guess I'm a little perplexed. When I read this, I don't see where we're actually recommending milk intake as a substitute, although I might personally be a proponent of it in addition to water. But, as I read this, I don't see where you're getting that?

DR. WEINSIER I don't know, it's fairly short, concise and the way it should be, it's pointed, and the first paragraph and the closing paragraph allude to that.

DR. LICHTENSTEIN: No, they allude to displacement of milk by soft drinks.

DR. WEINSIER The first paragraph --

DR. LICHTENSTEIN: Yes, displacement.

DR. WEINSIER And, the second and the last paragraph.

DR. LICHTENSTEIN: No, but the last paragraph is talking about all the food groups, and the first paragraph is just stating the observation of displacement. But, I actually, in reading this and being on that subgroup, I don't see where we're specifically saying that you --

DR. JOHNSON: Well, actually, I'd like to make the point that there have been rumblings, you know, that we need a calcium guideline because of what has been perceived as a calcium crisis.

DR. LICHTENSTEIN: Right, but I'm just responding to what's written here.

DR. JOHNSON: I'm just wondering if this is the place and the guideline to raise some of these issues about calcium, unless it's going to happen in the formerly called variety guidelines.

DR. LICHTENSTEIN: But, again, the last sentence is really just talking about displacement.

DR. WEINSIER "Take care not to let soft drinks crowd out low-fat milk."

DR. LICHTENSTEIN: Right, so it's displacement.

DR. WEINSIER Right, I mean, I'm just one person. That's the way I read it, because it hit me in the first paragraph and hit me in the closing sentence, that that's a very important message I should be left with, and if that's the message it should be, then it should be. I was just curious why, you know, water, perhaps other foods. Maybe you want them to drink sugar-substituted sodas or maybe you want them to drink juice. I don't know, I just didn't feel that there were options presented, other than if you're going to take away the soft drinks, which is important, then what am I left with? And, you're left with milk.

DR. JOHNSON: Actually, that's just based on the data that that's the food that is primarily being displaced. That, and there is, I believe it was Skinner's paper showed that fruit juice is also displaced to a certain extent.

DR. LICHTENSTEIN: Are there any data regarding water intake and whether water -- one would think it would be, but water is displaced with soft drinks?

DR. JOHNSON: I haven't seen anything.

DR. LICHTENSTEIN: It may just be that the data aren't there. I think that's the way it was worded the way it was, to be very specific.

DR. WEINSIER I understand and Rachel's point is well-made. I understand that that's what the data point to, but is that the advice you want to give?

DR. GARZA: Johanna and then Shiriki?

DR. DWYER: Rachel, on the tooth decay thing, maybe we could say something like both sugars added to foods and those occurring naturally in starches can promote food decay, especially if they're retained in the mouth, so, you get all those things. Under Box 15, one thing that isn't mentioned is drinking fluoridated water and, of course, I think that's important with the sealants and the rinses and stuff.

DR. JOHNSON: And, actually, I have heard there's a concern with all the high usage of bottled water that it's not fluoridated, that we're kind of worried about an increase.

DR. DWYER: And, the other thing is, you mentioned that in adults, there were no relationships -- I don't know if that's after taking into account alcohol intake or before?

DR. JOHNSON: After taking into account what?

DR. DWYER: Alcohol intake or before? I mean, very often, we don't want to encourage adults to substitute alcohol and added sugars.

And, finally, I favor a separate guideline. I don't agree with the focus, particularly, but I think we have to have something about monitoring of sugar intakes, and maybe there's a way to do it under a rubric. Dr. Murphy, I think, at the end of the day talked about not grouping in terms of collapsing various guidelines, but just putting them in some kind of an order, so that we had some simpler sort of framework for looking at them, and that may be one way to cope with that one, and also whatever comes up on the sodium and salt.

DR. GARZA: And, the classification, so that everybody remembers, was moderate adequacy and balance.

Shiriki?

DR. KUMANYIKA: I wanted you to clarify what data you said were not available in adults related to sources of sugar? I didn't catch all of that, and I know there are data on how much soft drinks and so forth contribute in adults.

DR. JOHNSON: The data on consumption. There is not published data on displacement effects of added sugar in adults that I've found. There is published work on total sugar, which we, I presented early in this process.

DR. KUMANYIKA: There are data, the one paper on sources, which shows the ranking of soft drinks and cakes and cookies. So, it's not displacement, but it certainly shows that they are high contributors, and it seems that that's support for pointing that out to people.

DR. JOHNSON: Right.

DR. KUMANYIKA: And, the things that are below that you might want to put up higher are --

DR. JOHNSON: Right.

DR. KUMANYIKA: -- potentially displaced.

DR. GARZA: Meir?

DR. STAMPFER: It's interesting in the nurses' study, sugar and alcohol are, as Johanna alluded to, are inversely related, at least in the women, it looked like that was being displaced. I don't think that has any relevance for our deliberations.

DR. DWYER: The men take both.

DR. GARZA: Pardon me?

DR. DWYER: The men take both.

DR. STAMPFER: Right, the men have it.

(Laughter.)

DR. GARZA: The only other comment I would make is under the heading of sugar substitutes, you may want to look at the language so that it isn't -- it doesn't warn people that you can't replace the calories. I mean, we could probably find a way to say it more directly. It suggests that if you want a sweet taste without the calories, but then it doesn't go the next step to say, that doesn't give you license, then, to replace those calories and still expect to lose weight.

DR. JOHNSON: Okay, great, thanks.

DR. DECKELBAUM: Just a couple of points that came up. One is when we did have the working group proposed, it was problematic that most of the data that we have I think was related to children and adolescents and it was a paucity in the adult population. Roland, I guess, you picked that up, because we had to base the sort of science on the pediatric or children and adolescent population.

Any suggestions on how to broaden that would certainly be welcome. And, the other point I think we should mention is a good one that right now, I guess, we're sprinkling calcium through the guidelines and there could be a greater emphasis so that, for example, if we, in terms of the replacement of, say, soft drinks, with low-fat milk, it could be low-fat milk or other calcium-rich foods. It might be an approach to put in in a few places.

DR. GARZA: All right, then, let's take a break.

DR. JOHNSON: Thank you.

DR. GARZA: Thank you very much, Rachel. We'll come back at 11:15.

(Whereupon, a short recess was taken.)

DR. GARZA: We will move on to our 11:15 presentation, if everyone will please take their seats. I am very pleased to welcome Dr. Claude Bochard who is at LaValle, but is going to be shifting from French very soon to a Cajun French, and those of us that were privileged enough to live close to the Louisiana border can appreciate the fine time he's about to start having with our Louisiana brethren.

But, Dr. Bochard is going to be the Director at the Pennington Center, and so he's going to be adding quite a bit to the scientific environment in the Southeast. Dr. Bochard is going to talk to us about fat and health disease relationships and without my taking anymore of his time, I think the crowd has especially settled down now that you could start.

DR. BOUCHARD: Thank you, Mr. Chairman. I have seen the proceedings of the previous sessions and I hope that you have a linguist going over my presentation so that it is in proper English.

I repeatedly said to the chairman that I was not the right person to talk about this topic and you are about to discover why today. It is a very complex issue and it covers so much of the health and metabolism area that obviously I will be very selective, and focus on what I believe is a very key problem in this country, and that is the relationship between dietary fat and obesity, in particular, some of the consequences of obesity.

I will first of all say a word about the controversies. I think that you can find in the literature research supporting both sides of each argument or conclusions in the literature. You will find, and I have removed about 20 slides from my presentation, but I have data to show you, yes, you can support Hypothesis A, no, you cannot support Hypothesis A.

So, I will say a word about the controversy. I will spend a bit of time on a key issue and that is the potential interactions between dietary fat and a sedentary lifestyle in fostering the current epidemic of obesity. And, finally, a word about the importance of individual differences, which should always be kept in mind when we talk about the role of dietary fat.

I guess that a key element in my presentation is summarizing this slide. There is a major public health problem in the prevalence of obesity. These are based largely on the IOTF data put together by Jack Seidell and he estimated, based on the data from almost 100 countries of the world that are accumulated in the IOTF report, that 7 percent of the world population has a BMI of 30, compared to U.S. prevalence of about 21 percent.

Now, I am about to change team and I will be -- I feel like a hockey player being traded. I will now be joining the winning team.

(Laughter.)

DR. BOUCHARD: Moving from the second best in the world at 14 percent to the superstar, 21 percent. So, in the U.S. and pretty soon in Canada, being overweight, that is, having a BMI of 25 and higher, is becoming the norm. It is now already the norm in this country and will be soon in Canada, so this is a major public health problem that we should not lose sight of when we talk about the role of dietary fat.

Okay, recently George Bray and Barry Popkin put together a very nice overview of the arguments in favor of a role of dietary fat in obesity. Like I said, I'm going to go through that very quickly. Like I said, you can always find a paper and more than one, with very few exceptions, that will show the opposite. Experimental animals did not become obese on low-fat diets. That is pretty much the very strong trend. There may be some exceptions to that, but they will be very rare, indeed.

Experimental animals become obese on high-fat diets, but not all of them. There are strains that are resistant to dietary fat, and supposedly, we also have human beings that are resistant to becoming obese on a high-fat diet, as well.

Fat oxidation does not increase in proportion to fat intake, the implications being that with a high fat intake, there would be plenty of calories left for storage, fat calories left for storage. I will come back to this. It is an important issue, particularly when this is confounded by a sedentary lifestyle. A high-fat meal is not compensated by later decreases in food intake. This is a fairly controversial area. Here, we can find many studies that are not supporting this, but we do find a body of evidence supportive of the statements.

Post-obese individuals have an impaired ability to oxidize fat, which is exacerbated when exposed to high-fat diets. This comes fairly repeatedly across sectional studies. We don't have many intervention studies or experimental studies, but the few studies that are available tend to support this statement. High-fat diets can increase fat cell numbers, which may limit weight loss. This is based mainly on animal data. There is no equivalent experimental human studies that support that at this time.

Indigestible fat substitutes cause weight loss. There are some studies showing this, but limited duration. We don't have very long-term studies yet, and some people on low-fat diets lose weight. Not all of them, but some lose about 20 to 30 grams per day of weight loss, but nobody is gaining weight on a low-fat diet, and that is also a fairly solid statement.

Now, the other view was also summarized in Bray's paper, and it pertains to the arguments, again, of the role of dietary fat in obesity. The first one is a very strong observation. It is obviously based on ecological data type. In Western nations, the prevalence of obesity has increased despite a reduction in dietary fats. I will have more to say about that, and it's one of the controversial topics that I would like to say a word about. Cross-sectional prospective studies are showing no relation or a very low relationship between obesity and dietary fat -- yes, in some, no, in others. You can find supporting both arguments.

When the relationship is there, it tends to be fairly low or moderate. It's not a very strong correlation and, of course, these studies are confounded by many other factors which are, or are not, properly controlled in these studies. And, reduction in dietary fat has little effect on body weight loss. It seems to have in the short term and the long term, the effect is generally relatively small, but again, it depends what are the other factors, what are the other determinants of energy balance that are controlled and not controlled?

So, let me stay with the controversy for awhile. This is an example of a study where we have differences between obese and lean people in fat intake. For example, here, we have in the obese, 33 grams of fat in the males versus 29 in the lean, 36 versus about 30 in the female. They are the opposite trends in terms of percentage of energy from sugar between lean and obese. That represents a whole series of studies that are supportive of a difference in the amount of fat in the diet.

In contrast, you find those where, ten individuals, normal weight individuals and overweight individuals were compared, we don't see the expected trend. No differences in percent of energy from fat and actually, the grams of fat are in the opposite direction from that which could be predicted.

So, and there are certainly dozens of studies available in literature and you can select the ones that you prefer, depending on the conclusions that you want to reach on those.

In an ecological perspective, we, for a long time, we have observed differences in the fat, portion of fat in the diet and the mean body weight of a population, or mean BMI, or, in this particular case, the percentage of those who had a BMI above 25. That is the prevalence of overweight. This was put together in the review by Bray and Popkin, and we have this fairly strong correlation between the percentage of energy from fat in the diet and the prevalence of overweight, the R2 being almost .8.

Now, we must be careful not to overinterpret these data, because, of course, they are certainly confounded by a large number of other environmental and lifestyle factors and other prevailing disease conditions. It's very hard to compare, for example, conclude on the basis of contrasting the percentage of the diets in India, Maui, China and the Philippines versus Australia and the USA or Italy, because there are many other factors besides the percentage of fat in the diet which is controverting to this prevalent issue.

And, again, if you look closely at the literature, then you can find the opposite. This is the Monica study. This is the percentage of fat, and here you have the opposite trend, exactly the opposite trend. This is the medium BMI and the high-fat diet and the lowest BMI level. So, we can go on and on and on, and depending on the conclusion that you want me to reach for you, I can select a study and build my case.

So, we have to take some other approaches. In this particular case, I'm not sure we're gaining much from comparisons of countries, comparisons of culture, culturally different nations and/or purely epidemiological approaches. Now, an important component of this debate is what is happening when you reduce fat in the diet? Again, Bray and

Popkin did a review of that literature, and they plotted here the weight loss in grams per day versus the reduction in percentage points of percent of calories from fat. And, as you can see, there is a slope, there is a slope. The R2 is .45. The difference here between this level and that level is approximately 20 to 30 grams per day of weight loss.

So, it makes a difference, but we're not sure whether, and in this particular case we're certainly not sure, if it is in the presence of everything else being taken into account. It's just the dietary fat and many of the studies are not controlling for calories or other components of the determinants of energy balance.

In contrast to the preceding, we are often shown this, this one. This is part of the Rockefeller intervention study in which some obese people are being exposed to a low-calorie, weight reducing diet to reduce their body weight by 10 percent, and then kept on a weight-stable diet to be studied at both levels of body mass. And, here we have a 60-year old woman fed 7,300 kilo joules per day on a 10 percent fat or on a 70 percent fat, and there is no real difference in body weight.

Well, this is my definition, isocaloric, so you would not expect much difference over time in body mass, if

the diet is isocaloric. If body fat, if dietary fat is playing a role, one of the ways through which it's going to exert its influence is through the caloric density and, of course, through the caloric intake. And, an example of the impact it may have on caloric intake is shown here, where we have a cumulative energy intake under three conditions. Low density food available, medium density food available, and high density food available, over a period of 48 hours, two days of three meals and a snack in both cases. And, the energy consumption on a high calorie, high density items available is clearly translating into a greater consumption of calories over a two-day period.

So, I guess if we had a large body of data in which both were clearly controlled, the density and the amount of food and the proportion of fat within this context, we could conclude that by and large, these are not controlled, except in a few instances, which I will rely upon later on.

The debate is also fueled by the fact that we see an increase in the prevalence of overweight and obesity, both conditions, in this country, in the presence of a decrease in the proportion of fat in the diet. These are data from the recent past covering about 18 years of observation, and as you can see, decrease is typical of other assessments of the changes in the proportion of fat in the diet of the U.S. population. And, at the same time as we registered this, we have the opposite trend, the prevalence of obesity.

So, those who are a proponent of a role of other macronutrients in the position to dietary fat can use this to conclude that, indeed, a low-fat diet is not, on the average, is not fueling the current epidemic of obesity -- or, rather, it is fueling the current epidemic of obesity.

The arguments on the role of dietary fat is largely based on this cartoon summarizing the nutrient oxidation issue. It goes this way. When carbohydrate intake is increased, we have a proportional increase in carbohydrate oxidation. When lipid intake is increased, we do not have a proportional increase in lipid oxidation, therefore, there is more left for storage -- the difference between the identity line here and this particular line is what's left for storage. Therefore, individuals on a high-fat diet will have a greater risk of having progressive fat disposition until they reach a body mass and body fat content sufficiently high to foster further increase in lipid oxidation.

We know that obese individuals have an elevated rate of lipid oxidation, and therefore, obesity is one mechanism by which we adapt to a high-fat diet, to balance fat intake and fat oxidation rates.

This is an important element and it has been tested in many studies and it is by and large, by and large quite robust a finding. I draw this line purposefully low, so I would exaggerate the effect and make sure that the message is understood, but in reality, it's not as low as it is here. There are differences and there are some studies that allow us to address this. This is a study we did in our lab, my colleague, Tremblay, led the project several years ago, in which it's only a 48-hour experiment, but I think it begins to show the impact it may have.

We have people exposed to high-lipid food available for the day before and for two days after an exercise bout. Low fat mixed and a high fat, approximately 20, 40 and 60 percent of the calories. Then, they all exercised for a period of 60 minutes and we subtracted the resting energy expenditure from that and the exercise was the same under all three conditions. And, we let them eat over the next 48 hours, and under the low-fat diet over that period of time, we see that we had a negative energy balance in the post-exercise period. Same under the mixed diet, but on the high-fat diet, the subjects were in positive energy balance, such that the overall energy balance over two days was about six mega joule and the low fat and the positive energy balance of about one mega joule on the high fat.

Now, this is short term and, of course, we must not over-interpret these results. But, fortunately, there are other data and better data on this issue and with great humility, I have to admit that they are much better than those from our lab. They originate from James Stubbs and Andrew Prentice and their colleagues at the Dunns in Cambridge. And, here, they registered, they obtained a contribution of seven young adult men. They kept them in a metabolic chamber for seven days, and they were exposed to three different dietary conditions, low fat, medium fat and high fat, 20, 40 and 60 percent, pretty much as in our previous study.

And, these were fed ad libitum. They could eat as much as they wanted, but it was covert manipulation of the fat content of the diet, but keep in mind they are in a confined metabolic chamber, so it's not the normal pattern of daily activities. And, here we have the food intake, kilograms of food over seven days, cumulative, no difference between the two groups. However, when we look at the energy intake, purely, the high fat condition leads to a greater amount of calories, about 85 mega joules versus about 60 for the low-fat diet, under ad libitum conditions over seven days.

Now, then, we can separate out the carbohydrate intake and the lipid intake. Here, the high-fat diet consumed less carbohydrates. The low-fat diet consumed more carbohydrates, but the opposite is true for the amount of fat consumed, the 20 percent at about 10 mega joules, the 60 percent at about 15 mega joules of fat over that week.

In the confine of the chamber, knowing that people tend to be sedentary, they don't move around as much as when they are free-living, we can see that under the 20 percent calorie content of the diet, they are in energy balance over 70. This is energy balance. Those at 40 percent were at positive energy balance by the end of seven days. They had about four mega joules of positive energy balance. But, those at 60 percent had about 16, 17 mega joules positive energy balance. Clearly, under standardized conditions, a high-fat diet, when people eat ad libitum, it leads to a positive energy balance. It would be very hard to detect under population studies or ecological studies.

Now, this was artificial, in the sense that this is a metabolic chamber. But, they did another experiment. They compared the same diet, three levels, this time for 14 days and they had the subjects coming to the metabolic chambers for the measurement, spending periods, hours in the chamber, but most of the time, they were free living.

Again, the food intake, kilograms, no difference between the two groups. Fat intake, of course, the low fat, very low fat. The high fat had a much higher fat intake, and the energy intake was higher in the high fat. The upper line, here's the high fat, so we reproduced pretty much the conditions of the previous study. All the meals were controlled, though. They were eating their meals in the metabolic ward.

But, then, because we had free living people, we had people moving around and about more, they were able to compare those who had been sedentary in the previous study versus those who were considered active, that is, those who were free living in the second study. And, under the 20 percent fat, there was energy balance as I showed you in the previous people, even in the confinement of the metabolic chamber. But, those who were moving around and about were clearly in negative energy balance by about three mega joules per day. Under 40 percent fat, you begin to have positive energy balance in sedentary conditions, but being physically active brings, keeps you in negative energy balance. But, on the 60 percent fat, both become in positive energy balance.

So, we have this interaction between activity and dietary fat. Because physical activity is a great lipid oxidizer and people would be able to tolerate a fairly high degree, fairly high level of fat intake, if they were physically active. Like marathon runners, for example, or people who walk a couple of hours a day. They oxidize grams and grams of fat. But, most people, and I think we have population data to show that, do not exercise at that level, and therefore, even on the 40 percent fat diet, there is a great risk of being in positive energy balance.

Now, we don't have many other studies that have attempted to document the same phenomenon on the population scale. There is at least one study which has taken this approach and tried to validate it in a larger setting. Here, what we have is a Scandinavian study. The six-year weight gain in sedentary women versus those who are somewhat active and those who are most active, as determined by questionnaires.

And, the weight gain is, on the low-fat diet, when people are sedentary, is essentially zero. But, even on the high-fat diet it is positive, and therefore, in both cases, the high-fat diet and the low-fat diet, you have an increase over the sedentary. And, the active doesn't make much difference except when you go from sedentary to somewhat active or active. It's not as clear as in the intervention metabolic ward data, but it points somewhat in the same direction.

Now, if the population data are taken farther than in most studies I know of, I think we get some of the same message, as well. This comes from the United Kingdom and, again, from the Danes group, Andrew Prentice and Susan Jebb, in which they plotted the prevalence of overweight in Great Britain in the high and the low social classes, as against the energy intake in mega joules per day, and the percent energy from fat. And, the data plotted as a deviation from the mean for the whole population. We can see, of course, there is a very strong gradient. The high social classes have low prevalence compared to the low social classes, very strong grade.

But, in this particular case, there is no tracking, no relationship between intake and calories from fat. While, when we look at the activity, proxies for activity, here, a proportion of inactive is derived from the number of cars they have in the household and the number of hours watching TV. There seems to be some company between the prevalence data with the surrogate for activity.

This is cross-sectionally. Then we have, over time, these data have been made available for a period of about 40 years in the UK and over time, without all social classes confounded, we had this change in the prevalence of obesity. And, here again, we see that there is very little coupling between the prevalence data and the intake data, but a better coupling between the surrogate for activity and the prevalence data.

So, I think taking, trying to isolate the specific contribution of dietary fat without taking into account the mode of life, in this case, the level of sedentariness, may lead to recommendations or perceptions that are probably right for a segment of the population, but wrong for the rest of the population. Certainly, relaxing -- relaxing the dietary fat recommendations to, with a view to increase dietary fat, would be unwise in a population which is as sedentary as that of the United States or Canada or the Western world, in general.

Now, let's, however, keep in mind that we have considerable differences in responsiveness. At least, we believe that. We don't have much human studies to go by here, but the animal data are very strong. This is an example of those. A study done by David West at the Pennington Center, where he compared nine inbred strains of mice under a 12 percent of calories from fat and 33 percent from fat. The dark bar here, as you can see, under low-calorie, that's a low-fat diet, none of them have an elevated lipid content in the carcass. But, when challenged by the diet which is 33 percent, almost three times as many calories from fat, some of them are resistant -- they don't gain fat -- but these gain fat and become fairly obese. Only the AKR/J, only this one, consumed more calories. The others did not consume more calories, therefore, the effect comes from the dietary fat, itself. So, these are differences that I assume exist in human populations. We don't have data, but there is other evidence that strongly supports the view that we have individual differences in responsiveness.

For example, challenged with cholesterol load or a high-cholesterol diet for a period of time, we know we have huge variation and responsiveness among people. And, these variations are not random. When we do these studies with identical twins, we find that there are differences between pairs of twins. Those members, brothers and sisters who are genetically similar respond fairly similarly, compared to those who are from different genetic backgrounds.

In the mouse study, the cross between -- David West crossed the highly sensitive versus the highly resistant strain, the two extremes in responsiveness to the high-fat diet. And, did some back cross and then began looking for the genes or the regions in the chromosome. We call that QTL, quantitative trade locus. You look for QTLs that were linked to body fat in the offspring of these divergent lines. And, as you can see here, this is not the full picture, but these four genetic loci were linked with the type of interest. That is, some markers of adiposity in the carcass.

And, he now claims -- that has not been published yet, but seven loci account for all of the genetic variants that he has seen, determining the responsiveness to high dietary fat versus low dietary fat. The genetic variance was about 50 percent of the responsiveness and about seven genetic loci would account for the whole. So, this supports the notion that we have individual differences and responsiveness. There are people that can tolerate more than others a high-fat diet. In the case of humans, it might be their skeletal muscular capacity, which is the higher rate, which make a greater use of calories.

So, if this is correct, if this hypothesis is correct, then a given level of fat intake will not have the same effect on body fat. It will depend on your innate characteristics. And, it is very hard to predict whether you are sensitive to dietary fat or resistant to either dietary fat, until you have been challenged by dietary fat. I know of no long-term experiments in humans. We had some data over a week, over days, but not over two to three years. And, I assume that these, it's like smoking, we will never have a randomized controlled trial to document exactly what is the extent of the differences in responsiveness to long-term exposure to a diet which is 60 percent fat or 70 percent fat.

Having said all that, that would be my last line, Mr. Chairman, it does matter if you are on a high-fat diet and gain a few kilograms of fat, it does matter. I didn't want to, I didn't have the time to spend on the implications of dietary fat on health and morbidities and mortality rates and health outcomes, but let me show you just one slide which I think demonstrates very strongly the fact that it will matter.

If dietary fat is conducive to greater density of food and creating risks for being in positive energy balance, it will translate into a few extra kilograms, until you have increased your lipid oxidation level to the point that you offset this tendency to eat more fat in your diet. So, you might be in energy balance and weight stable at five, six, seven, ten kilograms or more, because of the high-fat diet.

Then, the difference is, in my view, very important for health outcomes. And, the reason I'm saying this is based largely from that study. In Finland, where you have twin registry, a nice, well maintained twin registry, it was possible for a group of us to interrogate that registry and ask the following question. There were about 1,500 pairs of identical twins who were adult, middle-aged, that we could go to by questionnaire and ask whether they'll, what is their current body weight and height? This was part of a series of contacts with these pairs of twins, so there were data already in the bank, in the data file, on height and weight of these twins.

And, we found that there were about 50 pairs who were divergent. Identical twins, one is normal weight, lean, the other one is overweight or obese. Same genes. We were able to bring to the laboratory 23 such pairs for investigation and study, extensive study. And, we have published a few papers with this cohort. This is not correct -- this is one of the papers and here I'm using some of the data from two papers. The other one is in metabolism.

In the male, nine of these pairs that we were able to study in the lab, 44 years of age, the lean had a BMI of, a mean BMI of 22.7 and the obese had 28.8, about 5 percent fat difference. But, look at the implications? Incident, fasting incident almost --

DR. STAMPFER: Percent fat, is that percent in the diet or percent body composition?

DR. BOUCHARD: Percent body composition. Fasting incident is much elevated, almost double. Total cholesterol is higher, LDL cholesterol, triglyceride, I have a long list. In the two papers, you will see a long list of markers. I didn't want to get started. It's already crowded. I limited it to a few markers, but everything goes in the direction of an iatrogenic profile, just with a few kilograms of difference, kilograms of fat.

In the women, the same thing. The difference is even larger. BMI of 22 versus 30, and here again, we have all the negative effects, just with the addition of a few kilograms. So, I would, in closing, I would certainly be one of those who would say it may not be very critical for some people to, whether they have a diet which is 35, 38 or 40 percent of calories from fat, for some people, but for most individuals with the sedentary lifestyle that we have, it makes a big difference in terms of the risk of becoming obese, and, in turn, of being affected by the culpabilities of obesity.

I think I will stop there.

DR. GARZA: Alice?

DR. LICHTENSTEIN: Thank you for that incredible summary. Going back to the Stubbs data where the subjects were on a 60 percent, 40 percent and 20 percent fat diet, and in the free living situation, it looked like for the 20 percent and 40 percent fat diets, that the caloric intake was not all that different, it was really only in the 50 percent fat diet that the caloric intake or energy intake was higher? Was that actually the case? Because it's really the 20 to 40 percent that is sort of the variation that you tend to see among the U.S. population.

DR. BOUCHARD: In the free living?

DR. LICHTENSTEIN: Yes, free living?

DR. BOUCHARD: Well, I have not shown you the whole cumulative calories consumed, I know I have not shown you that. So, there is a difference between the three. It may be not as clear cut as in the seven-day study in the metabolic chamber, but there's a difference, graded, yes.

DR. GARZA: Scott?

DR. GRUNDY: I had two questions. First of all, it seems like the Rockefeller study is somewhat at odds with the Prentice study, because at 70 percent fat, there was no weight gain, but it seems like the Prentice would suggest that there should have been?

DR. BOUCHARD: But, the daily caloric intake was clamped, so it's just the composition.

DR. GRUNDY: Now, Prentice talks something about passive hyperphagia, and I think you might agree with that, that people that eat a high-fat diet, they eat more calories unawares, because the high caloric density of food. It's not that fat causes obesity, but it's because they consume more and they don't realize they're doing it and they put on extra pounds. Is that the basic hypothesis?

DR. BOUCHARD: That's a very clear summary of what I was trying to say.

DR. GRUNDY: Okay, the second question, I think you alluded to you wouldn't recommend loosening up the recommendation to have a higher percentage of calories. What do you think about the current recommendations that's been around for a long time, about 30 percent of calories is fat? Is that a reasonable recommendation?

DR. BOUCHARD: I personally, based on, especially based on the obesity issue, I feel comfortable with this recommendation.

DR. GARZA: Lesley?

DR. TINKER: Thank you very much. I have two questions. The first one, to make sure I understood something that you said about being weight stable at a higher fat diet potentially, because of the lipid oxidation, so does that imply there may be a little more resistance to the weight loss if one is on a higher fat diet and other datas, does it look at that?

DR. BOUCHARD: Well, let me take the first segment. It's a common observation that when people gain weight, they oxidize more grams of lipids per day. So, if they are consuming a high-fat diet, the only way for them to reach equilibrium between their grams of lipid consumed and the amount of oxidized, is to gain weight enough until that balance is achieved.

Now, there's some wobbling there, obviously, because you don't eat a fixed amount of lipids every day, it fluctuates. But, if you are generally a high-fat consumer, then either if you exercise to oxidize this extra fat, or you gain weight, then you become stable. Now, from there, I am not sure I understood the second segment of your question?

DR. TINKER: I was looking at that from a reverse. If there's this tendency to gain weight on that, what implications does that have for somebody eating a higher-fat diet if they're trying to lose weight and trying to cut calories, so kind of keep the calorie issue out of it, perhaps? But, if there's more resistance to weight loss, since one of the messages we're trying to encourage is to maintain or achieve an ideal, a healthy body weight?

DR. BOUCHARD: Okay, I think you could find some studies bearing on this issue. I cannot cite one off the top of my head here, but it will be very hard to generate negative energy balance, and therefore lose weight, on a high-fat diet, unless you do an enormous amount of exercise to compensate. If you think about the average weight-reducing program in which people will be advised to walk 30 minutes a day, if they are not on a low-fat diet, under these conditions, there is no way they're going to lose weight. So, they go hand in hand. It has to be if you are a high-fat consumer, there is almost no choice for you to lose weight. You have to go down to a low-fat diet, or a lower-fat diet, I should say.

DR. GARZA: Roland?

DR. WEINSIER Two questions. First, it's really a follow up on Lesley's question. From your presentation, my impression is that there are two consideration, one the theoretical and one the practical. From a theoretical standpoint, you've made the point that greater fat intake does not result immediate increase in fat oxidation as it would with carbohydrate, and you'd require an increased fat mass to increase that fat oxidation to counterbalance increased fat intake. So, from the theoretical standpoint, it sounds very convincing.

Then, when we look at the data, we see from a practical standpoint he feeds an isocaloric diet very different in composition and the weight stays basically the same with some day to day fluctuation. We look at the worldwide data, we can look at it, as you say, either way. There are positive correlations, negative correlations. The truth may be in between. So, are you trying to tell us that there are or are not compelling data, compelling enough to say that diet composition is a critical factor in weight control for these guidelines?

DR. BOUCHARD: I am trying to say it is in a sedentary population.

DR. WEINSIER In a sedentary population?

DR. BOUCHARD: Which we are, by and large, yes. And, I'm not considering that the population will be active if we were doing just about 30 minutes of walking a day. It would not fit the billing. The amount of grams of fat oxidized if you do that low-intensity exercise, 30 minutes a day, would not change the equation that much.

DR. WEINSIER And, the same question -- go ahead.

DR. BOUCHARD: So, I'm supportive of that view, that it matters.

DR. WEINSIER If I could -- excuse me?

DR. BOUCHARD: That it matters.

DR. WEINSIER Relates to one of the five things you mentioned in your introduction about the positive association between dietary fat and obesity. You mentioned ingestible fat substitutes associated with decreased body weight, and, in fact, one of the questions submitted by a focus group was, should we address in our guidelines the role of ingestible fat substitutes as playing an important role in helping the average person control his or her weight.

So, you didn't get back to addressing this, but what is your view? Is there evidence that fat substitutes do help in weight control?

DR. BOUCHARD: I don't think there is compelling evidence. There is evidence in the short term that it works, that you have an effect in the short term, over days, but there is also evidence that there is some compensation when the observations last for weeks and months. So, I don't think we have enough to reach a conclusion that would justify inserting it into guidelines, in my view.

DR. GARZA: Johanna?

DR. DWYER: Thank you. Thank you for an interesting presentation. I've got three questions. One was, I've heard Dr. Stubbs speak lately, and his focus seems to be on energy density and I'm not sure I got it all and I wondered if you could address that, because this is an issue that overshoots not only the fat guidance, but also the carbohydrate guidance and, of course, also the alcohol as well as whatever we say about protein.

So, that would be one issue. The second is the effect of alcohol on any of these regulatory issues and the third is this weight reduction issue. It seems to me, I remember in Dr. Pi-Suyner's report that the primary thing, of course, was energy intake on a low, a hypocaloric diet, for the weight loss. But then, I didn't remember much differences in the type of composition once that was over.

DR. BOUCHARD: That's a whole book.

(Laughter.)

DR. DWYER: You're an old friend, so I thought I could do it.

DR. BOUCHARD: The first one was the --

DR. DWYER: Energy density.

DR. BOUCHARD: -- density, yes. Quite clearly, the data are showing that there is, when you eat ad libitum, these differences, covert manipulation of diet, that the density is a key factor here. There are huge differences in calories consumed. So, there's a strong interaction between the two.

But, when you look at the active, inactive data in terms of -- not in terms of group of fat intake, but by calories, you don't see this clear pattern. You see it only when it is plotted versus fat in the diet, in the Stubbs data.

Now, they are certainly interacting and I would love to see a two-dimensional plot of these data, but it's based on -- it's experimental, it's metabolic chamber, energy expenditure. So, it's going to take a while, probably, before we have enough of those to separate them out.

The second question was?

DR. DWYER: The effect of alcohol intake at moderate levels of physical -- well, at sedentary levels of physical activity and intake. Not alcoholics, but the usual social drinking on weight?

DR. BOUCHARD: I know that you have a presentation coming up on this today or tomorrow. We have done a little bit of analysis in our group on the data of our family study and also the Canada survey data, when we were able to look at the calories consumed from, in our case, from three-day dietary records, and the activity level. And, in the aggregate, we see that we can almost put the same plateau, the same cell, the fat intake and the alcohol intake. It is as if alcohol was behaving as fat when it comes to energy balance.

So, again, if you -- activity can offset caloriewise, can offset the amount of calories coming from the alcohol, in terms of its impact on body mass or body fat content. But, it's epidemiological. I have no data from experimental material.

And, the third one?

DR. DWYER: Just back to this composition of weight reduction diets, once energy levels have been held constant and low? In other words, the basic thing is, are you eating yourself into a high caloric diet, and so it's relatively high in fat?

DR. BOUCHARD: Well, when I heard that in the committee led by Xavier Pi-Suyner, the HLB led to an HLB guidelines for the treatment and prevention of the morbidities. We reviewed the literature on the diets to see whether there was any material that could support the notion that portion of fat under isocaloric conditions would make a difference, and we could not reach a conclusion. There was not enough analyzed from two trials, if any. I'm not sure there were even any that would allow us to do that.

So, a pretty weak database.

DR. GARZA: Shiriki?

DR. KUMANYIKA: This point that you're making about the passive overconsumption, whatever, is critical to how we portray fat as a problem in weight control, so I want to make sure I understand what you mean by "covert" in those studies. Because, there could be a cognitive correction if people know that they're eating more fat, so that, you know, in the chamber study, you said it was covert, which I'm assuming is done in a way that the people would not be likely to perceive that this food had a higher density and therefore, would eat the same quantity of it. Whereas, in the free living adult, they might recognize in some foods and not in others that they're actually eating more and compensate by reducing quantity. Can you comment on that?

DR. BOUCHARD: Not much. The only comment I would have is that under both studies, the metabolic chamber and the free living, there was a covert manipulation of the fat content of the food that they had. It was similar in both studies. That's all I know. I don't have the actual technology that they used to do the manipulation. It's probably available, but I don't --

DR. KUMANYIKA: But, you're assuming the people didn't know, so it's a hidden fat, or fat that people wouldn't necessarily recognize, that would be more likely to cause them to over consume? If you assume that they actually were doing that covertly, not that people couldn't change their intake if they recognized that they were eating more calories.

DR. BOUCHARD: That is my understanding and the way I interpret their data, yes.

DR. GARZA: I'd like to shift your attention just a little bit to carbohydrates, getting back to Dr. Pi-Suyner's presentation earlier today. Do you feel that foods or diets of a high glycemic index play any role in the promotion of obesity among sedentary populations in the way that you've described for fat?

DR. BOUCHARD: My flight is leaving in ten minutes. It's a very controversial issue. Personally, no, I don't think it makes a big difference. I think it is more in the fat content, but I'm limiting my conclusions to obesity here. I think it's the fat content which is the main susceptible element in the diet, under free living, general conditions that we have in the Western world.

DR. GARZA: What if you were to broaden that to other conditions, like Type II diabetes? Is that what you were trying to do by limiting yourself to obesity?

DR. BOUCHARD: No, I was focusing, rather, on the extremes, for example, that we have seen in the Rockefeller diet, if we don't plan intake. Then, under these conditions, some of them you have 70 percent carbohydrate, then it may make a difference under these extreme conditions. But, it's so infrequent in our Western way of life that I don't believe it is the determining factor. It's more in the dietary fat.

DR. GARZA: Okay, Meir?

DR. STAMPFER: Long-term trials that manipulate fat composition haven't seemed to yield very large reductions in body fat. I'm wondering if you agree with that assessment and if you do, why that might be true?

DR. BOUCHARD: Yes, it is -- again, you can find both sides of the issue. You can find studies supporting both views. These are difficult studies, because we always have the compliance issue. It's true, also, from with the trials with physical activity, to reduce body weight. Compliance issue, and keeping the rest constant, so I'm not surprised.

But, we knew from experimental studies that it works in the predictable direction, but when people are free living and they make the other choices, then, of course, everything is possible and that's what I read into the long-term trials, everything is possible.

DR. GARZA: Alice?

DR. LICHTENSTEIN: There's something that I was struck that you said at the beginning, even though there is a lot of diversity, you can find almost any study to support your view. There doesn't seem to be, though, any evidence that fat restrictions to a certain extent would promote weight gain. It could sort of be constant, wouldn't go up, and I mean, one issue, I think, that we need to deal with with the American population is, there does seem to be an upward trend in body weight. And, one thing to do is to try to get people to lose weight, which is extremely difficult in the best situation.

And, the other is to stress more strategies to prevent weight gain. Is there any evidence that restricting fat would result in weight gain?

DR. BOUCHARD: Well, it depends on how you look at the data. If you take the population data, this is what they suggest. The U.S., you went from 40 percent to 33 percent, and you have a growing prevalence of obesity. But, that is, of course, totalling distorting what the experimental data are showing, both in animals and in humans. So, you can cite the study that you want to foster your conclusion that you want to promote. But, I think, by and large, this apparent discrepancy aside, I know of no study in which the confounders are taken properly into account, where going from a higher fat to a lower fat diet has led to an increase in weight. None.

DR. GARZA: Is the role of fat the same in all age groups related to obesity, or does it differ between the young and the very old?

DR. BOUCHARD: It probably changes subtlety maybe to a minor extent over time, because of the changes in metabolic rate, therefore, the oxidation of fat, activity level. So, that would impose some constraint on the effect that a given amount of fat would have on body composition, especially with aging, for example, or during growth. There will be different implications of a given amount of fat consumed, yes.

DR. GARZA: Dr. Dwyer?

DR. DWYER: Dr. Bochard, do you have any recommendations for levels of total fat, percent of calories, or however you want to phrase it, in people over, say, 70? And, do you have any suggestions as to optimal BMIs in those older Americans and Canadians?

DR. BOUCHARD: Well, I would favor staying with a clear message, and I'm of the same view as Xavier on this. Avoid zigzagging in the recommendations. I think it creates so much noise and leaves people, you know, without being able to understand what's going on and what is truly recommended. So, I feel pretty good about the 30 percent recommendation with the proportion that I've been proposing, that are commonly agreed upon. I would keep those for the older people, as well. Now, the -- if it on a proportion basis on the percentage of calories, then it's scaled automatically to volume of intake and to conditions of energy balance.

As for the level of BMI in older people and, let's say, we'll define older as anybody who is older than me.

(Laughter.)

DR. BOUCHARD: I would say that, I would not be tempted to intervene to try to alter BMI if it is below 30 and no culpabilities, especially in the older people, especially in the older people.

So, I would be fairly conservative there. At 70, 80 years of age, there is no culpabilities and if it is below 30, at that level of BMI, some other concerns come into the picture. It might be arthritic problems that may arise if weight is massively exceeding the norm, and other things like that. But, if there is nothing, I would be fairly conservative.

DR. GARZA: Okay, we are going to bring this to an end, so you get the last question.

DR. DECKELBAUM: Well, thank you very much for a very informative review. I'm wondering, in your review, which is the summary you presented here today, you focused on total fat. Would the quality of the fat influence some of these studies, and did you come across data which would give us some insight as to whether the quality of fat could also be affecting different results of these different studies?

DR. BOUCHARD: Yes, it's a very good question. I'm sure that the quality of the fat has not been taken into account in most of these studies, so far, especially the ones that I have cited. I don't think that it was available. And, there would be little to go in terms of impact on energy balance and weight regulation, very little to go. So, I don't think it should be a determining factor in making a recommendation in the context of weight regulation, because we have little data to go by.

DR. GARZA: Again, I wanted to thank you for a very informative morning. Thank you.

Then, we'll move on to Dr. Grundy, who will be discussing what we have referred to as the "fat guidelines."

DR. GRUNDY: I was very relieved to hear that Dr. Bochard was not recommending reducing BMI in people who are older than him, so that was good news.

(Laughter.)

DR. GRUNDY: What I'd like to do is briefly show you the proposed recommendation in terms of calorie percentages and then show you some of the possible wording that might go along with this, if you agree with it.

Here are our basic recommendations in the order that we thought they should be, with a major emphasis on the saturated fat, because we've heard a lot about obesity and we're all worried about obesity, but the scientific evidence is overwhelming that saturated fatty acids in the diet raise cholesterol levels and are highly correlated with coronary events. And, I think the evidence related to cholesterol to coronary disease has only gotten stronger and stronger in the last few years. And, the evidence that saturated fat raises cholesterol is very strong and is growing.

We still don't have a definitive diet heart trial that's showing that if you reduce saturated fatty acids in the diet of 100,000 people over ten years, that will reduce coronary events. But, the clinical trials that had been done are going in that direction, and I think the evidence is bolstered by a lot of circumstantial evidence to support reduction or a low intake of saturated fat of the diet in animal studies, epidemiology, limited clinical trial. So, I think the list goes on and on.

The dietary cholesterol recommendation is also based on a lot of data of the same type, showing that dietary cholesterol can raise the LDL cholesterol level and should also receive attention. And, this has been a long-term recommendation. And, then, the total fat recommendation of 30 percent, we've heard that discussed today at some length. It's basically the same recommendation we've had for quite awhile and we will propose that that not change.

Now, I think the major issue that we're faced with is how to say this, and in what order to say it, and what words we'll choose to say it. And, the current recommendation is to choose a diet low in fat, saturated fat and cholesterol, and our group, as we pointed out last time, has proposed some alternatives to that, which would change the emphasis to be more in the direction that we have listed here at the top. And, one proposal was that we just say, choose foods that are low in saturated fat and cholesterol, and not even bring in the total fat recommendation.

Now, our subgroup was, I think, moving in that direction at the time of the last presentation. However, there has been an undercurrent of interest in still keeping total fat in the picture. So, a couple of alternative recommendations were, number two, choose foods that are low, or a diet that is low in saturated fat, cholesterol and moderate in other fats. And, then, the third possibility would be, choose foods low in saturated fat and cholesterol and moderate in total fat. And, the term "moderate" in both these cases goes along with the 30 percent recommendation. We might call that a low-fat diet, to some extent. Since the total fat recommendation hasn't changed that much, the word -- you could call 30 percent low-fat, and it would be low, relative to current and past intakes.

But, with say differentiated from a very low-fat diet, let's say 20 percent fat, which has been advocated by some people, perhaps to introduce the word moderate might be a little better way to express that. So, those are the, where we stand, I think, on the wording, and we might have some discussion of that, or I could also go through the public comments, if you want me to, and deal with those, so that might expand the discussion somewhat.

Here are some of the suggestions made in the public comments. One was to drop cholesterol from the title and I've given you the reasons that we think that's not a good idea. To add "trans" to the title. I think since trans fatty acids, although they do raise cholesterol and have to be considered, the total intake in the American population, we feel, is not high enough to justify bringing them into prime time and giving them a term in the title. And, then, the total fat, some people recommended that like to keep the old recommendations. We gave you our argument in favor of modifying the title.

For children over two, someone suggested eliminating the three-year phased in reduction of fat and thought that we could just recommend it from age two. Food choices, the recommendation was made, we list foods, actually list foods that we should limit in the diet and list healthy foods. You see over here, here were some of the suggestions and the order over here of hamburgers, pizza and so forth.

Now, in the MCEP guidelines, we did have a table that Nancy Ernst played a big role in developing, which did have reduced intakes of certain foods and increased intakes or choose other foods, and that might be something to think about. We haven't gone into that much detail and it may be beyond the scope of this document to put in all these foods, but that's something to think about.

DR. WEINSIER Excuse me, Scott, would it be convenient for you to stand by the screen and point, there? I know you can see that, but we can't see.

DR. GRUNDY: I'm sorry.

DR. WEINSIER That may not do it either. Maybe if you could stand by the screen and just point at the screen, would that work?

DR. GRUNDY: Oh, just point at the screen? Okay, fine. Here were some of the foods that were --

(Laughter.)

DR. GRUNDY: No, I think that's partly a matter of space and may get into an argument, too, so we may just let the cholesterol education program provide that list and make that available to everyone, as well, in the country. I hope they will.

Now, what to say about eggs. The next question is recurrent and the sources of cholesterol and eggs have been given a bad name, because they are -- egg yolks are rich in cholesterol and how we say that the egg issue or how we talk about it is an important question that might need to be discussed. And, we don't want to single out eggs as the only source of cholesterol in the diet.

Saturated fat, it was also suggested that maybe instead of saying less than 10 percent, we say no more than 7 to 10 percent of calories. There is, perhaps, the trans words recommend putting a little more emphasis on the less than than on the 10 percent, if we could think about how to articulate that somewhere in the document, focus on grams of saturated fat. We actually do -- I think that if you look at what we've written, there is a table that does list the grams of saturated fat, but I think the feeling here was that maybe rather than percent of that, if we put a greater emphasis on grams, it might be something that's more applicable to people.

Trans fats, it was suggested that we expand the discussion and name foods that are rich in trans. That gets a little bit into the same issue here. Again, our emphasis has not been on trans fats, but on saturated fats. Although trans fats are important and they are in the document, we have not highlighted them for a special emphasis.

Relation of fat to cancer, it was suggested we discuss that and we could consider how to articulate that later. About total fat, some say eliminate it, some say to increase it or retain it, and we talked about the different possibilities that I mentioned a moment ago for wording.

Some thought we ought to get more emphasis to Omega-3 fatty acids and to define desirable amounts of the different kinds of unsaturated fatty acids. Actually, we have not paid much attention to that. We haven't gone into a great detail about Omega-9, Omega-3, Omega-6, and I think the feeling was that this is cutting it a little too thin. There's not a lot of agreement on that, and maybe we would just talk about unsaturated fat as a group. But, that might be discussed, whether Omega-3 deserves a special mention, although, certainly, it's been hard to get an agreement on what would be the recommended intake.

Finally, it was suggested that we emphasize how our restaurant foods are often high in fats, that's a fact, and they're high calorie all around. And, maybe we should say more about that.

It was suggested we define lean meats. I think that's a controversial area. I don't know whether we should get into that. One person thought we should recommend specifically, "Eat less red meat," but I don't think that relates to the fat recommendation. We do recommend cutting the fat off the meat, but the red part of the meat has some advantages and value, so that would have to be discussed in a broader context, I think, than the fat recommendation.

I think I can stop there and open the floor for discussion.

DR. GARZA: Any questions? Suzanne?

DR. GRUNDY: It's time for lunch, right?

(Laughter.)

DR. GARZA: Not for 20 minutes, then you can break.

DR. MURPHY: Well, I guess I'll lead off with some opinions, at least. I'm having trouble with the distinction between low and moderate, and I think consumers will also have that concern. So, I guess I have to say I favor some way of getting across a concept that really most fats should be low, but particularly saturated fats. And, so, I wonder if there's some way to word the guideline that choose foods that are low in fat, especially saturated fat and cholesterol? That would be my preferred wording.

And, while I have the podium or the speaker or whatever it is I have, I'm having trouble also with this statement that unsaturated fats are best, and I'd really propose we rethink that concept. Best for what would be what I think most consumers would ask? We also have a whole paragraph on trans fat in Box 11 that I think is, it seemed like you were also saying that we didn't really want to focus a lot on trans fat, so I would vote for that.

And, I think those are my main concerns as to where it stands now.

DR. GRUNDY: Well, let me respond to those. I think there are two points of view, and you expressed one point of view, that we should retain emphasis on total fat intake.

I think there's another point of view that there has been overemphasis on low fat and it has given the wrong message, and that a moderation of that message, particularly for unsaturated fats may be a wise thing to do. Now, we're not going to change the percentages, but I think that there is a feeling among some on this committee that pushing the low-fat concept has, to some extent, backfired, and may also not be scientifically valid.

So, to some extent, I'm in the school of thought on the moderate rather than the low fat, because I am concerned about singling out fat and putting overemphasis on fat for controlling calories. I think the presentation that was just made, which was about the relation of fat to obesity, many of the things in there, I could agree with, but I also feel that we have to have a balanced approach to keeping calories under control, both in carbohydrates and fat. So, I think the moderate, I think that point of view is represented here, as well. So, that's to be discussed. I think that's one of the main things we have to discuss.

DR. GARZA: Scott, can you amplify a bit how you think it's backfired for us to have emphasized lowering fat in the past? I mean, what are the health problems that we've created?

DR. GRUNDY: Well, I think what's happened is that, to some extent, industry has produced a whole series of products out there that are fat-free and I think they implied that you can eat as much of that as you want, because it's fat-free, and a lot of people have gone in that direction. That's one thing.

I think the other thing is, I think people feel that they don't have to be concerned about carbohydrate calories in terms of total caloric make up, and I think that's what this -- if you put too much emphasis on fat as the culprit, that's going to be one result of that. So, I'm just not sure that the low total fat message has accomplished what we wanted to accomplish, which is in the obesity area.

DR. GARZA: Am I correct, then, and you're saying that your concern is, the way that the guidelines have been interpreted or applied, not necessarily the information that was used to develop them was wrong?

DR. GRUNDY: Say that again?

DR. GARZA: That, in fact, your concern is the way the current recommendations or guidelines have been applied or interpreted, not that, in fact, a higher intake of polyunsaturated fats that are currently being consumed is going to have some health benefit?

DR. GRUNDY: Well, I think that the polyunsaturated fat intake is pretty much going to stay what it is. I don't think it's going to be reduced much. I think the sources of the fat are an important issue, and that's why it was said that the unsaturated fat in the form of oils is a better source than coming from animal fat.

So, the emphasis here is going to be to reduce the kinds of fat that are high in saturated fat, which will reduce, to some extent, monounsaturates in animal fats, but there is the possibility to replace those with vegetable oils. So that was the emphasis that was added, where the unsaturated fats are good.

DR. GARZA: So, the message that you're still advocating is limit fat intake, especially that of saturated fat and cholesterol? Or, are you saying, do not limit your fat intake?

DR. GRUNDY: Well, I think we are saying limit it. I think putting a moderation on it or limiting it is a good message, because it does, that relates to calories. And, I also think that there ought to be some similar wording for the other nutrients, as well. I guess that's it.

DR. GARZA: Alice?

DR. LICHTENSTEIN: There are data to indicate that if you decrease total fat without decreasing saturated fat, that you don't lower LDL cholesterol levels. And, then, in addition to the points that Scott made about justifying including a limit on total fat and what's happened with the food supply and all that, another point to be made is that it looks like in the U.S. diet that the decreases in total fat that we've observed have sort of been paralleled with the decrease in saturated fat, yet the message was total fat and saturated fat.

From the data, one would have wanted to see a disproportionately bigger decrease in the intake of saturated fat than total fat. But, since they seem to be tracking together without having a limit on total fat, notwithstanding the information on body weight, there's a concern that the saturated fat -- if the total fat started drifting up again, that the saturated fat would also start drifting up, and that's where the best data is with respect to plasma lipid levels and cardiovascular risk.

DR. GARZA: Rachel?

DR. JOHNSON: I have a couple of things. I think it's really important if all the committee members didn't get a chance to see this, because it just came early this week. The information provided by Madelyn Sigmund Grant from the University of Nevada at Reno, and she provided us with several published papers, and she highlights that free living consumers using reduced fat products have lower fat and saturated fat intakes and higher mean adequacy ratios, which is a measure of nutrient adequacy of micronutrients.

And, also, she highlights that of particular interest and contrary to popular belief, the use of reduced fat foods was not accompanied by a reduction in energy intake. And, I think these papers are critical to really add some empirical evidence behind the popular conception that people that use a lot of reduced-fat foods are substituting other foods and have higher energy intakes, because that's not what her data demonstrates.

And, then, I just had put my reviewer's hat on and had a couple of things. I think under the advice for children on page 22, it's critical that we mention the Catch study. We've cited the Strip -- we've provided two references for the Disk study and one for the Strip study.

DR. MURPHY: Twenty-two of what, Rachel?

DR. JOHNSON: What's that? I'm sorry, under Tab 10.

DR. MURPHY: Oh, sorry.

DR. JOHNSON: And, I can provide that reference. And, also, on page 20, it says, "The evidence is not strong enough to justify recommendations for lowering total dietary fat to prevent obesity and cancer in the U.S.," and I'd kind of like to add the caveat of yet. Is not yet strong enough, because I think as Dr. Dwyer has brought up in earlier deliberations, the Women's Health Initiative is still out there and we don't have results from that yet.

And, I also question whether 30 percent fat is really considered low. So, the implication, I think, here is that the recommendation that we're making is not strong in terms of the obesity and cancer area.

Then, I think that's it, but I'd like to see a reference for this statement that said, "Depending on the dietary changes made, one might decrease total fat intake by half and decrease saturated intake by less than one-fourth." Is that kind of what you were referring to, Alice, because that statement is not referenced?

DR. LICHTENSTEIN: Where is that statement?

DR. JOHNSON: It's on page 20, right in the middle of the first paragraph, but certainly the nationwide food consumption data shows as total fat goes down, saturated fat goes down. So, I don't know if this is just sort of a supposed -- certainly, anyone could design a diet that was reduced by half in total fat and only a quarter in saturated, but I'm not that sure that that's what happens, really, with usual consumption patterns. So, I'd like to see a reference for that statement.

DR. GARZA: Rachel, do you have any preference for the various choices that Scott has proposed, or another one?

DR. JOHNSON: No, I like Suzanne's.

DR. GARZA: Which was?

DR. JOHNSON: I weigh in with Suzanne's.

DR. MURPHY: Well, now, choose foods low in fat, especially saturated fat and cholesterol.

DR. GARZA: Yes, Lesley?

DR. TINKER: Thanks, my question is about the title have to do also with the total fat and one is a message-related and one is a science evidence-related. And, I think we've heard some of it before. But, if we took out the total fat, what message would we be sending to the consumers who are used to seeing it, and would there be a reaction that it didn't matter, as long as they kept the saturated fat and cholesterol high. And, of course, we don't know what the answer is to that.

And, then, on the science, just, is there enough evidence to support removing the message of total fat from the title? In line with that, I'd like either the title, "Choose foods that are low in saturated fat and cholesterol," and also the moderate fats -- "Choose a diet or foods that are low in saturated fats and cholesterol, and moderate in other fats," or the one that Suzanne proposes, of kind of flipping the order of the total fats.

DR. GRUNDY: I think that an important question about is whether we're going to have saturated fat out front and then whether, say, at the end, moderate or low in other fats, if you want to consider that. But, I think our subgroup felt strongly that the science put the emphasis on the saturated fat and not on the total fat, because that's the evidence for the relation to cardiovascular diseases is extremely strong. The evidence for relation to other diseases for total fat is not nearly as strong, so the emphasis should go where the evidence is.

DR. GARZA: You don't feel, Scott, I guess Suzanne was suggesting, adding especially, that adding "especially" to the saturated fat and cholesterol would achieve the emphasis that the working group wanted and yet meet the total fat concerns?

DR. GRUNDY: I think personally, I would rather see saturated, if you want to have low instead of moderate in other fats, if you wanted to say that, I think that could be debated. Personally, I feel that the saturated fat ought to be highlighted, because I think if the emphasis is on that, then that's where the greatest good would come, if we could reduce saturated fat.

DR. GARZA: Meir?

DR. STAMPFER: I strongly support the wording that's in the working draft, "Choose foods low in saturated fat and cholesterol." That's really where the science is, and if we retained or suggest that in addition to lowering saturated fat, you should also low other fat, basically we're recommending a reduction in intake of polys and monos, and I don't know of any scientific evidence to suggest that we're eating too much polys and monos. In fact, to the contrary, there's good evidence that there may not be enough consumption of polys, and I think that's part of the backfiring of the message, was that with the concept that fat is bad, people were reducing their total fat, not just by saturated fat, but also lowering polyunsaturated. Even in the new guidelines, we have some repeated references to choose low-fat salad dressings as a way of dealing with this, whereas that's really an important source of linolenic acid in our diet.

The paragraph that says unsaturated fats are best, I think is very strongly supported by the evidence. There's not much in our dietary guidelines that we have actual, randomized clinical trial data with clinical endpoints. But, that one is one where we do, and it's summarized in the chapter by Frank Saks that I sent around to the committee, where there are repeated, randomized trials, substituting polyunsaturated fat in place of saturated fat, and these lower clinical endpoints. So, I think that's very strong data that we can't ignore.

So, I think we should put the emphasis where the science is, lowering saturated fat, and not lead people to think that they're doing themselves good by cutting out polys.

DR. GARZA: Meir, can you put that in a context that would take into account both Tim Beyer's presentation and Dr. Bochard's presentation today? If our only concern, with fat would be cardiovascular disease, I could follow most of that argument. If I bring these other concerns to the table, then I no longer have this in context.

DR. STAMPFER: Well, for Tim Beyers, I think that's simple. He basically said that there was no relation --

DR. GARZA: He said that prostate cancer was one issue.

DR. STAMPFER: For total fat?

DR. DECKELBAUM: It was breast cancer, but he didn't relate to all other cancers.

DR. STAMPFER: Well, I'll have to go back and look at the transcript.

DR. GARZA: Looking at the totality of information, I mean, not many single groups have been tested, and then the whole obesity issue that we just heard.

DR. STAMPFER: Right, but we're down to 33 percent of calories from fat now. I think the goal is not to get that last 3 percent by lowering polys.

DR. GARZA: What would be the benefit of having the 3 percent polys?

DR. STAMPFER: Well, it would be the benefit of keeping poly with reduction of heart disease.

DR. LICHTENSTEIN: There would be an expense, though, of the 3 percent polys is not what's going to happen, because total and saturated fat tracks, so it's not that there would be, that that 3 percent would be just polys. It would probably be a mixture of polys and sats and that's the whole problem, that we want to get sats as low as possible. I don't think there's any evidence that if we get them down to 5 percent -- we'll probably all be better off, but that's not something that's particularly realistic.

But, keeping them at 11, 12 percent is probably not a good idea, so that's sort of the justification, because they're tracking so closely in the U.S. diet, not necessarily in other places. But, I also, as Scott indicated, that the subgroup did feel that it would be best to have saturated fat, cholesterol and then a message about total fat, and I think to address Suzanne's question of why not the total fat out front, I think we're justified in putting more emphasis on saturated fat, because what's happening is, if you look in the food supply, there are some foods that are now reduced fat. The saturated fats are coming out and that's terrific, but there seems to be a tremendous amount of emphasis on taking the unsaturated fat out, also, of various foods, and replacing it with carbohydrate. And, I don't necessarily think that that is good, especially for certain groups that are carb sensitive and their triglycerides go up and their HDL goes down.

So, although I wouldn't say let's take away any recommendation to limit total fat because of the issues related to bringing down saturated fat, I think the emphasis should really be on getting that saturated fat out, and that's why I think the order is particularly important.

DR. GARZA: Suzanne?

DR. MURPHY: My concern is less the order and I'm certainly not arguing that unsaturated fats are less desirable than other fats, certainly when you're talking about heart disease.

My concern was low for one and moderate for the other, and how that will be perceived, and is there some way to word the guidelines so we don't use different terms for those two? And, I thought especially saturated fat sort of got at that?

DR. GRUNDY: Well --

DR. MURPHY: Can I respond also to Meir?

DR. GRUNDY: Sure, yes.

DR. MURPHY: Then I'll turn it back over to you. Again, it's not that I disagree with the unsaturated fat message, it's this unsaturated fats are best for what? I don't think they're best for controlling your weight.

DR. GARZA: The best form of fat.

DR. MURPHY: Well, then let's clarify that a little bit, then. Better than saturated fats for cholesterol control or something.

DR. GARZA: Scott, do you want to respond before we go to Shiriki?

DR. GRUNDY: Well, I think that I would agree with Alice on the order. Now, as I said, we're going to be arguing whether to say low in total fat or not and whether Suzanne's suggestion that if we have kind of a mixed message on moderate and low and one thing in moderate and low, that's kind of confusing. That, I think, is worthy of debate.

But, also, I feel that the order does deserve to be changed, because the science strongly supports that. And, if you want to say that there's some evidence of total fat, lower total fat related to obesity and cancer and so forth, that certainly has been discussed today and deserves to be considered.

But, in order of the scientific evidence, the saturated fat deserves to be first and it also is something that can be done, which will produce a known definite benefit in the population. The others are possibilities.

DR. GARZA: Shiriki?

DR. KUMANYIKA: My comment relates to the fact that this guideline doesn't address calorie intake. I think that even I know how we got here with these guidelines. This division of fat intake from weight from sugar is not helping us with the problem of obesity.

So, this is actually almost indirectly, you know, a cholesterol guideline. It's latently addressing certain fat issues but not others. And, if total fat is related to the likelihood of overconsumption of calories, and then the same thing with sugar, I think we should include that or frame this guideline so that it addresses all of the issues for fat, while cross-referencing any other guidelines and not be framed so narrowly.

With that in mind, we have to say something about total fat as it contributed to total calories, however it can be worked in. It makes it more complicated, but I think we have to do that, because if you read this by itself, it misses the whole point that Claude was making in his presentation, for example, about fat intake.

DR. GARZA: Roland?

DR. WEINSIER If I were a fly on the wall, listening, I think I would hear that we're choosing poisons here, damned if you do, damned if you don't. Carbohydrates are bad and fats are bad. And, yet, this theme or what I hope will be a theme throughout the guidelines, will be the last statement in Scott's guidelines, "Eat plenty of grain products, vegetables and fruits."

So, my question is, is that the theme that we want to maintain throughout this booklet and reiterate it where appropriate throughout the guidelines? If so, is that a low-fat diet? And, if it is a low-fat diet, let's call it that. If it's not, let's not.

But, it seems to me that this ought to be appropriate for this type of dietary plan that we're recommending.

DR. GRUNDY: That's what we're talking about, is it a low-fat or moderate-fat diet? That's what we're talking about.

DR. WEINSIER So, is less than 30 percent, is that considered low?

DR. GARZA: I'm not sure.

DR. DWYER: Not in your circles, but in others.

(Laughter.)

MS. MEYERS: I think that most of us would consider a 30 percent calories a moderate diet. I think the previous guidelines, if you look at it, even though they're not together, have sent the message that 30 percent calories is low. I mean, that could be tested.

I think the consumer probably thinks 30 percent is low, which is something you'd have to deal with if you use moderate. It would need to be explained, because it would appear to be a changing of the message.

DR. GARZA: Johanna?

DR. DWYER: Scott, I share your view that saturated fat should be first, because they have primacy in terms of the evidence. And, I guess I have to listen to the experts on the cholesterol, but I do feel that we have to mention total fat and we need to mention low, because of what consumers now think, and I think they think 30 percent is low, but that can be tested.

And, the main reason I think that is, is because as it's written now, the guideline, I think, is a little unbalanced for some of the reasons that Dr. Kumanyika spoke to. The whole energy density issue is not developed there as much as it is in some of the other guidelines, and yet it has twice the value, gram per gram, that is twice as calorie dense. And, so, I think we would be sending the wrong message from the standpoint of continuity, and I'm not sure that I see that out there.

The other concern, again, I feel very strongly when a major government agency has one of the largest trials in the history of the United States in the field, with 1,000 investigators working to test the fat hypothesis against several chronic degenerative diseases in post-menopausal women, that it would be a mistake not to mention fat.

DR. GRUNDY: Would you be willing to just change the order of that first one, say "Low in saturated fat, cholesterol and fat," would you accept that?

DR. DWYER: Sure.

DR. GARZA: Alice?

DR. LICHTENSTEIN: I'm going to argue for moderate fat as 30 percent. I agree, I think at one point 30 percent was considered low fat and interpreted actually as low fat by the population. However, there are a lot of messages out there now really to the contrary. There's a whole line of food out there that's, what, 10 percent less, frozen entree line, and there's a lot of attention that was given to these very low-fat diets, a 10 percent or less, and it keeps cropping up again and again. And, although for certain individuals, that may be appropriate, highly motivated individuals, for the general population, I think if we use the word low-fat, we're not really referring to the kind of low-fat information that is evolving out there, and I think has really evolved, actually, to the point that you do see it in the supermarket frozen food shelves.

So, I think we also have to take into consideration that there's been new information over the past five years and potentially a redefinition of what moderate fat and low fat actually is.

DR. GARZA: Rachel?

DR. JOHNSON: Oh, I was just, I think of the MCEP guidelines, where the Type I diet is 30/10 and then the Type II is 20/7, isn't it?

DR. LICHTENSTEIN: 30/7.

DR. JOHNSON: Oh, so I was thinking that, I always think of 30 as moderate and 20 as low, but maybe nobody else thinks that way.

Also, I'd just like to add that I guess if we can't get the especially -- which I really liked Suzanne's suggestion, the especially, I would go with number two, only because I think that when you say low in saturated fats and cholesterol, and then moderate in total, I think consumers are very confused about what makes up total fat. So, you know, it's almost like saying saturated is not part of total, so I think it's very confusing. I guess number two would be better, if I had to pick something.

DR. GARZA: I think the consensus of the group is that we have to find an effective way of sending the message that reduction of saturated fat is a prime concern. Perhaps, Carole, as we go through focus groups, this is going to be one of the key questions, is to try several messages, see whether low is interpreted in the way that Linda suggested, or whether moderate is going to provide the information as Alice suggested. Whether if we sequence things by saying saturated fat, cholesterols and moderate in fat, would that mean that saturated fat and cholesterol don't count, because they're not part of total fat?

I mean, there are a number of issues that I don't know whether we can resolve, because they're perception, as opposed to science. I think we all would agree on the science part. It's now a, how do we then convey that science of limiting your fat intake to 30 percent and making sure that that limitation focuses primarily on a reduced-saturated fat and cholesterol intake? So, do you want to go to lunch or shall we continue the discussion?

DR. DWYER: One question.

DR. GARZA: That's fine. Alice?

DR. LICHTENSTEIN: I agree with you. I think it's something that really the focus groups need to resolve, however, there is evidence that very lot-fat diets, in a ceratin percent of the population, actually will have adverse effects. Individuals with Syndrome X, any type of abnormal glucose tolerance, and I guess I'm more and more concerned that we don't be perceived as, on a population-wide basis, recommending what, you know the 10 percent or less fat diet.

DR. GARZA: You said 30 percent.

DR. LICHTENSTEIN: Right, 30 percent is fine, but I think the issue is how is it, we really do need to understand what low versus moderate is.

DR. DWYER: Am I understanding that the group has agreed to 30 percent of calories from fat, regardless of what you call it? Like pornography in the Supreme Court, you don't know what it might be, but you know it when you see it?

The problem that I have is that this saying well, we'll wait and see what the focus group is, results are, is assuming that Washington operates on chronologic time and it doesn't, it operates on geologic. So, if something is in OMB, it's not going to come out for a long time and you won't have any focus group data.

So, either somebody else is going to have to do the focus -- I mean, it's easy to do. You just pay the Gallup people and they do it, or you -- you know, that's a council of nothing.

DR. GARZA: Well, I think that if we don't have that done by September, then we'll come to our own best-informed decision. But, I think we have agreement on the substance of the message, so that Scott and his group can continue working on the text.

DR. DWYER: Do we have agreement on the 30 percent?

DR. GARZA: That was the sense I had. The only other substantive issue was incorporating the total calorie message in a way that is less ambiguous than what we presently have, so that it isn't focused only on cardiovascular disease, but on obesity and some of the other health concerns.

But, those are the principal messages to the working group that I hear.

Richard?

DR. DECKELBAUM: I'd just like to ask the question whether the guidelines and the '95 guidelines are to be blamed for the increase in people choosing low-fat foods or fat-free foods? In other words, is that related to the guideline? What was the 1995 guideline, was it similar?

DR. GARZA: It is food labelling, the cholesterol, educational project. I mean, there are a number of messages that have gone out to the American public to reduce fat intake. I don't think that we could say it's the guideline.

DR. DECKELBAUM: So, I agree, and that's why I'm bringing it up, that I don't think we can blame the guideline as it exists with the word low in it, for the fat-free foods.

DR. GARZA: It's almost a semantic argument on low and moderate. It's a consumer issue, so let's leave it at that.

Are there any other substantive issues, though, that we want to make sure that the working group pays attention to, other than the ones I attempted to summarize?

DR. STAMPFER: Two points. On the 30 percent, I think the 30 percent is a reasonable target, but I think, you know, we can all understand there's no good scientific data that that's the optimal amount of fat.

DR. GARZA: Another suggestion?

DR. STAMPFER: No, no, I say it's a reasonable target, but I don't think we should overplay.

DR. GARZA: Let's not confuse the public.

DR. STAMPFER: But, I'm just wondering if the committee really does agree on the science, and so I pose a question to my colleagues. Do people believe that the American diet, the current American diet, is now too high in polys and monos? Should it be reduced from current levels? I don't think that it should, but I'm wondering if my colleagues disagree.

DR. GRUNDY: As I said awhile ago, the committee is split. There are certain people like Suzanne believes that we should reduce polys and monos in the diet, because they're too high. There are two different points of view expressed here, but I think the 30 percent does provide a common ground that we can all live with, and then now, I think we're dealing with the wording that goes along with that.

DR. GARZA: As I interpret the discussion, it's that it focuses around the total diet, much in the way Roland describes it. If we're looking at a diet that's high in fruits, vegetables and grains, that, in fact, that is consistent with, perhaps, decreasing the vegetable oil content of the diet. There are no benefits that I can see, when I asked the question, to keeping the fat at 33 percent or 34 percent or lowering it to 30, and assuming that you concentrate on the reduction of saturated fats. Anymore than any other major change, I guess, that we've discussed.

So, let's --

DR. DWYER: One thing. It seems to me in the Women's Health Initiative feasibility work, and I know Dr. Tinker is much more familiar than I was, that there was a document that was prepared at NIH about levels of polys. Now, that document, Dr. Stampfer, is probably seven or eight years old, so it may not be up to date, but I thought they had decided in that trial not to increase polys. You know, there was something.

DR. STAMPFER: Not to increase?

DR. DWYER: No, I think the issue was whether you could -- I think the issue was whether you could just let polys flow and there was some concern expressed in Maine. I think the argument was that old VA study, you know, where they gave the people the liquid oils, but there were some other data, and I never really --

DR. GARZA: That is related to the immune effects of an unbalanced M3 and six ratio, and the fact that we've got ratios now that are not five to one, but 30 to 51 and there are some people that feel that, in fact, that is creating other problems. And, we're not really dealing with that.

DR. LICHTENSTEIN: Also, there was some concern with cancer, because there had been animal data, and there's a recent med analysis last year. I'm showing that there is no supportive evidence in humans, and then there were also issues related to the susceptibility of LDL to oxidation. And, that is really just an open area right now, because the primate data we can actually look at, arterial walls don't support the susceptibility, in vitro susceptibility.

DR. GARZA: Okay.

DR. MURPHY: I do need to respond very briefly. It's not an issue of whether I think, on average, people need to reduce polys and monos. I don't think you could make a good case for that. But I think there are some people whose total fat, including their polys and monos, are too high.

But, my real concern is, this guideline should not give individuals or food processors the impression that it's okay to eat all you want of polys and monos, and that's what I want to avoid.

DR. GRUNDY: Well, that's a good point. We certainly don't want that. If you eat all you want, leading to weight gains, that's for sure.

DR. GARZA: I don't know about the rest of you, but I need my polys and monos. So, we will come back at 1:45. That's 30 minutes for lunch.

(Whereupon, at 1:15 p.m., the hearing was recessed, to reconvene at 1:53 p.m. this same day, Thursday, June 17, 1999.)


A F T E R N O O N   S E S S I O N

1:53 p.m.

DR. GARZA: We're going to be shifting, not because it is more logical, but we're trying to make sure that we go through the salt guideline before Dr. Dwyer leaves. So, we're going to switch to salt and then do weight right after that.

I've been assured it will be among the least controversial of all. This will be another ten-minute guideline, that's right. It's got to prove that academics will expand to fill any time slot that they're allowed, and go beyond. Dr. Kumanyika has changed jobs recently. She is now at the University of Pennsylvania.

DR. KUMANYIKA: Right, July 1. Okay, so we're going to talk about the sodium guideline now, and this is, does not reflect a consensus of the working group, so I'll make that disclaimer right away, because we haven't had a chance to go over some of the suggestions that I'm going to be making. But, I hope that after this meeting, we will be able to digest your comments and then revise the guideline. What's in your book does not substantially change from what was there before, except, as you'll see, the potassium box has been taken out.

I'm going to start with the public comments. And, then, I have some other overheads that incorporate working group issues and responses to the public comments. The issue at the title, there were two points made about the title. One is the salt versus sodium issue, which word do we mean? And, that's come up before.

And, then, in the public interest, suggested that we change moderate to low. So, we were on the opposite. So, they're suggesting change the title to, "Choose a diet low in salt or sodium," and the current wording is, "Moderate in salt or sodium." The issue whether we need both the word salt or sodium is not that simple, because salt and salty foods are not necessarily the major sources of sodium.

Also, as the testimony pointed out, what's on the food label, the comment from the Salt Institute, what's on the food label is sodium. So, if we were to use salt, right now, the consumer wouldn't have an easy way to implement the guidelines because when they look at a label, it says sodium, and they'd have to do some math in order to convert the sodium to salt.

So, those are the issues raised with the title and I do have a suggestion for some wording.

Then, there's the quantity recommendation or quantification, and that's to keep the 2,400 milligrams of sodium per day and to emphasize that consumers do not understand the word moderate. So, there was more than one comment to keep that, and then no comments on the summary sheet that have talked about changing the level. There are a couple that recommend eliminating the guideline, but if we have a guideline, the level that we have, 2,400, is the one that will probably go forward.

We have never come up with a good approach to setting a lower limit. That's still open, but 2,400 was mentioned as the upper limit.

A point that's come up in relation to the quantification is that it's harder for people who eat more calories to meet that level, but there is one level for the whole population. It has not been suggested that it be incremented for people at different calorie levels, so we have to deal with that.

Eliminate the guideline, a comment has been made, there are two comments suggesting that I think we're beyond that point. I mean, the issue is questioning whether there's enough science to support it. We're beyond that point and I'll go over briefly in a minute the reaffirmation of the evidence coming out of the NHLBI Workshop.

Age was applied setting advice to children, too, and we do have a little bit more information on that, so we'll try to make it clear how this applies to children. For blood pressure, the comment is really to elaborate on the evidence linking salt to blood pressure and the problems of higher than optimal blood pressures. So, this would suggest to make the blood pressure part of the guidelines stronger.

We earlier had discussions about de-emphasizing this as a specific risk factor guideline, so I don't think those -- I mean, blood pressure will certainly be mentioned, and maybe it can be made clearer.

Food choices, there are several issues mentioned about how to make this more practicable. Urge consumers to buy foods that are labelled "healthy," urge consumers to buy unprocessed foods, emphasize the high levels of sodium in many restaurant foods, encourage Americans to limit sodium and protein as an important means of conserving calcium stores.

Other food choice issues, the meal planning tips should encourage the use of sodium sparingly in a diet, should note that the highest sodium products are canned goods prepared with added salt and snack foods, and that animal products are higher in sodium than plant foods, unless salt is added.

Discourage the use of salt in cooking at the table, as opposed to the vague advice, use small amounts. So, these are comments from really one or two different, three different organizations altogether.

Under safety and emphasis, the issue -- I don't see the, oh, here it is -- the safety and emphasis issue was emphasized as safety and benefits of lower-salt diets and maintained the emphasis on sodium, not other nutrients. There's sort of a creep. If it becomes a blood pressure guideline, then you go from sodium to blood pressure and then you end up having the guideline describing other things that relate to blood pressure, which is how we got that potassium box sitting up in the front the last time. So, this is the recommendation, to maintain the emphasis on sodium in this particular guideline.

And, then, the DASH diet has been recommended. The DASH study, which was an eight-week intervention, had three grams of sodium fixed, because they weren't testing sodium intake, so they fixed it at three grams, and this comment is that the DASH diet should be recommended, since it showed that blood pressure could be lowered while having an intake of three grams per day.

The trial is testing three different levels of sodium in DASH II won't be ready in time for the deliberations of this committee. A DASH diet is a high fruit and vegetable dairy product diet and might be better recommended under the fruit and vegetable or dairy product guidelines, as one possibility.

So, those are the public comments, and then the association with calcium, just to mention the association of sodium intake with calcium, it's been in the guideline and it could be better emphasized, according to this comment.

So, I think the most efficient thing to do is to go on and go through the issues and the suggested responses and then have the discussion on those points, as we go along.

Next, this is the first page of the comments from the NHLBI Workshop that you remember was held in January to pull together the pros and cons under the various sides of the sodium issue. This has been written up. I believe all the committee got this by e-mail, so everybody has gotten this summary. I thought it was very well done. It mentioned the disputes that were, or the points that were raised contrary in the discussion, and will provide a good basis, I think, for what Dr. Garza had requested when we talked about the evidence, to also talk about what opposing views had been put forward.

Dr. Ernst tells me that this has been reviewed by the National High Blood Pressure Education Program and is being submitted with Drs. Chobanian and Hill as authors for publication, and may eventually be ratified by the members of the National High Blood Pressure Education Committee. But, we reported on this the last time, after that workshop, there wasn't a sense that there was any reason to eliminate the guideline and eliminating it would have certain policy implications. So, there's no science that says it's not a good idea. The question is how we put it, as Dr. Grundy said, how do we phrase it and how do we make it as practicable as possible for the consumer? And, that turns out to be a major issue for sodium.

So, here, it just mentions that this conference did look at all the issues, a relationship between sodium and blood pressure, individual differences in the blood pressure response to sodium intake and other nutrients, sodium and blood pressure in the young, clinical trials and clinical studies, observational studies in populations, sodium intake in relation to actually heart influence to cardiovascular disease and non-CVD conditions like asthma, and physiological effects of sodium intake, research needs and public policy considerations. So, that will stand as an updated -- not a consensus document, but a summary of the evidence with the opposing points noted.

Could I have the next one? So, the first issue, the title and eliminate guideline, which I put together, since we agreed before that we're not going to eliminate it, then it will stay and need to have a clear message and, I think, a clear relationship to the other guidelines. So, this is possible wording. Our writer/editor has suggested some wording related to salty foods, but that doesn't pick up the fact that some of the products we're recommending emphasis on in the dietary guidelines are major carriers of sodium intake. That is a dilemma, a problem that we should confront head on, rather than leaving it to the consumer to figure out, I think, so we should be talking about grain and cereal products and possibly canned vegetables. The only fruit that tends to be salted is tomato juice. Otherwise, fruit juices and fruits would be low in sodium, but the vegetables with sodium added could work.

So, maybe we can get some off-the-cuff reactions to this as possible wording. I've retained both sodium and salt, but put the emphasis for the salt on preparing foods and there's two addeds. I couldn't decide where to put the added, so you can see that both stayed, less added sodium added, but some language. And, I think added sodium works differently than added sugar, because we are talking about foods to which sodium is added, if we're referring to choosing foods there.

I'm also suggesting to include a box that lists the other dietary guidelines with highlights about how to moderate sodium intake in relation to those guidelines and what those implications of those guidelines are, including the food safety, and I have a picture of that in the next one.

But, first, does anybody have reactions to, this says, possible wording for a sodium guideline? The current wording is, "Choose a diet moderate in sodium and salt." Alice?

DR. LICHTENSTEIN: I can't figure out who to prepare foods with less salt. Right now, I have a hard time figuring out how to choose foods with less added sodium, because less relative to what? I mean, what I can think of, what I see in the supermarket would be vegetable, vegetable juice are labelled low sodium or low salt, and to me, that seems like those are my only two choices.

DR. KUMANYIKA: I mean, there are other labels and it may need to be changed to choose foods with low or moderate sodium. I think the idea to perhaps separate choosing foods that are labelled, so you can determine their sodium content and then where there's discretion, preparing foods that have less added salt, as a possible way to get at the sodium --

DR. LICHTENSTEIN: I agree with that. You just said off-the-cuff on that, and that's where my problem is.

DR. KUMANYIKA: So, "added sodium" may not work, right?

DR. LICHTENSTEIN: Well, "less added sodium" is the problem, because it's less relative to what, and do I have a choice?

DR. KUMANYIKA: Is that another product, right?

DR. LICHTENSTEIN: Yes.

DR. DWYER: Was this in our book?

DR. KUMANYIKA: No, what's in the book, I don't know if you had come in yet, what's in the book has not been revised, so in order for us to move ahead with discussion, I have put these things up and I made a disclaimer that it hadn't been discussed by the working group, so you won't be blamed for this.

DR. DWYER: I think it's important to maintain a guideline, but I don't agree with the added. I think it's verbose, confusing and again, I don't see the physiological meaning of that.

DR. KUMANYIKA: The physiological meaning?

DR. DWYER: Yes, I don't think it matters whether salt is added to something or not added.

DR. KUMANYIKA: We might be able to come back to it. I have another overhead that talks about the different sources of sodium, and so after we get these all out, maybe this will be guidance for Carole and we can figure out how to say it, so that it's not misleading in terms of where the sodium is coming from. Other reactions to this?

DR. WEINSIER Just real quick. If at all possible, I'm not sure what words you want to use, but in my mind, I'm envisioning a single statement and throughout, you can define what salt is or sodium is, but once it's defined, unless there's compelling reason to go back and forth, I would think it would be better to stick with one throughout.

DR. KUMANYIKA: Well, we need one statement, because both sodium and salt are in the current guidelines.

DR. WEINSIER Yes, I know it, so I'm thinking for the title, one statement, single statement, and identify which you want to focus on, the sodium or the salt, and then in the text, you can define both, but then choose the one that you want to stick with throughout. I'm not sure of the individual wording here, other than we have to get one term and one sentence.

DR. KUMANYIKA: Okay, and that might end up being a focus group issue whether -- I think the way we got with the sodium and the salt before was from consumers, sodium being technically the term we want, but consumers recognizing salt, so they end up being put together.

Okay, why don't we go into the --

DR. DWYER: Shiriki, just one -- the simpler we can keep those things, again, going back to the Ten Commandments, you know, if you could make a clear message like "Thou shalt not whatever," it's more straightforward, if we put it in a positive way, rather than a negative.

DR. KUMANYIKA: Okay, we're going to have to struggle with this and we may end up with the old wording. If we can't improve upon it, we may end up keeping it.

DR. MURPHY: You didn't mention an option that was mentioned in what I assume are Carol's comments. "Go easy on salty foods."

DR. KUMANYIKA: I mentioned it indirectly. It's that salty foods don't show up as a major source of sodium, so but if you focus on go easy on salty foods, and I have -- I don't have a cite of the sources of sodium, but the major sources of sodium, if you add them up, are products that are moderate in sodium content but are eaten in large quantities, so it's tied to calorie intake more closely than to specific salty foods which are also contributors, but not the highly salty foods that people recognize are the actual major determinants of overall sodium intake.

And, so, that's why I didn't consider that, because salty foods wouldn't be the right place to put that.

DR. DECKELBAUM: Shiriki, how about just, "Choose and prepare foods with less added sodium and salt." Work on the words later.

DR. KUMANYIKA: Somebody write that down. I think we can take all possibilities right now.

DR. DECKELBAUM: It's one sentence.

DR. KUMANYIKA: Choosing prepared --

DR. DECKELBAUM: Choose and prepare foods with --

DR. KUMANYIKA: Choose and prepare foods with --

DR. DECKELBAUM: -- less added sodium or salt or both. You can work on it, but it gets it both into one sentence.

DR. KUMANYIKA: Might work, okay.

DR. STAMPFER: I think I would favor the wording that was in the previous guideline, "Choose a diet moderate in salt and sodium," for a couple of reasons. One, it's not quite like sugar, where the concern is added versus natural sugar, because most of the sodium that we're eating is added one way or another, so we don't have to have that confusion. People think of adding salt to the diet, they're thinking of salting. And, salty foods, the reason that that may not work as well is that some foods that don't taste salty actually have a lot of sodium, for example, like a fast food milk shake can have as much as a gram, and it doesn't taste salty, but it's got a lot of sodium.

DR. DECKELBAUM: Meir, I'm not sure, and if someone knows more, correct me, but I don't think consumers realize how much of the salt they're getting from the foods they buy and they eat, processed foods, the produced foods, and that that is really their major source of sodium in a diet.

"Choose and prepare" means that they have a choice in picking foods, because most people don't realize that they can probably pick foods and that there are foods available. Different breads available that have less salt than others, and this will give a message that they have a choice in the mater.

DR. KUMANYIKA: I think the choose and prepare might work. That's a good suggestion. Let's go on in the issue of what consumers recognize is incorporated into another slide. This is the idea that I have, we can only relate it here to sodium, for how we should talk about the sodium guideline in relation to the other guidelines, and I also put the fat and sugar, because there are issues for sodium in relation to weight control. If you reduce your calories, you probably reduce your sodium intake.

Your fruit and vegetables, depending on the form, can be compatible with the lower-sodium diet. People have even questions about physical activity. Do they need more sodium if they start sweating more? So, I think that to give a guidance in sodium in a way that ticks through the other guidelines might be helpful and then we could, at the very end, pick up the safety issues, too, because there's the wholesomeness of foods issues with relation to sodium.

That's just a conceptual view of what I mean by relating the information to the other guidelines. The next one? This next one, the committee has a copy of, because I was pretty sure it would be too small for you to see and it's from the article by Linda Cleveland and Alyson, who is sitting here, you're an author on this paper. The reason I put this up, this is a paper that models the, takes the existing food patterns, in terms of servings from different food groups, and then models the recommended dietary pattern under assumptions of clamping the sodium intake at the recommended 2,400 milligram level, or letting the sodium float, to see what you come up with.

And, the reason that I wanted to bring this to your attention, and I have the whole article here and if need be, we can copy it, is that the implications, if you use these assumptions and I think the implications would be the same, even if you use a slightly different assumption, is that depending on whether you restrict or don't restrict the sodium, you get a different set of choices within the food group for the rest of the dietary guidelines. And, in some cases, you get a different number of servings.

Here, you get unrestricted sodium. You end up with 6.3 total servings of grain products and here it's 5.7, and there's some slight differences within the categories of which types of -- it's sort of ironic that when you restrict the sodium, you end up being able to eat more, you know, cakes and pies and cookies and candy and things that don't have any sodium in it, which kids' sodium reduction studies have figured out and they would meet their sodium goals by eating lollipops all the time.

And, for the fruit, there's more servings of fruit on the sodium-restricted pattern, but there are fewer servings of vegetables. So, to the extent that we're trying to increase the fruits selectively, which are underrepresented, then it's favorable, but not for the vegetables of 5.4 versus 4.4 servings of vegetables.

So, without going into the details on this, I wanted to use this to illustrate the fact that, indeed, if the sodium guideline influences the way the other dietary guidelines are met, and we should adjust that directly in the guidelines. I won't say more about that now, but like I say, I have the article if you want to see the details.

Okay, I looked through a book that showed up in the mail, I assumed, because we were on the committee, which summarizes a lot of the USDA analysis about consumer perceptions and food away from home and so forth. And, in reviewing that and also familiar with some other national data, there were some things that came out about consumer perceptions.

About 60 percent of consumers think that they're eating about the right amount of sodium, if you ask the question that way or at least women food preparers, I can't remember exactly which data said it was. Although, if you look at the healthy eating index scores, it's about 40 percent or less who are actually meeting the sodium goal, so that's an overestimation, I mean, what you said before, Richard, because people think that they're getting the right amount, because they're probably thinking, well, I don't use table salt or I don't use this, but they're getting more than they think.

Other things that have come out in the comments and the literature are that people may recognize, and very high recognition of sodium as related to blood pressure, but people might not think it applies to them. So, people could recognize, but then if they see a sentence that says, "Most Americans eat more salt than is good for them," or something, they may think, well, I'm not one of those Americans.

So, I wondered if we should use more direct terminology, "You may be eating more sodium than you think," instead of "Most Americans are eating more sodium than they realize," or "Most Americans eat too much salt," so I put that out for your reaction.

Other possible language, the sodium intake goal for healthy adults is about 2,400 milligrams per day, or something that makes a goal statement very clearly, and then, to figure out a way to address the calories. Eating more calories usually means eating more sodium. Young adults and men will have the hardest time meeting the sodium intake goal, and where that might lead will be to a text that says that people who eat more calories would have to give special emphasis to ways to moderate their sodium intake.

So, older women and, I mean, older people and women come much closer to meeting the goal with their usual calorie intake than would, especially teenage men have a high calorie intake and a high sodium intake going along with it.

Four, let me just see if I'm -- also, in general, on that last one, the awareness of the public is peaked after the National Heart, Lung and Blood Institute had a campaign to raise awareness about sodium intake, and it seems to be stable. So, this consumer perception issue is one that I thought relevant to if we would remove the guideline or weaken it, it might, indeed, say to people that they could eat more. So, this is important to hold the line, because even if we have a decreased intake, we've kept sodium intake from going up, at least as far as we can measure it.

Table salt intake may, the proportion of people using table salt may have gone up over the past few years from, you know, 40 percent to 43 percent, but most people still say they don't use table salt.

So, for the eating out, which is critical, I think, for all the guidelines and especially for sodium, to point out that a third, on average, Americans are eating a third of their calories away from home, this is from the USDA book, and foods eaten away from home are a major source of sodium, and the proportion of sodium intake has gone up, as food away from home has gone up proportionate to calories, from about 27 to about 34 percent.

So, I think this is the place to point out to consumers that, indeed, when they eat outside the home, they're probably going to get more sodium than they would if they were at home, and then, be positive by saying that it's actually easier to control your sodium intake in the foods you buy and prepare at home than it is when you're eating fast foods and restaurant foods and maybe have a box giving some more detail about that.

In the USDA materials, the restaurant sodium contribution is very high and fast foods are next, and school foods, on this particular graph, are lower. So, I do think we have something about consumption patterns that we can tell consumers and we can put it in language that is related to the behaviors that contribute to sodium intake.

DR. DWYER: Shiriki, on that, before you leave it, isn't what we want to do -- basically, a lot of people who eat away from home have to eat away from home? They're never going to eat at home. So, what are you going to do? One thing you can do is take stuff from home. Another thing you can do is to seek out prepared foods that are low in sodium that are "heart-healthy" or whatever you want to call them. And, the third thing is to choose things in restaurants that are already prepared, that are -- I guess what I'm getting at is, I think we should try to make it more actionable, if this goes in.

DR. KUMANYIKA: Right.

DR. DWYER: Because, otherwise, it's just telling people stay home, and you can't do that. You have to work.

DR. KUMANYIKA: Well, I had thought of these, you know, just to get us to the ideas of what things we might want to give or messages to discuss it, as the main points, and then the text would use some of the strategies, for example, that we recommend in intervention programs. So, each one of these would be like a main idea and then there would be some detail about, therefore, here are some tips, here are some things you can do if you'd like to minimize how much, you know, salt you're going to get unintentionally when you're eating out.

The other thing that I haven't said, but this is probably a good time to say it, is that a major role of the sodium guideline is to keep the pressure on the industry, including the catering industry, to make it possible to eat less salt. So, this kind of recommendation to a consumer, we could give the consumer some tips, but it also raises awareness and the catering industry might respond to it, also, even though the dietary guidelines are not making recommendations directly to industry. Can we write dietary guidelines for industry?

Okay, go to the next. Okay, these are other points that could be considered for the text if we wanted to strengthen it. Or, I mean, some of them are there in various forms, but I thought addressing head on the issue of enjoying food and sodium and flavor in something that at least approaches it for the consumer and tells them, we're not telling you to eat a bland diet.

There is some evidence that acceptability of foods that are moderate in sodium is pretty good and people could be given that information.

Convenience foods is one of the reasons people are using prepackaged foods that have sodium added, so I thought we could talk specifically about that. Not processed foods, but to pick on a type of food, but to say that, you know, for convenience, the food is prepared this way and it has things in it that limit your discretion in how much salt is added and give some advice on that. Nobody has time to cook from scratch. People probably don't even know what the term means anymore.

And, then, beverages would be a place to discuss water and the sodium content of beverages, and in general, the sodium content of beverages is not an issue, but it would be a place to discuss water intake and implications of sodium recommendations for beverage intake.

DR. DWYER: With the prepackaged foods, aren't there some now that are low in sodium? I thought there was a whole big trial of that, and I thought that DASH used convenience foods for part of its --

DR. KUMANYIKA: There are definitely some packaged foods that have less sodium, but on average, the same foods processed for convenience is a lot higher in sodium than if you hadn't processed it, you know, if you bought it, if buy it, bring it home from scratch. So, people should see that there's a trade off in the convenience foods and read labels. I mean, a lot of this is going to point to reading labels, because among the products available, they can see --

DR. DWYER: Yes, what I'm suggesting is making further distinctions. I'm well aware that there's a difference in the processed, but beyond that, it seems to me for the 21st Century, we need to go the next step and differentiate a little more, you know --

DR. KUMANYIKA: Regular versus special pack convenience foods?

DR. DWYER: No, keep within convenience foods.

DR. KUMANYIKA: Okay. There isn't an overwhelming amount of sodium-reduced food available right now, so we wouldn't want to frustrate people. There are some, but some that used to be there disappeared from the shelf. It doesn't -- it's not permanent.

DR. DWYER: Maybe one of the reasons it's not is because they didn't do --

DR. KUMANYIKA: Okay, I see where you're going.

DR. LICHTENSTEIN: I think there actually is more and more available, and they're usually side by side with little indication on the front of the package calling attention to it being low-sodium. People, I think, just need to be directed more to those products, and then I agree, they'll probably more likely stay on.

But, it is amazing that if you really look for them, that they are there now.

DR. KUMANYIKA: Well, some of it depends on the market, the supermarket, and the perceived --

DR. LICHTENSTEIN: The Northeast.

DR. KUMANYIKA: Right, and the better neighborhoods. I guarantee you, if you can find a supermarket in some lower-income neighborhoods, you're not going to find a lot of, any kind of special product down there, and they may be more expensive.

But, the other good news from the labels is that there's a solid reduction that's happened in a lot of products, which will be reflected ultimately in the labels, so it doesn't necessarily have to be a special package. If you point back to label reading, people can begin to realize that between two brands, there may be a difference, and they can pick the lower brand, because the labels are changing to catch up with some of the recommendations that are made.

So, I think the point is that when we're talking about convenience foods, to allow that there is some flexibility within that and to look for it.

Perhaps this should have come sooner. These are the different sources of salt, if you wanted to categorize in the diet. And, I thought, we really struggled with this iodine issue and I looked at what was said about it in a couple of the reports. I'm not sure what the box will say, but I think we should address iodine issues in a box. The literature is still kind of troubling. It doesn't make you totally comfortable with ignoring the issue, but there's not anything to say yet, so Dr. Dwyer is going to write this box for us.

(Laughter.)

DR. DWYER: No, she's not.

DR. KUMANYIKA: Or somebody at CDC. But, if we talk about sources of sodium and list off those different sources somewhere, it might give us a way to talk about the relative contributions of these different types of foods, even on a percentage basis of how much sodium is coming from these different sources, and there is an amount that's naturally occurring in foods, and then the added, some sodium added, and then the highly salted version.

The highly salted would also give us a chance to talk about certain ethnic foods which are very high in salt and soy sauce and some of the foods that you really can't make very low sodium versions, pick up on that issue.

Let's see what else is here. Okay, then the final topic, which will probably show up in the beginning of the guideline, in the standardized introduction, is what health rationale are we going to put? And, these are points that are made in the current guideline with the exception of, we haven't quantified, I don't believe, the high prevalence of high blood pressure, or a number of people in the population who could be concerned about ultimately developing high blood pressure. It tends to be down played sometimes with figures like 25 percent, but in the middle-aged and older adults, the prevalence of hypertension is actually quite high.

So, if it's positioned right, picking up on one of the comments, we might be able to make it clearer that a concern about ultimately developing high blood pressure affects the majority of the population. We mention that it's a major factor, it's not the major factor, and in that text, talk about the other factors, perhaps cross-referencing to other guidelines. And, then, there may be other help benefits of keeping your sodium intake near the goal, where you would mention the things that are in there now, calcium. I'm not sure what the consensus is on calcium bone loss. There are a couple of sites in the NHLBI summary that have linked the high sodium intake to bone loss, but there's more data looking into calcium, but they're less clear what the bone effects are.

And, anybody who's an expert on that can help us figure out what is the right version of that. If not, we'll be very vague and say, like we did last time, that the high sodium intake may relate to calcium.

DR. GRUNDY: Shiriki, on that second point, there's a little difference, I think, between the public health approach and its relation to sodium and the population and hypertension, per se. And, you know, I guess one view is that across the board raising of blood pressure, even in a population that might not have categorical hypertension, they would increase their risk for cardiovascular disease.

So, I think we have to be a little careful not to say the other five people that don't have categorical hypertension don't have to worry about it.

DR. KUMANYIKA: Don't have to worry about it, yeah.

DR. GRUNDY: I don't know exactly how to say that, but it's kind of an across the board effect.

DR. KUMANYIKA: Some way to mention that there are a lot of people who are potentially affected, but without implying that other people can forget about it.

DR. GRUNDY: Everybody has to be concerned about sodium.

DR. KUMANYIKA: And, the current wording may work, but just going through the comments and so forth, these were the points that I thought needed to be made in the health rationale, and what's not here is the major reference to the DASH diet and so forth, although I do think that if people are DASH aficionados, they can put that in the dairy and certain vegetables. I mean, it's a wonderful eight-week feeding study, is the way I feel about it, and I don't think that by itself it's a basis for making major policy recommendations. Not in the dietary guidelines, perhaps in the high blood pressure program guidelines, but not -- and it is compatible with the other guidelines, but I wouldn't put that in the sodium guideline, because I think it would confuse people.

So, those are the just talking points or discussion points about sodium, and if we could agree on these things as a general approach, if there's anything else that needs to be added, then I would want to work with Carol on getting this text drafted, and then have a conference call with the working group to flesh it out a little bit more, so that we could catch up with some of the other guidelines and where we are for the next meeting.

DR. TINKER: With the statement on five out of ten Americans have hypertension following right after the comment on the sodium, do we need to put something in there along the lines of not all hypertension is related to sodium intake?

DR. KUMANYIKA: What do you mean?

DR. TINKER: That if five out of ten Americans have hypertension, all of that is not necessarily related to sodium intake.

DR. KUMANYIKA: I'm not -- I don't think we would need to put that. The way the guideline is --

DR. TINKER: It's the paragraphs in the other guidelines that says other factors affect blood pressure and it talks about weight and those kinds of things.

DR. KUMANYIKA: Right, so it's a multifactorial condition, and we tend to, we try to go with the sodium sensitivity and didn't succeed in finding anything definitive that you could say to the public about who specifically is salt-sensitive. So, this argument hasn't really changed from you're probably eating more than you need, and on average, it increases your risk of developing blood pressure, along with other things, like weight and so forth.

DR. GRUNDY: Along that line, in a way, what we had talked about once was making the sodium section a gateway to hypertension prevention. Since hypertension is such an enormous problem in the country, if it could be a link to the need for the dietary prevention of hypertension, you'd want to keep that in in some way, wouldn't you?

DR. KUMANYIKA: I mean, I think the current wording suggests that now, and we hadn't agreed to change it. It would be a matter of whether we could strengthen it. A debate on prevention, there are only a few prevention studies. The longest is 36 months with a finding for systolic but not diastolic, and it's not the only strategy for prevention. So, how to say that anymore strongly than we've already said it, we don't have a lot of data to go much farther than we've already gone with saying, I don't think, if I'm getting your point.

DR. DWYER: Scott, maybe that concern -- I loved your little matrix, Shiriki, because I think it gets us a lot back toward some of the ideas Dr. Murphy talked about late last night. And, so, maybe some of the concerns that you expressed, Dr. Grundy, could be dealt with in that context, where everyone of the guidelines sort of interdigitates around these preventively oriented objectives.

The other two points I really had a question about, Shiriki, one was, what do we say about osteoporosis and sodium? And, then, the other is, I know that I've received the material and I went to that very good conference at Heart, Lung and Blood, as you did. But, I don't have a clear idea in my mind of what the actual differences are, nutrient-wise, between the pyramid, as we heard it explained by Dr. Shaw, and the DASH. It seems to me they're pretty much identical with the possible adjustments of the pyramid that will come with the new calcium AI. I would assume they'll be pretty much the same, or maybe I've missed something.

DR. KUMANYIKA: I think the DASH fruits and vegetables, the minimum servings is something like seven. It's higher than others and I'm sure there's been a comparison made. Do you know the quantitative differences?

DR. LICHTENSTEIN: Eight.

DR. KUMANYIKA: Eight, okay. Eight for fruits and vegetables where, for the same calorie level, that pyramid would recommend five?

DR. DWYER: But, it says at least five in the pyramid, doesn't it?

DR. LICHTENSTEIN: No, it says three to five vegetables and two to four fruits.

DR. DWYER: So, it's at least five. If it's eight --

DR. LICHTENSTEIN: That would be the max. So, it would be nine, actually, if you took the upper --

DR. KUMANYIKA: Working with the DASH, because I'm working on a study that uses the DASH diet, there is a sense that the DASH diet is more extreme than is being recommended in the pyramid. It goes over -- it puts more emphasis on fruits and vegetables than is currently being recommended at the same calorie level, but we could take that up at the next subcommittee.

DR. DWYER: Yes, I just need to know that, because it strikes me that it's pretty much the same if you go to the upper level of the pyramid.

DR. KUMANYIKA: But, the upper level is for a different calorie level. It's not, that range is only, that range is tied to calorie intake, which is one of the big confusions about the pyramid.

DR. GARZA: Any other questions? Are we ready to move on?

DR. MURPHY: I may have just forgotten, did we decide potassium was coming out entirely of this guideline?

DR. KUMANYIKA: Well, when, in the other factors that affect blood pressure, potassium would certainly be mentioned, but not necessarily highlighted there. Potassium could probably be highlighted in the fruit and vegetable section, where it makes more sense.

So, I think we definitely decided to take the box out.

DR. GARZA: Okay.

DR. KUMANYIKA: I think we got some good ideas and we will get you a beautiful text that everybody will agree with very soon.

DR. GARZA: Okay, we're going to move on to weight.

(Pause.)

DR. WEINSIER This section of the draft is Tab 9, page 15. Rather than going through the text, per se, what I'd like to do is, Joan, if you can show the first overhead, is first of all, just highlight the bullets that have been brought to our attention, not going into each one now, but addressing all of these as I go through.

What I've done is taken all the specific comments under each of these categories and built in, built them into my comments, which I'll give to you now. So, anyway, the area is message, individual responsibility, chronic disease, age specific focus food, physical activity, healthy weight, modified food weight chart are some of the issues. Go to the next one, if you would.

As an overview of foods involved, basically under working group, those are the names of the individuals that have helped on this. I'm not going to go through the steps taken at this point. Let's go onto the next overhead, if you would.

In terms of the recommended changes, again, this is an overview. This is like the table of contents, if you will slide it down just a hair. You can see the '95 version versus the 2,000 version. Basically, what I'm trying to point out is that there are not tremendous changes in terms of categories. What you'll see is, under title, the initial title in 1995 was balance the food you eat with physical activity, maintain or improve your weight, and tentatively, we're suggesting consideration of achieve and maintain a healthy body weight. I'll come back to that.

The title of the sections, we have the introduction, instead of having, "How to maintain your weight," and "Problems with excessive thinness" as separate ones, we've combined them under "Control your weight." "How to evaluate your body weight" is basically the same. Location of body weight is folded into this, so we have these three versus those four categories. "If you need to lose weight" is roughly the same. "Weight regulations," slightly different title but same advice for today. The same, and we do have several suggested changes under the boxes in the figures, which I'll go over.

So, in the next one, we'll take the top one, which is the title. The reason for a recommended change from balance of food you eat with physical activity, maintain or improve your weight, those are concerns expressed with regard to, first of all, the word balance, and second of all, the word improve. Regarding balance, the question has been raised, I guess this means that if I'm overweight, as long as I balance my food intake with my physical activity, I'm doing okay, and that's not the message we're trying to convey. Being overweight or obese is not okay, even if you were balanced at that level of overweight or obesity.

The second concern, the word improve was somewhat confusing. Improve your weight, does that mean increase your weight or decrease your weight? So, it was suggested that we consider this title, "Achieve and maintain a healthy body weight," and this was one of the comments written into us with a suggestion that we consider the title, "Achieve a healthy weight," and tentatively with opposing peer consideration, "Achieve and maintain a healthy body weight" as a possible title.

Go on to the next one, if you would. Then, under the various sections, first of all, it's just the introduction. Basically, it's pretty much the same as I've said here, except that we're emphasizing becoming overweight or obese increases your risk for various diseases perhaps a little bit more than before, but otherwise it's basically the same.

We've added a statement about the importance of a healthy lifestyle and long-term weight control, trying to keep coming back to this healthy lifestyle or healthy pattern of eating and physical activity, in the context of the major food groups, the plant-based food groups, that is, the grains and fruits and vegetables.

Comments that were sent in with regard to this section, that we should make sure that we address that obesity is the major contributor to chronic disease in America and I think we've done that here, and second of all, that we maintain the 1995 advice on maintaining a healthy weight. And, I think we've addressed that also by saying that we're not, we're suggesting that weight not only not increase, but if you're overweight or obese, that it come down.

So, we're not taking away from the fact that it's important not to gain weight, but also that for some people, they may need to lose weight. So, I think we've addressed the concerns.

The next one, where we combine two categories, that is, the two sections, one, "How to evaluate your body weight," and "The location of body fat." This section dealt with weight to hip ratio and we've combined them into one section for your consideration, and that's to simply call it "Evaluate your body weight." The justifications for the changes are as follows. In this, we discussed the relative importance of the degree as well as the distribution, both in the one section, of fatness in the same section, because of the complimentary contributions to health. We're trying to keep bringing these two together, that it's the shape, the apple-pear shape, so to speak, as well as the degree of overweight, that's important.

The new section recommends use of the waist circumference itself, rather than the waist relative to the hip measurement, as a more appropriate measure for assessing abdominal fat content, according to new research data that's been published since the 1995 version. This also brings it in line with the WHO recommendations as well as the NHLBI recommendations.

Reference to a healthy weight, and I italicized the word healthy, being comparable to the '95 version, so we're still using the word "healthy" weight as a reference point. The difference is the introduction of the BMI concept, where healthy BMI is 19 to 25, to be compatible with the WHO and NHLBI guidelines. So, keep this in mind, because there's some risk when you start bringing in something like a technical term such as "body mass index" that now we're trying to confuse the public by making the concept more difficult for them, when they finally figured out what a weight for height reference point is. And, yet, I think there's a lot of emphasis on using the BMI as a reference point for the public.

So, it's sort of a compromise. At what point do we introduce it and say it's time to go with it? It's like trying to go with the metric system. At what point do we make that change? I think the time is right and I'm proposing that we consider that.

A comment was written in with regard to this section, use a chart with separate gender and age information to avoid confusion. Use a chart with separate gender and age information to avoid confusion. Actually, according to the WHO and the NHLBI guidelines, there is no -- it's basically a unisex guideline now. And, it's not distinguished according to age among adults. There are distinctions with the younger ages, which we will have to take into consideration when we look at the BMI chart. But, otherwise, perhaps we just need to make it clear -- I think it's fairly clear now that if you're male or if you're female, that the same BMI is appropriate in terms of determining whether you're overweight and a health risk associated with that overweight.

Go on to the next one if you would. In this case, we brought down the second section from the the '95 guidelines, "How to maintain your weight," and "The problems with excessive thinness," which was a separate category before, and we wove them into one, "Control your weight." Our thinking is as follows, and maybe you can raise it up, if you would, Joan, so they can see.

The sections were combined since the issues of excessive thinness often arise in the context of and/or as a result of the desire to control the weight. That's our reason to put them together. The new section introduces a concept of relative roles to weight gain of modifiable attributes, i.e., individual food and physical activity choices versus the relatively unmodifiable attributes, i.e., our genetic make up. And, the statements to the effect that we've included this time, which was not there before, "Our genes affect our tendency to gain weight, however, genes don't determine if we stay lean or gain excess weight. Our food and physical activity choices do..."

So, anyway, it's our feeling, and this picked up on a recommendation that came to us, and that is, "Help individuals assume personal responsibility for his or her weight." In other words, make the point that there are some modifiable factors that we've got to focus on. Genes don't make the final decision about our body weight, our choices do.

Third bullet, as before, this section emphasizes long-term changes in dietary pattern, but now specifically states that to do this, plant foods, i.e., primarily fruits, vegetables, whole grains, I should say, should form the basis of our meals and snacks, and trying to keep coming back to this theme of the fruits, vegetables and whole grains.

The 1995 version emphasized eat less fat as a means of reducing energy intake. The new section clarifies that low-fat foods are not necessarily low in energy, so this is a pretty significant change from the 1995 guidelines. I hope it's for the better, but I think it's certainly congruous with the new information that we've heard, in part, presented today.

Now, some of the concerns -- let's see, oh, yes, and there was one other new section, "Defers discussion of physical activity to a separate guideline." Some of the comments that came in that are relevant to this section on control your weight, we should not say that soft drinks cause obesity. I don't remember the statement exactly, but it was to the effect that there's evidence that soft drinks, or the implication was that we're implying that soft drinks cause obesity.

We haven't addressed it in this section at all, but it was in Rachel's section, where she specifically says, or that section specifically says that soft drinks actually are associated with greater energy intake, am I not right? Wasn't that in Rachel's section on sugar intake? So, it's addressed, but we didn't address it in this section, unless you think we have to say something. Again, we didn't get into the soft drink issue.

A comment was made that the guidelines need to give practical guidance on use of low-fat foods and practical guidance on increasing physical activity, and also, practical guidance on how to maintain weight in a healthy range, and practical guidance on use of fat-modified, calorie-modified products. So, these were several comments that were made.

I don't disagree with any, and it's a balancing act, because even a whole textbook on how to control your eight would probably be insufficient to identify all the issues that a person needs to know about and address in controlling body weight. We do have, and I'll come back to a box which tries to highlight and supplement the text on these issues. But, I think anyone who reads it is going to say, this is insufficient. It didn't deal with all the issues, and I'm not sure that we're ever going to be able to do that.

Okay, let's go onto the next one. If we need, let's say, if you need to lose weight and then basically the same thing. If you need to lose weight, do so gradually. The 1995 version indicated a 5 to 10 percent weight loss may improve health and that a safe rate is generally one-half to one pound per week. The revised section follows the principles of the NHLBI guidelines. Aim to lose 10 percent of weight over approximately six months. Even a 5 to 15 percent weight loss is likely to improve health, however health is more likely to improve over long-term if the healthy weight is achieved and maintained.

So, we're trying to re-emphasize the importance of even a modest amount of weight loss can be beneficial healthwise, but that doesn't mean it stops there. That's an initial goal. Achieve it over the course of about six months, and then consider your next goal. That is, if you're still overweight, consider looking toward improving your weight for optimal health. I don't think there were any comments made about that section or comments made that would have modified our section further than that.

The next one, weight regulation in children, "Encourage healthy weight in children" is the current title. It's basically unchanged from the 1995, regarding the importance of children needing adequate food for growth and, number two, excessive energy intake and sedentary activity lead to obesity in childhood and adolescence.

The new section adds a statement regarding the severity of the problem during the past decade, i.e., the number of U.S. children who are overweight has more than doubled, based on growing data showing parents have a major impact on child's eating and physical activity patterns. This new section emphasizes the role of parents in setting an example for and sharing in, being involved in the child's diet and physical activities. So, this section has been expanded.

Some of the issues that were written in have a separate dietary guideline for children and adults, and we do, and also to decrease prevalence of obesity in youth, both food intake and physical activity need to be addressed, and we've dealt with those issues or will with the new section on physical activity.

The next one, "Advice for today," basically similar to the 1995 version. The revised section emphasizes the overarching dietary concept of the dietary guidelines, i.e., that the use of plant foods, particularly fruits, vegetables and it should say the whole grains, can facilitate weight control. And, the importance of physical activity is referred to in another, in the subsequent section.

Then, in the next one, we deal with some of the figures in the boxes. This was, still is a challenge, and I'd like your thoughts on it when we come back to it in just a minute. The figure in the 1995 version, I'll show you in just a second, I'll show in the next overhead, entitled, "Are you overweight?" And, we're suggesting one that's very similar, "Are you overweight?" But, considering adding BMIs. So, the committee recommends reference to the 1995 graphic for healthy weight for height, with the addition of BMI cut offs or an alternative graphic that gets that point across.

The graphic should encompass a range of healthy BMIs for the pediatric population, and that we haven't worked out yet. But, Rachel has given us information that we can use and we'll try to do that. So, the graphic that was used in the 1995 version, less these marks up here, and it's not very clear, you can raise it up some, but basically, you can look up your weight in pounds and your height in feet and inches, and it will tell you whether you're at healthy weight or moderate weight or severe overweight.

And, what we're thinking, if you can pull it down, Joan, just a little bit, is perhaps use a similar graphic that simply shows at the dividing lines between, let's say, an unhealthy low weight or an overweight status, that the healthy weight is defined as a BMI of 19 to 25, which coincides, by the way, exactly with what's in the 1995 guidelines.

Some changes might be that we have put in a BMI -- they have a 29 here, but we would change it to match the NHLBI guidelines of 30 as being, so between 25 and 30 would be overweight, and then we could consider having 35 and 40, so just extend this slightly, use the same sort of grading, whatever, change the title. This is healthy weight, the next one would be called overweight and the one after that would be called mild obesity. The next one would be called moderate obesity and the other one would be called extreme obesity, matching up with the NHLBI guidelines.

The reason why I'm thinking that it would be helpful to have the BMIs and the wording is because, and a couple of graphics ahead, I'll show you, we're trying to get some reference material for where the individual might fall. They can look up for my weight and height, I get this BMI, now, what kind of risk do I have? Is that bad, really bad, super bad. So, I'll come back to that in a second. But, just keep this in mind as one possibility.

Another possibility in the next one is rather than using that type of figure is just simply to use here's how to determine your BMI. Here's your height, here's your weight, and here's what your BMI is. If it's down here, it's overweight. If it's in this doubly graded area, you know, it's putting you in the obese category. So, this is another possibility and the third possibility suggested was just a variation on the theme, just laid out differently. Here's your BMI, I looked up my height, I looked up my weight at 164, let's say, I've got a BMI of 31. I guess I'm overweight, and then the reference point could be given down at the base of the table.

My bias right now is the first one I showed, but this is where we need some help and consumer input. Go on to the next one.

But, now, having looked up your BMI, can we estimate our risk of disease? So, this is a new box that we're suggesting, a new box intended to help consumers follow currently recommended steps for assessing weight status in relationship to health risks.

The committee is not sure if it's useful to use four categories of overweight or obesity in the table. Consumer input is desired, so let me show you what it looks like and then you can give us guidance in just a minute. This is what it might look like. This is basically a slight modification from the NHLBI guidelines that basically, if you're 18 years of age or older, you look up your BMI, perhaps in the figure, and you also check your waist circumference. So, if I happen to be a female, waist circumference of 34 and I looked at my BMI and it was in the overweight range, this is my risk for health problems related to excess weight. I don't know. Do people understand arrows? Is a relative one arrow to two arrows to three arrows to four arrows, is that telling us anything? I'm not positive. I'm perhaps used to looking at things this way, and this is what's presented in the NHLBI guidelines. But, whether this is going to be helpful to consumers is still an open question.

And, a suggestion was made, you've got too many categories here. Let's simplify it. Let's tell them they're underweight, healthy weight, overweight, maybe obese. Maybe coalesce these three and just say, once you get above 30, that's bad and not have so many different arrows, so many different boxes, and we're open to that suggestion, also.

And, then, the next box would be, if you've got lots of arrows, go on to the next one, should you lose weight? And, this is new, because this is not a box that was included in the previous guideline. The point that needs to be made is not everyone who is overweight needs to lose weight. So, if we had just the previous overview, and it showed an arrow showing an increased risk, the immediate response is, I've got to lose weight. But, that's not always true, so it needs to be clarified. To avoid the misleading impression that everyone must have a BMI less than 25, the new box provides guidelines based upon the degree of overweight and obesity, the fat distribution and the number of risk factors. The box cautions against weight loss for select populations such as pregnant women, certain psychiatric conditions, certain serious illnesses.

And, was there one more? Oh, and also, as in the previous version, "Decrease calorie intake from guidelines," we'll continue to have the slight modification of decreased calorie intake. Accumulating data indicate low-energy dense meals assist in control of energy intake, at least in the short-term. The findings are congruous with dietary guidelines, in that the basic three food groups are relatively low in energy density -- the fruits, the vegetables and the whole grains.

The new section provides a balanced emphasis, or at least we think it should provide a balanced emphasis, on controlling energy intake through one, control of energy density, and two, on control of portion sizes. So, these are both concepts that are important. As an example, in this particular box, we're stating things such as, "Get most of your calories from high-fiber plant foods, like fruits, vegetables, beans and whole grains. You can enjoy large amounts with little calorie intake." As well, "Control portion size. Many items sold as single servings actually provide two to three servings. Examples include 20 ounce containers of soda pop..."

So, anyway, we're trying in the middle of this balancing act to try to keep in mind that energy density may be important, but also, portion size is clearly important.

Just one more. Yes, the last one, in the previous guideline, there was a box dealing with caloric expenditure through physical activity and it's currently being proposed that because physical activity is important for many health reasons besides just energy balance and weight control, that it be considered as a separate guideline.

So, those were the issues that we've been dealing with and I think we've addressed at least the issues that have been brought in from some of the consumer focus groups. Any comments or questions? I'll leave it open to how you want to pursue that.

DR. LICHTENSTEIN: You've done a really comprehensive job. In response to one of your queries, where you had that table with those different arrows and everything, and the waist circumference and body mass index, I think that we're all used to looking at that, but as you indicated, maybe the general public isn't. It just seems that you've answered the question, if something like one of the first tables that you showed with slight modifications continued to be included, where the top of it reads, "Are you overweight?" That probably gives people, if they come into the category of yes, then that probably is enough to convince them that they should lose weight.

Then, if you want to give some loose guidance with respect to how big your waist is relative to your hips, that might be a little bit easier for people that aren't used to looking at tables the way we are.

DR. WEINSIER Let me ask you, if you looked at that table, are you saying, include the BMI or forget the BMI?

DR. LICHTENSTEIN: I would just include the graphic that's already in here with the modifications you suggested. I think that sort of answers the question. For most people, in general --

DR. WEINSIER Okay.

DR. LICHTENSTEIN: -- the issue is, should I lose weight or shouldn't I lose weight? Most people sort of know that already, but this is a very objective way of doing it.

I agree with you. I think people are going to BMI and it's appropriate to just initiate everybody into the world of BMI, but then, when you go on to start giving tips as to how to make these lifestyle changes and dietary changes, I think that's what's really important, that's what people really need the most.

DR. WEINSIER Do you think we can leave out that box with all the arrows?

DR. LICHTENSTEIN: I, personally, do.

DR. WEINSIER Okay. This is probably a major triage point, but do you think in the text we can clarify still that just because in the graphic you fall in an overweight category, that doesn't necessarily mean you have to lose weight or even should lose weight?

DR. LICHTENSTEIN: You could, but how many people would fall into -- like, what percent of the population fall into the overweight category, but really don't, besides football players?

DR. WEINSIER Oh, well, no, it's a lot of people fall into the overweight category --

DR. LICHTENSTEIN: But, don't need to lose weight?

DR. WEINSIER -- but don't have risk factors. Excuse me, no, I said it wrong, I mean, in the healthy weight, the 19 to 25. No, the overweight, the 25 to 30, but don't have an increased waist circumference, don't have, for example, any risk factors.

DR. LICHTENSTEIN: What percent of the population would that be referring to?

DR. WEINSIER You're probably talking about something on the order of less than 20 percent, I guess.

DR. LICHTENSTEIN: Again, is it more confusing? I mean, do you really end up seeing a lot of people who think they should be losing weight that really shouldn't be? I think that's, because that's what you want to try to avoid. And, if there are not a lot of people in that category, again, you're risking giving too much information and just getting people a little bit confused.

DR. WEINSIER Scott?

DR. GRUNDY: Two comments. I've been told for like 20 years that we shouldn't use the word healthy in guidelines, but I've also been told that bombing alone doesn't win wars, so I guess we have to rethink, you know, old ideas. But, I think that ought to be discussed for a minute. Can you be healthy if you don't have a healthy weight? I mean, does that imply, by using the word "healthy" that that's some implications about a person's overall health? I noticed they used it before, but that has been something that's questioned, whether you should use the word healthy as a goal or something, you know, rather than something more precise definition of weight?

DR. WEINSIER With the word healthy before the weight --

DR. GRUNDY: Yes.

DR. WEINSIER -- you're saying that doesn't do enough?

DR. GRUNDY: Well, I don't know, I'm just bringing that question, whether there's a problem with that word applied to any parameter, whether it's healthy or unhealthy?

DR. WEINSIER The NHLBI guidelines use the word normal.

DR. GRUNDY: Even normal is not acceptable, either, really.

DR. WEINSIER How do the others feel?

DR. GRUNDY: I don't know -- I'm not giving you an answer, I'm just raising that question.

DR. WEINSIER Yes, but now that you've raised it.

DR. GRUNDY: I don't have an immediate answer, but I know that before that, other groups have gone to great lengths to avoid using the word healthy.

The other question I had was about the 25 -- over 25 being overweight. It is true that the NIH guidelines did use 25 as the definition of overweight. But, when that was done, those were clinical guidelines and you know, we got a lot of flack for that and we kind of wiggled our way out of that by saying these are for patients and that patients are at risk and these are people seen in the clinical setting, and that's kind of an area where you begin to look for risk factors. And, we turned it into a clinical guideline, which it was already, and we say that that may not hold for the general population.

Now, I think if we make a decision that it does hold for the general population, that would not be just adopting the NIH guidelines, which was for clinical purposes, but would actually be something that we would consciously say that we're ready to say this for the general population, realizing that probably about 75 percent of adults are above a BMI of 25. I mean, that's the number I've seen. I don't know whether that's correct, but it is certainly something to think about is how far down is it in the current population distribution are you going to define overweight?

DR. WEINSIER Well, it gets back in my mind to Alice's point and that is, if you look up in the table or this figure and you see, well, I'm in the overweight category, I guess I need to do something about it. Well, the only thing I can envision doing about it is to lose weight. And, yet, that may not be the right message, because I'm not sure that we can say that and the guidelines don't say that everyone in the overweight category, unless you have, you know, either increased waist circumference or --

DR. GRUNDY: I guess my question is, are we ready to say that the 25 is the cut point for overweight for the general population, unrelated to clinical considerations? I mean, if we are, I'm not against it. I'm not opposing it, I'm just saying that it is a step beyond what the NIH guidelines are. It's not just adopting --

DR. WEINSIER Well, remember it was in the 1995 guidelines, too, before the NHLBI guidelines, that the overweight was classified as a BMI greater than 25. So, Bill Deets and his group had already addressed this.

DR. GRUNDY: You mean, it's not making a change from where we were before?

DR. WEINSIER We're not making a change.

DR. GRUNDY: Yeah, okay.

DR. WEINSIER The concern I have is, I don't want to make for a more psychotic population in terms of, just because I fall in the overweight range, it's time to panic, because we're talking about 52 percent of the population.

DR. GRUNDY: Right, I guess that's the same question I'm raising.

DR. WEINSIER So, how do we get the message across, you know, without over addressing or raising overly the concern?

DR. GARZA: Shiriki?

DR. KUMANYIKA: I was going to comment on what I thought was the intent of the NHLBI guidelines, but I'll add to what Scott said. I think that 25 is appropriate from before, and also because World Health Organization has bought into that, so that's being accepted globally as a definition for population.

But, the message that's not here is the weight gain prevention message that was a lot of the intent of that 25 to 30 category, was for people to recognize that they're in that window where they might already have risk factors, but if not, with the trajectory of gaining, you know, half a pound a year or something, this is when they should start trying to hold the line.

And, we might be able to work that in there more clearly than it's there now.

DR. GARZA: I think that's a very important point. And, as I recall, it leads to the earlier discussions that the last time we did this, that was one of the selling points. That if we try to get people to lose weight when they got much above 25, it was going to be very difficult, especially given the rate for weight loss. And, so, working in language that clearly says, you know, we don't think, don't necessarily want to make you psychotic, but on the other hand, if you don't start paying attention, then there may be good reason for you to become neurotic.

DR. DWYER: I agree wholeheartedly, and I think in some of the other guidance, there's something about more than one BMI unit or something is a time to think. It seems to me that it would be nice, Roland, if we could have tables that made it possible for everybody to find their BMI, not just those above a certain cut off. And, I think some of the illustrations that you showed had that.

DR. WEINSIER Did the first one do that?

DR. DWYER: Yes, I think so.

DR. WEINSIER I think all of them should have. Extremes, unless they're six foot four.

DR. DWYER: It would be nice if we could get everybody to know it. The other thing that might be nice, and I don't know if it's in there, I didn't see it when I read it, was the little conversion from feet to inches, so that you get that in people's minds.

And, finally, on that table that Dr. Lichtenstein mentioned, it seems to me if the table stays, that it would be very helpful to have the risk of disease that you were talking about. In other words, as I understand that, infertility risks start at a different level than, say, the orthopedic risks associated with trying to carve through several hundred pounds of fat to do a gallbladder operation or something. That the risks are quite different. So, it would be helpful, I guess I would like to see the diseases in there, if that's done.

And, also, the modification, at least a little asterisk like the asterisk in the first obesity in the National Conference on Obesity guidelines on all of this, where they mentioned the modifying effects of smoking, high blood glucose, physical activity, which I think is in there, and I think there's one other, isn't there, high blood pressure? So, that, again, we interdigitate between these different issues.

And, finally --

DR. WEINSIER Just let me be sure I understand that one. You're saying that we need to highlight that obesity tends to be part of a syndrome, hypertension --

DR. DWYER: No.

DR. WEINSIER Or, what are you saying?

DR. DWYER: Any given BMI level, any given BMI and waist ratio, or waist level, any given level of those two things, the additional factors increase risk, and I believe it's exponentially. It's not just arithmetically.

DR. WEINSIER Right.

DR. DWYER: So, just those things, and then somehow, if we could get in the idea -- I don't know if this is the right place, but a plant-rich diet, lightly processed foods and so forth, might be useful.

Also, what about the elderly? Is there anything you're going to say about them?

DR. WEINSIER It should be in there. Shiriki added some, I think, nice language in here. But I can't put my finger on it right this second.

But, basically, the point is being made that the older adult population also has to have concern about overweight. That they're not immune from the importance of maintaining a healthy body weight.

DR. DWYER: Yeah. The question is what do you do about losing if you got a person 300 pounds in a nursing home?

DR. KUMANYIKA: We shouldn't be covering those people I don't think.

DR. WEINSIER All right. But, I think Johanna's making an important point that we got hung up in. Where is this clinical versus where is this, you know, public health oriented? Because we were getting very clinical in the beginning, and we've had to back way off because we got into a lot of stuff in talking about and had to back from that.

Meir, did you have a question?

DR. STAMPFER: Yeah. I thought this was really good. Just a couple little points.

One, on the elderly -- well, one aspect that I liked in particular, was that to avoid gaining weight within the category. That's a very nice point to emphasize. And relevant to that, for the elderly, one of the common things that happens is with loss of lean body mass, you get more fat, but you don't get -- you don't increase your BMI. And I'm not sure -- I just raise this as a question of whether that could be worked in somehow.

One way possibly to do that would be to talk about avoiding waist circumference increases because that's almost always fat increase. And that's usually where it shows up when you have a constant BMI with an increasing adipose.

DR. GARZA: Scott?

DR. GRUNDY: I think that emphasis on waist circumference is very important and we ought to shift more in that direction.

One of the things you said about -- one of the figures you had about increasing risk with increasing BMI, that doesn't necessarily hold for all risk factors. And certainly for a risk for diabetes, it goes up in the manner you described. For others -- some other risk factors like cholesterol, it goes up more when you have mild obesity, and then it sort of flattens out. And I'm not sure about blood pressure. But, it might leave the impression that mild degrees of overweight, you know, really aren't too bad and only when you really get to high levels, does it really kick in.

And I don't that's necessarily a good message because moderate overweight I think is where most of the increment occurs. And then, there, it sort of flattens out a little bit a higher levels. So, it's hard to do a systematic analysis of whether your absolute risk goes up with increasing weight, but it's not necessary true for all the risk factors.

DR. WEINSIER Yeah. I mean, you're absolutely right. It's not going to be true with all the risk factors, but I've looked at the patterns for the cholesterol there's going to be an exception because it's not that well correlated, as you know, with BMI or percent body fat. Triglycerides, insulin resistance, risk of developing diabetes, hypertension track fairly well. I mean, I'm sure the cut-offs are going to be a little bit different, you put -- but the pattern, as I recall, is quite similar for those. But, it's not going to be true for all of them. Your risk of cancer may be very different. So, what are you --

DR. GRUNDY: Well, I guess what I'm saying is I think the majority of the population's in the overweight category. And if you just give them a mild increment in risk, you may be underestimating or giving a message that it's not as important for risk factors as it really is. I guess that's what I'm trying to say.

DR. WEINSIER So, are you in a sense agreeing with Alice that maybe this box we're talking about the arrows and increased risk may be better not to have it, then to have it?

DR. GRUNDY: I might not have it so quantitative as you've got it there. I mean, to state that it goes up with increasing risk in general goes up, that's okay, but I don't think we ought to downplay the risk associated with mild overweight.

DR. GARZA: Suzanne?

DR. MURPHY: I just am not sure where we stand on Box 1 Table to Estimate Your Body Mass Index. Are we going to leave that in? And if so, I would like to argue against it. I think it's too detailed for this publication.

DR. WEINSIER Remind mind me again.

DR. MURPHY: Table to Estimate Your Body Mass Index.

DR. WEINSIER Okay. Are you talking about the figure that we're proposing?

DR. MURPHY: Well, I don't know. On mine, it's called Box Number 1. And it's how to calculate your BMI from your height and weight. And I can't tell if you're suggesting that be in addition to this.

DR. WEINSIER Oh, no, no. Yeah, I think there was some confusion when we were preparing this version. We're not hardened in our categories to the point where we're saying this is one that should be included. In fact, I don't even know why this one got put in versus the others. I don't know.

Regardless of the reason, we showed the options of the figure with the additions of the BMIs, the old one with the addition of BMIs, and we showed this as one option and one other.

DR. MURPHY: Okay.

DR. WEINSIER So, this, I guess, was the only one that happened to be put in here.

DR. MURPHY: I hold for this one. I wasn't sure if you were putting in both, but I thought think that would be too much.

DR. WEINSIER No, we're not proposing more than one.

DR. MURPHY: Okay, good.

DR. WEINSIER We're asking for input. So, that's fine. I think they're agreeing with others.

DR. MURPHY: Just to follow that with a philosophical comment, I guess. One of the things I like about separating physical activity and the weight guidelines is that I've always thought physical activity is the real key. And that's a message we can reach consumers with. Trying to get to people -- continuing to beat people over the head to lose weight has never worked in the past, and I think is hardly ever going to work in the future.

So, all the discussion about, you know, trying to not gain weight, I'm absolutely for, and I like that focus in this guideline. But let's try to keep it real brief. And anything that isn't really crucial, I would vote to omit from this guideline.

And let's beef up the physical activity one with the message that I think has a chance to succeed.

DR. WEINSIER Well, you're raising an important point. And that's one that gets back to the length. I mean, this section has grown, and Carol Suitor has said, "cut, cut, cut," and we've been trying to. And yet, as we talk, you can hear that there are a number of voices saying, "You need to address this group, this type of co-morbidity." It's a real balancing act. It's long.

DR. GARZA: Meir:

DR. STAMPFER: Just to break the rules for a quick second, first in word smithing. I think we should try to avoid things like "mild" and "moderate" for categories that we think aren't so good. We've been using the term "moderate" as something that's okay. And so, I think moderate overweight, it's just -- you're overweight, you're very overweight, extremely overweight.

DR. DECKELBAUM: The only other two issues, is the words used by the NIH guidelines for the --

DR. GRUNDY: No. No, they're not. I don't think.

DR. DECKELBAUM: They relate in part to that?

DR. WEINSIER Yeah, these words are taken from the NIHLBA guidelines.

DR. GRUNDY: No, I don't think.

DR. WEINSIER You're pretty sure?

DR. GRUNDY: They have one, two three. They have categories of obesity, one, two and three.

DR. WEINSIER Yeah, I think you're right. I think you're right.

DR. GARZA: The only other issues that we ought to think about, and they both relate to the point that Suzanne just made in terms of with any weight gain other than weight loss is what we used to call yo-yo dieting. In terms of -- has the health risks of losing and gaining weight through repeated dieting grown in any way that it would change our advice to individuals or our warning that it's much more important try not to gain weight and lose weight and then gain it and try to lose it again and regain it? We don't address that at all.

DR. WEINSIER No, we don't. I mean, the data has been reviewed recently by the Obesity Task Force at NHOBI and publication followed that. And I think regarding the non-psychological issues, the only psychologic issues that the data are pretty clear that weight cycling should not be considered having adverse effects, either on energy metabolism, through metabolism or physical health.

So, I think we're fairly comfortable with that current status. The question is, do we put something in here to that affect, et cetera, et cetera? To have lost and regained and never to have lost at all sort of thing.

DR. GARZA: And lastly, whether pregnancy still represents a risk in terms of permanent weight gain following the pregnancy. The last time I saw the data, it really looked equivocal. I mean, it wasn't very convincing.

Then, do you want add something telling women that that's a particularly critical period in terms of their weight history, that they try to mobilize that weight gain immediately after pregnancy because of the attendant risks?

DR. LICHTENSTEIN: You put in a pitch for breastfeeding.

DR. WEINSIER Without adding any length, of course.

DR. GARZA: There is some data now that if it's past six months, it's the short term that doesn't really help.

Carol?

MS. DAVIS: I just want to say something about the focus group now, Roland. I'm going to need some clarification on what table we're going to be testing because right now we've got the one that Suzanne, and it seems like you all want out, to be tested, the BMI one. If we're going to make a modification in the one that's in the --

DR. WEINSIER Well, I thought we were testing all three that we had --

MS. DAVIS: No.

DR. WEINSIER No?

MS. DAVIS: No, we weren't.

DR. WEINSIER Okay, now I remember.

MS. DAVIS: You were testing the one that's in 95, plus the BMI, the one that you said you didn't want --

DR. WEINSIER Right, exactly. Those two.

MS. DAVIS: If we could get that clarified.

DR. WEINSIER That is, is there any reason not to go ahead and do that because this is a bias of this committee?

MS. DAVIS: If we absolutely don't want to use it, I don't see any sense in testing it. You know, you just said you didn't want to use it.

DR. MURPHY: That's one member's view. I wouldn't test it. I wouldn't bother.

MS. DAVIS: I mean, maybe we could do a modification of the one the way it was and then the one with the thing on the top like you're suggesting.

DR. WEINSIER I mean, it passed the 1995 guidelines. So, evidently -- I don't know what testing it went through then, but it was felt to be useful. So presume that it was useful then and all we're trying to do is say, is it useful? And it could be a little bit more so with the addition of the BMIs. If the people around the table are comfortable with that, then maybe we shouldn't go through the focus group testing.

Bert, does that seem reasonable?

DR. GARZA: Yep.

DR. WEINSIER Okay. So, is there anyone not comfortable with the suggestion that we go with the 1995 version, perhaps with some modification that includes the BMI?

MS. DAVIS: I mean, we could still put it in there, but I just don't want to test this one if you don't want the one that --

DR. WEINSIER No, I agree.

DR. GARZA: I think that's a consensus. Don't test this one and just test the other one to modifications.

There were some questions here before we move to them.

DR. DECKELBAUM: Everything that's here, I'm not going to have enough time to exercise, so there's got to be -- it's sort of dense the way it's written, and I

think -- and also, going through it, there's a redundancy with other sections and other guidelines that you can look at in terms of cutting down. But I think it would really help to try to get more of it in point form or bullet form or dash forms so that you just have no messages.

I know this was a draft where you responded to a lot of the suggestions, but now I think it could be made more reader-friendly or user-friendly. I can help on that because I'm outside and I could volunteer to sort of go through it and --

DR. WEINSIER Yeah. If you want to e-mail some suggestions to us, that'd be great.

DR. GARZA: Suzanne?

DR. MURPHY: One comment on what's in here several times now, that plant-based foods are the key to successful weight maintenance. I would suggest that it's low calorie foods that are the key to weight maintenance. And I don't see any reason that low calorie dairy products aren't part of a weight loss or a weight maintenance diet, Roland.

So, I'm concerned there's this theme that you can only eat plant foods.

DR. GARZA: Johanna?

DR. DWYER: I agree with you, Suzanne. That's why I was talking about -- if you talked about plant rich diets, that might get around that problem because it isn't -- I mean, there isn't any evidence that you can't eat skim milk, is there?

DR. WEINSIER No. I mean, I don't --

DR. DWYER: Or yogurt or cheese --

DR. WEINSIER -- there's any intent to exclude it. It may be just a matter of wording. But so, what you're thinking is saying plant rich implies this is what your building on.

DR. DWYER: Correct.

DR. WEINSIER It's certainly nothing to imply to exclude low-fat dairy products at all.

DR. MURPHY: How about foods from the food guide pyramid that are low in calories or low in fat and sugar?

DR. WEINSIER Yeah. I guess of the view of a number of us is if an option exists, go with the positive statement, not with the emphasis on what you can't have, what you've got to reduce or that we're counting calories. But it's more of what we can do day by day, whether it's if I eat some more fruit, will that help me? If I eat more vegetables, will that help me? If I use low-fat dairy products versus high-fat, are these things going to help me? These are all steps to improve weight rather than just the old message, "count calories."

DR. MURPHY: Just, I would say from any food group, not just from certain food groups.

DR. WEINSIER Right.

DR. GARZA: Shiriki:

DR. KUMANYIKA: I'll mention it here, although it applies to other guidelines. We don't talk enough about practical things like mixed dishes and portion sizes in here. I was just looking through this again. All of the advice about what to eat refers to specific products like the pictures that appear in the pyramid.

So if we could in the next revision think about being more realistic as to the way food comes because the services, when they're counted from the pyramid are counted by extracting fruits and vegetables from all kinds of mixed dishes, which are a lot of the problem for recognizing the fat in sauces and condiments. So, that's one idea.

And the other is that we should hit the portion size overeating or whatever the right term is much harder than we do now to get a total calorie intake. It's still just a little bit, "Watch out for high fat foods because you're likely to get too many calories." But it doesn't say, "Watch out for the 15 ounce steak special," that really should be three or four meals.

DR. WEINSIER I agree with you.

DR. TINKER: Have we talked about the graphic to put in for the children?

DR. WEINSIER To the extent that we agree that a graphic needs to be included preferably if we can weave in with the current figure so that it encompasses enough range of weights and heights to encompass the kids and then adjust the BMI according to the standard. What is a normal, healthy, overweight BMI?

So yes, we do need to incorporate something there, some examples there, but we haven't figured out yet how to combine them.

Kathryn, you were thinking of some?

DR. GRUNDY: One quick point about what Suzanne said about the exercise. I realize, like she said, they'll be an extra -- another guide on exercise, but in this one, there should be appropriate balance of food intake and exercise somehow upfront. And I know you've got it there a little bit, but make it up front and emphasize that it's a dual process of controlling calories and exercise. And they both deserve equal attention. And even though there's going to be another guide on exercise, it ought to be highlighted in this perhaps a little bit more than it is.

DR. GARZA: Before we break for coffee, let's look at the somewhat pessimistic in terms of meeting -- one more meeting after September and set dates. Before we leave, Johanna, I realize that we should have done this while Rachel was still here. But, Rachel will be coming back tomorrow so that we can at least have two time periods for setting possible meeting dates. Then, we can look at the next stuff.

DR. DWYER: What is the one in September?

DR. GARZA: Seventh, eighth and ninth.

DR. DWYER: Are we meeting in Hawaii?

DR. MURPHY: At least California.

DR. GARZA: As long as you're coming all the way to California, you might as well come to the East Coast.

DR. MURPHY: No, not true.

DR. DWYER: Is it possible, Bert?

DR. GARZA: What?

DR. DWYER: Having a meeting on the West Coast for those who are West Coasters.

DR. GARZA: There's only one.

DR. MURPHY: No. There's Lesley.

DR. GARZA: Lesley, where are you on the West Coast?

DR. TINKER: Seattle, Washington is pretty West Coast.

DR. GARZA: Well, that's two out of how many?

DR. MURPHY: I'll vote for Hawaii.

DR. GARZA: Because it's eight hours. Let's -- we'll talk about it. How is that?

DR. MURPHY: Okay.

DR. GARZA: The meeting that we have in September is now scheduled for the 7th, 8th and 9th. If we have a meeting, then trying to meet before November doesn't make a lot of sense. So it'd be either November or December.

DR. DWYER: I'm willing to stay in Hawaii for this.

DR. GARZA: We may go to Thanksgiving in Hawaii. Hawaiian luau? Is that the idea?

DR. MURPHY: Sure, I'll arrange that.

DR. GARZA: I don't see why you don't want to come to Washington.

DR. DWYER: But, you don't like enjoying food, either, right?

DR. GARZA: No, it's within certain limits. Okay.

DR. STAMPFER: When's our due date?

DR. GARZA: The due date is theoretically December 31.

DR. DWYER: I don't think we want to fly December 31.

DR. LICHTENSTEIN: Boston in December.

DR. DWYER: Yeah, Boston's a very good place for a meeting, too. There's a preponderance of people from Boston.

DR. GARZA: We do have over-representation of that area. That's right.

DR. LICHTENSTEIN: This is the northeast corridor right here.

DR. GARZA: For right now, let's stick to Washington for a variety of reasons -- for several reasons, for adequacy. For the purpose of adequacy, balance and moderation, well, maybe not moderation. Is the week of the 16th of November a possibility? Sixteenth, seventeenth and eighteenth?

DR. KUMANYIKA: No.

DR. GARZA: All right. What about the 30th, 1st and 2nd? The 30th of November, first and second of December?

MR. DECKELDAUM: When is Thanksgiving?

DR. GARZA: Thanksgiving is the 25th. It'd be the preceding week. We'd meet on a Tuesday, Wednesday and Thursday following Thanksgiving. So, we'd go to the 30th, 1st and 2nd? Is that a possibility?

And just so we have at least two choices for when Rachel comes, what about the 14th, 15th and 16th of December? Because we would have just met the month before.

MR. STAMPER: Well, that's true. It would be towards the end.

DR. GARZA: Well, what about the 26th, 27th and 28th of October? Then, we're back to the 14th, 15th and 16th of September with a preference for the 30th, 1st and 2nd. That's our first choice. Second choice would be 14th, 15th and 16th with the hope that we wouldn't need the last meeting.

DR. WEINSIER It will make sure we work hard.

DR. GARZA: That's right. Okay. Then, let's break for coffee and be back at four o'clock.

(Whereupon, a short recess was taken.)

DR. GARZA: Okay. We're going to move on then to physical activity. And obviously, because we've begun working on this guideline, only in the last few weeks, I don't think you'll see as much detail, but perhaps Roland is much more efficient that we give him credit for. I don't know. He might have developed the whole thing by now. Well, that's our expectation, Roland, anyway.

DR. WEINSIER I don't feel the pressure anyway.

Okay. As I think everyone knows, but to just make sure we're all on the same footing to start, at the last meeting, there was a great deal of discussion about the importance of physical activity, and that it wasn't coming across in the current edition of the guidelines under the weight control section. Issues were raised that it really addresses -- physical activity addresses a lot more and has a potential to relate to a lot more than just weight -- weight control. So, it was recommended that a separate section be developed.

Let me have the first slide, if you will. In the process of trying to -- go ahead and skip that one for now. Well, leave it up there for a second. I mean, we've already gotten comments made, but there's not much here to be fleshed out. I mean, individual responsibility, interrelation, physical activity, nutrition and prevention. So, we do have a few suggestions. But go on to the next one. At this point, there's not really much to react to.

The committee members that Dr. Garza are listed here and the support team. And also, there were a list of about 11 external advisors that were recommended. The ones listed here, which includes Drs. Synconlos, Paulman, Nelson and Pi-Suyner (phonetic) were those that were able to participate with us in a conference call on June 3. Unfortunately, the conference call had to be scheduled on the ACSM meeting. And a lot of people, particularly the exercise/physiology people were at that meeting. So we still got a lot of the cream of the crop. But unfortunately, not as many as people as we would have liked to have had.

So a lot of the comments I'm including here are going to be based upon the comments made at the conference call, in addition to preliminary readings of some national published guidelines related to physical activity.

The issues that we addressed during the conference call are the following six. And I'll come back to each one of these individually, but fairly briefly.

Number one: Should there be a separate guideline of physical activity? That was the suggestion of the committee for our consideration, but this was posed to the panel of advisors, as well.

Why is physical inactivity a public health concern? What is meant by physical activity versus exercise? What is meant by physical fitness versus functional fitness?

Number four, what, if any, published reference guidelines and position papers should form the basis for the new guideline? In other words, where is our starting point to build a new guideline?

Number five, what are the benefits of specific types and amounts of physical activity and exercise?

And Number 6, what are targeted messages, and who are the targeted populations for this new guideline?

So, go to the next one, which is Issue Number One. Should there be a separate guideline? And when the question was posed to the external advisors, the comment was basically a consensus yes, it does not belong solely under weight control guideline. The justification, the comments made, were that physical activity and nutritional status are linked, but physical activity affects many aspects of health other than obesity and through mechanisms other than energy expenditure and weight control.

Next overhead dealt with the second issue. These are not necessarily prioritized. These are just the six issues.

Why is physical inactivity a public health concern? And the feeling is on the basis of the comments made as well as the first review of published documents that physical inactivity increases risks for cardiovascular disease, hypertension, Type II diabetes, colon cancer, possibly breast cancer. This needs to be fleshed out. More information needs to be gained before we want to make any comment about that, but possibly breast cancer. Osteoporosis and arthritis, obesity and weight regain.

And even though this may seem very clear to us, we accumulating data that already impress -- not that I've done the study, but I'm reviewing the data -- even give us pause with regard to this issue. That we have to be very careful what we can say and what can't say -- what we can't say, because even though intuitively, we want to think that physical activity is critical in controlling body weight, the randomized control trials are not as clean as we'd like them to be.

Traumatic falls, back pain, disability and reduced mental health, low self-confidence, especially in youth are other issues that have been raised. So, there are lots of reasons to believe that physical inactivity is a concern and should be addressed as an important and a distinct guideline.

Issue Number 3: What is meant by physical activity versus exercise? What is meant by physical fitness versus functional fitness?

So, the first issue first. What is meant by physical activity? And basically, what we're being -- what is being suggested is that physical activity should be considered all daily activities which entail physical movement encompassing low intensity things such as gardening, all the way up to vigorous, structured exercised that might be done in the context of a gym.

Encompassed under physical activity would be exercise. So, this is a component of physical activity. It encompasses planned or structure sessions of physical activity specifically intended for such purposes as increasing physical fitness, energy expenditure or simply relaxation, perhaps other things. So this is again, a component of physical activity, rather than being an either/or.

Physical fitness considered definition being changes in health parameters in response to physical activity and exercise training, but encompasses things such as flexibility and balance, cardiorespiratory conditioning, endurance time, muscular strength, functional fitness, as well. And in turn, functional fitness is probably considered under physical fitness or one component of physical fitness. And that is, that this component encompasses capacity to perform daily physical activities.

And I think it's worth having this distinction because this may be a major issue for a large part of the population, particularly, the older adult population. That it's not just a matter of trying to increase physical fitness, which we traditionally think of as the 02 max relative to your weight. But, it may encompass functional fitness, which is a critical component for a number of people, being able to stand from a chair as pointed out. I mean, this is a very important part of daily functional activity.

Next issue, Number 4. Which, if any, published reference guidelines and position papers should form the basis for the new guideline? And I'm open to any suggestions that anyone has to add to this list to help us get a head start.

The ones that we've been able to identify so far, the following listed here. The 1995 CDC American Journal Sports Medicine Physician Paper, the 1996 Surgeon General's Report, the 1996 NIH Consensus Panel Report, the 1997 CDC Report. This deals more with pediatric, i.e., the school and community programs for lifelong physical activity among young people -- 1998 ASCM position stand, 1998 ASCM took another position stand, slightly different theme. This one dealt with older adults. 1999 Conference Report, Americologist Sports Medicine and Resistance Training.

And interestingly, there are since 1965, if I remember the numbers roughly correctly, there are about 33 published guidelines or reports -- guidelines that relate to physical activity. And of those, I went back and quickly tried to review how many dealt with resistance training or strength training in contrast to aerobic training.

And less than about 16 percent either addressed it at all or made a recommendation with regard to resistance or strength training. And I don't know what that's telling us. It may tell us that there's no information in this area. It may tell us that it's not important.

But I think that's something that this working group has to distinguish to decide whether we should bring this in, because my bias is right now that there's just not much information on resistance training. There are not that many studies that have focused on resistance in contrast to aerobic training, but it may have a very distinct, perhaps complimentary on overall health.

Think about it for a second. Strength training may be important in terms of the ability of an older person to stand, to climb stairs, to carry a load, a bag of groceries, a child, you know, whatever, in contrast to aerobic capacity which certainly helps with swimming, walking. So anyway, I'm just bringing this for our consideration because I think it may be important. Unfortunately, I think we're going to be hampered by lack of data.

Nineteen-ninety-nine ASCM report on physical activity throughout the life span, and finally, 1999 PSH Health People 2010, which is a draft report, but has already addressed some issues related to physical activity.

Then, the next, the fifth --

DR. LICHTENSTEIN: Roland? Can I just ask you a question?

DR. WEINSIER Sure.

DR. LICHTENSTEIN: Besides that some of those reports dealt with different age groups, in your opinion, is there any inconsistency, let's say, with the aerobic exercise statements, or are they all pretty consistent?

DR. WEINSIER Among these or among --

DR. LICHTENSTEIN: Yeah. Among the ones you reviewed. I guess the more recent ones that you listed on the previous transparency.

DR. WEINSIER Well, first of all, I haven't gone through them all.

DR. LICHTENSTEIN: There are more?

DR. WEINSIER No. I mean, I haven't even gotten copies of two of these.

DR. LICHTENSTEIN: I see.

DR. WEINSIER And the others, I've barely gotten through. Some I've read and some of them, I'm just, you know, skimming. I mean, this is all since June 3 roughly, and I told Bert that I wouldn't be able to do anything before July 1.

DR. LICHTENSTEIN: The question is premature.

DR. WEINSIER So, my answer is unsatisfactory is the bottom line.

What are the benefit of specific types and amounts of physical activity and exercise? And my thinking is or our thinking is that we need to consider and compare these five components as a minimum. What I've already talked about, aerobic versus resistance, low versus high intensity. And this is, I think, potentially very important, but unfortunately, limited data.

And Steve Blair commented yesterday morning that intensity is not a big issue. And yet, in all the reports and even in his presentation, they talk about of at least moderate intensity. So, it is addressed in a sense. And yet, verbally, we're hearing that it's not that important.

Russell Pate talked about intensity, and indicated that there may be importance to intensity in exercise of physical activity of children. So I think we do need to think about it, but I don't know if we're going to have an answer.

Intermittent versus daily. I put this up because there is some recent data suggests that there may be benefits more of one than the other. This is also the case, short versus continuous bouts, of some data -- of perhaps when you're working out, whether at the gym or in an unstructured program, that having short on and off type of exercises may be adhered to better than continuous exercise.

And then, finally, the structured versus a lifestyle approach. And this is based upon some recent data, particularly, two articles you may have seen in JAMA very recently, suggesting that these two maybe very similar in their potential impact on weight control. That it doesn't have to be the traditional structure, go to the gym three times a week for 30 minutes sort of thing. But that a lifestyle approach can be just as effective for long term weight control. So we need to consider those issues.

And then, Number 6, what are targeted messages, and who are the targeted populations of the guidelines? First of all, the targeted message, the feeling was in the conference call, increase total daily physical activity. Both structured exercise and lifestyle activities are important.

Can we say one is more important than the other? I'm not sure that we can at this point. But we certainly should consider emphasizing both. And I'm not sure there's going to be data to indicate that one overrides the other. I don't think anyone could say that lifestyle is certainly going to be an important component.

Secondly, should we -- question marks here -- increase physical activity for its own sake? In other words, should the message say that we should increase physical activity for its own sake, not necessarily for improving physical fitness or health. I mean, that's clearly an outcome we expect. But, the issue has been raised, it is important to be physically active because it feels good or whatever and not relate everything to "you need to get out and walk, swim, whatever for the sake of improving fitness or health." I don't know. I don't remember how this came out, but this issue has been raised.

A suggestion was made that it's probably going to be congruous with the consensus of most reports that are currently out there if we went with three levels. So, this is very, very tentative and just to get some things on the table. But, very loosely structured that Level 1 of physical activity would be decreased the level of sedentary activity. In other words, if you're not moving, start moving.

Level 2 would be to engage in 30 minutes or more minutes per day most days of the week in some type of moderate, at least moderate intensity physical activities.

Level 3 would be don't have to stop there. You can derive further benefit from additional strength and endurance activities.

So, this gives you some feeling for the thinking of what types of guidelines may come out of this first draft. But, whether there's consensus on that, we're a long ways from saying that.

There were some suggestions turned in, and that goes back from the public. And one dealt with physical activity goes hand in hand with sound nutrition guidelines and should reflect this interrelationship. And we have to heed that, and I think we should and will.

Strengthen the language concerning importance of physical activity. We've addressed that already just by thinking about a separate guideline.

Convey the role of physical activity in preventing obesity and decreasing chronic disease risk. And I think that we will do that.

So, that's as far as we've gotten. I'm open for suggestions.

DR. GARZA: Shiriki?

DR. KUMANYIKA: I missed the conference call so I didn't have a chance to comment on this. The mentioning of subgroups is not really consistent with the way the rest of the guidelines are formulated. I think you could think of mentioning ethnic subgroups in the weight guideline and some other places like food consumption in African Americans is unusually low according to the national data.

Because it's not consistent and it opens up some -- a lot of issues, probably I would recommend against anything except our usual procedure of making sure that it's clear if it applies to children or making sure that it's clear that it applies to older adults or doesn't, and leave the sub-grouping issues for later implementation of people and the guidelines.

DR. WEINSIER Do you think our work group should consider identifying subgroups that are particular risk either from physical -- well, particularly, physical inactivity? I mean, they're certainly older and younger extremes, you know, at greater risk for physical inactivity. The less affluent versus more affluent. Some sub-populations including the Blacks and Mexican-Americans. So, this information is out there.

Are you giving me a different suggestion?

DR. KUMANYIKA: Yeah. The information is there, but we have -- I mean, we really haven't discussed it but we're not writing these guidelines with specific reference to the disproportionate risk in social economic or ethnic groups because you'd have to totally rewrite the weight guideline, for example, to pick up on the excess prevalence in minority groups and so forth. And a lot of the things we've said around the table raised concerns about whether low income people can afford them.

So, I think we should either be consistent and do that across the board, which makes it much more complicated, or we should not single out low activity in Blacks and Hispanics and mention it in this guideline and not mention any other subgroup issues. It could be misinterpreted politically.

DR. GARZA: Johanna?

DR. DWYER: I think that you are absolutely on target. Roland, the reason -- I've gotten into this on catch. And I think our data is flawed because we don't have socioeconomic status. We have raised ethnicity, but no socioeconomic status. And so, you attribute things to race ethnicity that are actually a function of something that's modifiable, which is income. You know, everyone can win the lottery.

And so, I think it's a mistake to that if we do that, then it's not going to get us very far. I don't know if it's as bad with physical activity as it is with a lot of other things, but I bet it's socioeconomic status oriented. And once you take that influence out and urban versus rural, you don't have much left for race ethnicity.

DR. GRUNDY: Johanna, do you think people that win the lottery lose weight? That will be a nice study.

DR. DWYER: Yes, they go in spurts.

DR. GRUNDY: We know they develop diseases.

DR. GARZA: Richard?

DR. DECKELBAUM: I think even though it's not an official guideline yet, you can be congratulated on terrific job there. You sort of got us almost synthesized. I'm sure you can have it ready by tomorrow morning.

But, just a couple of comments. You had one. I think it was Issue Number 4 where you had the different types of exercise?

DR. WEINSIER Number 5, whatever. Different types and amounts.

DR. DECKELBAUM: And you mentioned that there's not a lot of information available on it. And I think the key message is just to get out and do it sort of along the different levels that you suggested and not get bogged down too much in the different types because I think one, there's not complete agreement in that field, and two, there's probably a paucity of data.

The other question I had, which I guess is to the Government agencies is since this is a new guideline, it's been said that these guidelines actually form the basis of what -- for regulations. And since there's a tendency or an actual practice to sort of decrease physical activities in schools, and even build new schools without gyms, is this an opportunity to try to counteract this, which I think is a bad thing that's happening with the kids, to put in recommendations that children during their school hours should have access to a gym and be taught how to get active in physical activities?

DR. GARZA: We thought of suggesting that unless kids can do at least 20 push-ups, they won't get their cafeteria meal.

DR. DECKELBAUM: By law. No, but I'd ask that to -- is this stepping -- Eileen, would this be stepping on toes, or is this something within -- can we do that in this committee, and would the USDA let it go through?

DR. KENNEDY: Depending on what you mean by this is, but let me very clear. When you look back at the statute which authorizes this, I think you're hitting on an important point. It talks about actually the mandate to the committee being to review the guidelines and revise as necessary, which does not preclude having new guidelines, does not preclude potentially having some vanish.

The other two issues are the -- also need to look at ways of promoting the guidelines. And thirdly, the two departments in all of government, in fact, where it specifically talks about USDA and HHS, using these as the basis of policies and programs, et cetera. So, I think we would look very specifically at the implications of the guidelines for what we do.

I will say, and Linda may have more to add on this. The resistance we sometimes get when we're dealing with schools is the thought that when you're dealing with the whole arena of health nutrition, the sense, even on the part of very enthusiastic schools, that all the interventions get focused on a school-based intervention. And what we're hearing more and more is a plague to think about expanding our horizon and thinking about community, home-based interventions very broadly put, and that there's only so much leverage out of a school day.

And that doesn't preclude -- I mean, clearly, we will look at -- across our range of programs the implication of the guidelines. But again, I think as we are thinking about and I know in 2010, we've been involved in some discussions on this, thinking that a range of ways of applying both dietary guidelines, if there were physical fitness guideline in ways that are innovations and taking into account new constraints that have emerged in the population.

So, getting, I think, in many cases, well beyond schools.

DR. GARZA: Johanna?

DR. DWYER: I think that's a great idea, Eileen. This is a wonderful outline, Roland. I don't know how you made sense out of our babbling on that telephone call.

But, it seems to me in terms of the age groups that we should focus on age groups. I'm not sure ethnic, race is a good thing to focus on, but age is. And specifically, in addition to the broader venues then simply the obvious one of school, we need to think for older people the various venues I think there, too.

DR. GARZA: Alice?

DR. LICHTENSTEIN: That's exactly what I was going to bring up. I think that there is a evidence base certainly for older individuals, and you alluded to it, and I just sort of wanted to encourage you to continue along that line and also compliment you on putting it all together. It's certainly been a while in the coming.

DR. GARZA: Scott?

DR. GRUNDY: Just wanted to ask a kind of generic question about justification for including physical activity in nutrition guidelines. One question is whether we're stepping on anybody's toes in the Government. Are there corresponding guidelines out there that -- in which we are crossing over some demarkation there. If so, I think we ought to know about that.

But, the other thing is how well you justify linking physical activity to nutrition. And maybe more could be written there on what is the link between the two and how you justify it.

DR. WEINSIER It's my understanding at the last meeting, we discussed this issue, and someone pointed out that the American Cancer Society has established their guidelines, one of which among the guidelines included physical activity. But, it's kind of ironic that I was asked to chair this subgroup because if you remember last time, we vote on whether there should be a separate physical activity guideline. I was the only one that voted against it.

So, this is the kind of punishment -- the reason I voted against it was because as important as I think it is, I have trouble understanding how it fits as a dietary guideline. I'm still a little troubled with this because I'm trying to picture some overarching story in the guidelines so that just like a reporter interviews us, and we've got in our minds, we want to make one point.

So, regardless of the question, we're going to make our point. Regardless of the consumer's interest when they open this guideline, regardless of which bullet they look at, the message should still come across that here are the key components.

And basically, the key that seems to transcend all of this is basically, you know, a plant rich diet. Whole grains, fruits and vegetables, low-fat dairy products. I mean, it's a pretty common theme, and we've woven it in to almost every guideline. But, what am I going to say in physical activity?

And so, now, I'm wondering, is it really a separate activity guideline that we want? Is this an introductory section where we could pull this out?

DR. GARZA: We asked that question of the expert, and I don't know whether Roland wants to summarize the response that we got, but all of them said that, in fact, they were very pleased. Much of what you heard from Steve Blair and Russ Pate, because they felt that, in fact, it was very difficult to separate diet from physical activity. And they were so intimately related that they didn't see any conflict.

But, in the end, I mean, Roland was absolutely right. You have to feel comfortable with being able to make that linkage.

And we haven't taken the final decision, and we ought to use this time to discuss the presentations that we heard yesterday, not only the summary of a possible guideline that Roland has given us, to make sure that we are either convinced that we ought to proceed with its further development, or to stay "Stop" for the reasons that Roland voted against this to begin with.

DR. GRUNDY: By asking the question, I'm totally convinced we should, but I want to see, you know, how well we justify it because I think there may be other people who say we --

DR. GARZA: I don't think we're speaking against it, but take advantage of the fact that we should discuss that and have a very conscious decision made.

DR. DECKELBAUM: Well, first of all, when we get concerned about what industry, the food producers might say this is good news for them because with the increase exercise, we'll have to increase our food intake to keep up. I mean, you know, only 75 percent will lose weight. So, it's good news for the food producers.

I guess the other thing is that many of us go to nutrition meetings, and we always are talking about the importance of balancing physical activity exercise with nutrition. But, in fact, the physical activity section usually gets a minor part of the meetings. And we're really talking here again about implementation.

And I think the major reason for -- an important reason for keeping it separate is that in terms of its implementation and specific recommendations that are going to come out, it will have an individual and higher impact if it comes in a separate guideline then if it's mixed together with the food one, because that's what's happening all the time, nutrition and physical exercise. And then, physical exercise gets into a third tier.

DR. GARZA: Alice? No? Shiriki? Suzanne and Lesley? No. Shiriki?

DR. KUMANYIKA: I think it would -- I'm definitely in favor of this as a separate guideline, but we do need to articulate the links between physical activity in the context for eating a healthful diet. I mean, the one that -- well, many of them relate more or less to weight control, just to include, but for adequacy, keeping the level of energy requirements high enough to get micronutrients from food so that people don't think they can exist on a 700 calorie a day diet in order to maintain their weight.

But also, some of the broader issues about improving overall health risks so that the dietary factors, which don't work alone, will have more impact. I think we should really list those out as clearly as we can so that it doesn't seem like this will stuck out like a sore thumb in the middle of a dietary guideline.

DR. GARZA: Suzanne?

DR. MURPHY: Took the words right out of my mouth. Older, very sedentary woman cannot possibly meet all the DRIs for nutrients. So, I think physical activity is intricate -- intimately involved with nutrition.

DR. GARZA: Lesley?

DR. TINKER: One of the things that we've been talking about for the last two days is the weight maintenance and obesity in the country, and I'm suggesting strengthening that message within the targeted messages. So, along with the health and the increased calories or all of those components, but to strengthen the whole aspect of increasing physical activity. I don't know if it would be somewhere after Level 2, but beyond that 30 minutes per day for the energy for weight maintenance or weight loss.

And then, another question for people that are sedentary, and let's say, we really get lucky and this motivates them to start doing more physical activity, do we need to put any cautions in there about how to start slowly or you know, avoiding injuries?

DR. WEINSIER And what is your feeling about separate versus --

DR. TINKER: My feeling that separate versus --

DR. WEINSIER Should it be a separate guideline or woven in or introduced as an introductory section or part of Suzanne's section? A catch-all section.

DR. MURPHY: The clever way to avoid calling it anything.

DR. TINKER: I support it as a separate guideline. I think there are a number of nutrition messages that can support that. And so, what I worry about is whether altogether they're cohesive messages, such as the one needing to increase physical -- or potential of increasing physical activity so that you can increase your calorie intake and therefore, get more of your micronutrient. Is that going to conflict in somebody's mind with, "Well, what about the weight maintenance and weight loss?"

So, how to those guide people into probably choosing of the different aspects that link the nutrition, choosing what might be most useful for them. But, I do support it as a separate guideline.

DR. GARZA: Meir?

DR. STAMPFER: I also heartily support as a separate guideline for all the reasons given. And I think what part of the message, I think, should emphasize to some degree walking and brisk walking because this is something that's within the reach of almost everybody, and you don't need special equipment or anything. And people don't need to think about a whole big change in their life, but just getting out there. You get a lot of benefit just from that first initial step from slothfulness.

DR. LICHTENSTEIN: I would just like to point out another advantage of separating the guidelines as one. It was in balance with -- was it --

DR. WEINSIER Balance your --

DR. LICHTENSTEIN: Energy intake just so that there's an opportunity for pointing out that there are other advantages of physical activity independent just of the issue of weight. If it's nothing more with that little old lady of being able to open a jar so that she can eat the vegetables or fruits actually that are in the jar because it's harder for her to go out and get fresh fruits and vegetables. But, those kinds of things, activities of daily life with older individuals can be very critical to their access to foods and actually consuming what we would hope they would be. So, again, another reason for supporting an independent one.

DR. GARZA: Johanna?

DR. DWYER: I think you raised a good question, Scott, and I've been trying to think for a couple weeks about this. About whether exercise -- I'm sorry. Whether physical activity, and I heartily support Dr. Stampfer and Dr. Lichtenstein's emphasis on the basic level of getting from inactivity up to something for myself and for everybody else, too, is very important.

But, the thing I've been playing around with, and maybe you can help me, is whether physical activity and dietary intake are identical twins, back to Dr. Bousshard, fraternal twins or Siamese twins. And I've been thinking that maybe they're Siamese twins because when one changes, then the other one does.

But -- and, I know that sometimes they're fraternal twins because one gets fat and the other is not fat. But, I don't know what the best analogy is. And I think it should be a separate guideline, but I need to think more about it.

In terms of having a separate guideline, one thing in favor of it is it brings together a lot of things that are not now very accessible to those of us who are perhaps more sedentary than some of the people who wrote the guideline. And that is, people -- the President's Council for Physical Fitness, all of these materials that are out there that a lot of people know about, but I, for one, am not very knowledgeable about, or wasn't until I went to the American College of Sports and whatever last -- a couple of weeks ago.

But, if we're going to do this, I don't think we should oversell it. And there are people who know that they have to be more physically active and don't find this the ultimate high. I think one of them was Winston Churchill, but there are a lot of other people, too, who really don't enjoy it very much, even though it is a good thing for their health. And they know they should do it, and they do do it.

So, I don't think we should oversell it and act as though this is the new nirvana. It may be for some people, but I'm not sure it is for everybody.

DR. GARZA: Okay. Then, we'll continue working on the guideline and take the final decision over the summer, I guess over e-mail, and then at our September meeting.

I know that Johanna's leaving in a few minutes, so before, let me make (laughter). I thought it was 2:55. Then, they told me 4:00. Now, it's 5:00. I thought we'd never get rid of her.

But, in all seriousness, there are two guidelines in terms of bullets that we need to think about. One is the previous variety guideline and the other is the fat guideline. And so, I would ask that each of you as you send in your ideas for both, to make every effort to move towards the middle. It's not going to be very helpful if each of us just restates positions that we've stated here.

And I think that if we all make a conscious decision to move towards that middle, then it's going to be much more likely that we're going to find a creative solution that everyone will be feel comfortable with, not because we've compromised, but because, in fact, we have been able to meet all the concerns that various individuals have around the table.

I know the former variety guideline group is going to be meeting today for dinner. I'll be joining them. And so, they're going to continue considering --

DR. LICHTENSTEIN: And anyone else that wants to come.

DR. GARZA: And anybody else that wants to come, an active variety. Why not? But, please think about how, in fact, we might be able to come to a consensus so that we can really end the process in September in a very constructive way.

Johanna?

DR. DWYER: I will have a choice of Southwestern chicken or some other -- there are about two foods that they serve on this airline I have to take. And the basic point is, I would hope that when you meet for dinner with this elaborate piece that you're planning for yourselves, and you think more broadly about variety than simply whether it's associated with chronic disease risk reduction. There is something to be said for pleasure. There's a lot to be said for pleasure. And part of the joy of --

DR. GARZA: We're back on the seven deadly sins, I can tell --

DR. DWYER: Oh, no. This is another sermon. Part of the joy of living is eating even for those who eat 20 percent or 10 percent or two percent. There's room for all of us in enjoyment. And I think that we've lost that in these guidelines. They're a little antiseptic, and we need to think about that -- I don't know if you want to call it variety or nutritional polygamy or whatever. But, whatever you want to call it, there's something to be said for that concept of variety in the broader humanistic sense. And I hope it's not lost on you while you enjoy your food and I have to eat my unvaried airline food.

DR. GARZA: The other point that I'd like all of us to think about especially those of us that are coming back tomorrow, and that is the true constructs that have been offered, the graphic or the table that Shiriki put together. If you don't remember what that looked like, we should probably put it up on the overhead so that you all -- so that everybody can see it and think about it this evening.

The other is grouping the guidelines in some way because we are moving to 10 if we continue down the path that we're going, in a way that is going to be more user-friendly. And Suzanne has given us one framework for that. That is to group them along lines of adequacy, moderation and balance. And you may think of others this evening. And Johanna, while she's enjoying her southwestern chicken may decide to forego dinner and think about other ways. Have a real pleasurable experience and avoid the culinary disaster she's about to encounter.

And on that note, we'll move to alcohol.

DR. MURPHY: I also wanted to mention the dietary alliance book that everyone got has some interesting consumer tips on how to organize the guidelines. And I found it useful to review what those were. And there's a sort of revised version.

Is Kathy Carroll still here? No? I'll ask Kathy, but if you all would like to look at the new version that the ADA is coming out with, I think I can get copies for everyone.

Does anyone know if they're available? Oh, Sue, I didn't see you. Can we all look at this, or is it -- okay. It's called -- you know, it's all about you, but it's called an "Owner's Manual."

MS. MCMURRY: Tool kit. It's part of a tool kit that will include a video for nutrition educators to use with clients.

DR. MURPHY: Okay. So, would people like to look at this as you think about grouping guidelines? I found it helpful.

DR. STAMPFER: Well, the hour is late, and I'll try to be as brief as I can. I know some people may be -- would like to put these guidelines to immediate practical application. But, we'll have to just wait a little bit.

This is the summary of the comments that -- from the public on different aspects of this guideline. So, I'll just go through this with my crib sheet here.

Now, the first one is recommendation message, which is kind of a broad category and includes lots of different aspects. The first being that the guidelines should not promote consumption of alcohol and that we need to be very cautious about the message that we're sending so that the wording, both in the guideline and in the text really matches what we believe the science can support.

Along with that -- and so, we've certainly taken that to heart. And the proposed text actually retains the wording of the guideline that's been -- the same wording that we've had for the last several guidelines. If you drink alcoholic beverages, do so in moderation. So, that's really the thrust of it.

There was comment that moderate doesn't really mean anything, and that we should put the specific definition in the bullet point. But, it gets kind of long and cumbersome, and we do define it as it's been done in the past.

Also, under this recommendation message, the question arose how to deal with the really substantial body of evidence supporting a protective effect of moderate alcohol with coronary heart disease risk. And the proposed wording is moderate drinking may lower risk for coronary heart disease, which is consistent with the way we've dealt with other situations in the guidelines where we have a strong body of evidence which fall short of clinical trial data.

In those settings, we say there's no "may" as a caveat, but just as the evidence is certainly in the same league as many of the other guidelines in terms of supporting a reduction in risk without being strong enough based on clinical trial data to say that this is definitely proven.

Let's see. Portion size. There was some question about defining the portion size. The proposed draft sticks to the portion size that was included in the previous documents. I didn't -- I was unpersuaded that the evidence was strong enough to change the definition there.

Consume with food. There was one comment that the current guidelines say -- refer to consuming alcoholic beverages with meals, and the suggestion was to change that to food. That also -- the proposed draft leaves unchanged. That is, leaving it with meals because food is -- was felt to be just kind of ambiguous and just a few peanuts with your beer and so on, wouldn't convey the message of moderation that we were trying to get across.

And also, physiologically, accompanying alcohol with meals delays the absorption of alcohol, and that requires some substantial amount of food, not just a little canape or whatever.

Now, cautions. There were a number of suggestions for more specific cautions about adverse effects of alcohol. And these included breast cancer, alcohol in young people, alcohol in the elderly, and the risk of abuse. And these have all been addressed in the proposed text. Actually, most of them were also addressed previously, but we have added tentatively a note on the breast cancer risk because this is really the only substantial cancer risk for which there's reasonable evidence for harm at a level of moderation that we're talking about, for women, one drink a day. Other health risks pertain to excess alcohol.

We've also strengthened the message regarding alcohol in young people as well as the elderly. And we've specifically commented on the dangers of risk of abuse with earlier initiation of drinking. And so, in the new proposed text, that's explicitly commented on.

Also, I should add for the elderly, the proposal is to change the comment on the coronary disease finding to drive home the message that this apparent benefit is obviously only for people who are at risk for coronary disease. And we had discussed previously about targeting this to men over 45 and women over age 55, and it was interesting and heartening, I should say, in the letter from Enoch Gordis that came recently and sort of completely independently, had made the same suggestion that the subgroup had already put into the draft. So, there seemed to be some convergence there, and that was nice.

There was some comments about either deleting or retaining the phrase, "Alcoholic beverages have been used to enhance the enjoyment of meals throughout human history."

We discussed this at previous meetings. And I believe the consensus of the group was to delete this, not on the grounds that's it not true. It's obviously true, but it's also true that salt has been used to enhance meals, et cetera, et cetera. And we don't say that about any other aspect of the diet, and so why should we single out alcohol for that? So, in the proposed guideline, this has been deleted.

Let's see. Benefits. I think I've already discussed the benefits. There was some question about whether we should discuss the other potential health benefits of moderate alcohol consumption. There's actually substantial data for other health benefits besides coronary disease, but in the draft that's before you, we've chosen not to mention any of the other health benefits on the grounds that the science is not sufficiently strong to support that. And that was also a recommendation from Dr. Gordis.

Also, among benefits, there was a suggestion that we highlight alternative to alcohol consumption for reduction in CHD risk. In the draft that's prepared for you, we have not done that on the grounds that this is not a CHD reduction guideline. This is a guideline focused on alcohol. And we only have one sentence relating to coronary disease, and it didn't seem appropriate to put that in. Alternatives for reduction of coronary risk abound in the rest of the guidelines.

Responsible choice. Well, this is really just to include information about health effects of alcohol, distinguishing moderate consumption from abuse. And we're tried to take this to heart also by highlighting more strongly the adverse effect of alcohol. And in the draft that's before you, we start off I think with a stronger statement than the previous guidelines. The previous guidelines started off with the statement, "Alcohol provides calories, but not much in the way of nutrients," which struck me as a kind of a bland way to get into the subject.

So, the draft that's proposed starts off, "Alcoholic beverages are harmful when consumed in excess" to get the number one issue right out front that we want to avoid any suggestion that could lead to promotion of excess alcohol consumption.

Recommended guideline wording. I think I've already discussed that. The National Institute of Alcohol Abuse and Alcoholism in Dr. Gordis' letter suggested as the bullet point, "If you drink alcohol, women and all persons 65 and over should consume no more than one drink per day. And men, under 65, no more than two drinks per day." That was their recommended wording. It seemed a little wordy to me, but we can talk about whether we want to amend that.

Other beverages. There was a suggestion that we should talk about the health effects of other beverages, but this is an alcohol guideline. The other beverages can go into the other categories, it was felt.

So, those are the -- that's the summary basically of the comments from the public.

Let me just highlight the major proposed changes. And there really aren't any major changes. I think really all the changes are minor. Besides the ones that I've talked about, we've tried to specify a little more clearly, take comments on alcohol during pregnancy instead of just saying, "Women who are trying to conceive," recognizing the fact there are many unplanned pregnancies, so we've changed that to, "Women who may become pregnant because of the dangers of alcohol in the early couple of weeks of pregnancy."

We've also added a little more clarity I think to the potential for interaction with medications. The 1995 bulletin basically said that anyone taking medications shouldn't drink. And this is obviously too sweeping a statement that's really not supported by scientific evidence.

So, the proposal now is to recognize that interactions with medications are common, but not universal. Not every single medication has an adverse interaction with alcohol, and that the recommendation would be to -- especially for the elderly, to seek the advice from their healthcare provider regarding alcohol interactions.

So, in summary, the proposed new text represents only I think moderate tinkering with the previous guideline, and doesn't represent any new major shift in direction.

DR. GARZA: Any questions? Roland?

DR. WEINSIER Yeah. With what little I know about the area, I think you've done an outstanding job. I like the wording.

I had probably a very minor question. You, in fact, asked the question, at the interim advice for today, you gave an option to select one versus the other. And although I like the second option, which starts with, "If you choose to drink alcoholic beverages, limit intake to one drink for women, two for men," and you -- I wonder if it ends on a very different note than it starts, because it starts as you said, just hits you right up front. "If consumed in excess, watch out."

And that's sort of the theme throughout. And then, you go back to moderation and you temper it, which I think it's handled very nicely. But then, by the time I'm closing, I'm left with a feeling that it sounds good. If I'm a man, I can take two drinks a day, and just take it with meals and don't take somebody skiing.

I wonder if it shouldn't be -- even that closing sentence shouldn't be introduced as you did in the beginning, with recognizing alcohol is harmful when taken in excess. If you choose to drink, limit intake to one. In other words, to keep the theme, you know, going. Don't lose it.

And the only other comment related to a second paragraph, I got confused, but it's probably wording, and we don't need to deal with the details here. But, I'm trying to figure out if you're saying that older individuals who are at low risk for coronary artery disease that it doesn't provide any benefit to them.

Are you saying that older adults are at lower risk for coronary artery disease, or that older adults who happen to be at low risk? I couldn't figure out what the implication was. "Moderate consumption provides little or no benefit for younger people or for older individuals who are already at low risk of coronary disease." I think you're trying to say, "If you happen to be old, and happen to be at low risk, it's okay." You're not trying to say that young and old people are at low risk.

DR. STAMPFER: Right. That's not worded well. Thanks for pointing that out. We'll have to clarify that. The intent was to say (A), that there's no net health benefit for young people who are not at any substantial risk for coronary disease. And even for older people, if their risk profile is very favorable, even for older people, there'd be little or no net health benefit. But you're right. The wording doesn't say that as clearly as it should. We'll fix it.

DR. GARZA: Alice?

DR. LICHTENSTEIN: I'm wondering if there's any way to get in the concept -- I think you've done a great job of sort of putting in all the caveats that have been raised on. I'm wondering if it would be appropriate and there's any way of getting in the concept that although, you know, basically, two drinks for men, one drink for a woman, but that different people do react differently and have different tolerances. And for some males, one drink -- two drinks can actually have significant effects even when taken with meals. Or, just that there may be some variation there. And the same way there may be some larger women that two drinks are just fine.

DR. STAMPFER: Good point.

DR. LICHTENSTEIN: I don't know how easy it would be. It's just something to consider.

DR. GARZA: Richard?

DR. DECKELBAUM: Just two points. So, if we consider that over 60 percent of pregnancies are unplanned, so in terms of women who may become pregnant, so that essentially excludes women from drinking, you know, post-puberty till menopause, and so, you know, if you consider that --

DR. STAMPFER: I don't think it does that. I mean, I'm not sure about that figure, but even if that figure is true, it's not the case that 60 percent of women have unplanned pregnancies.

DR. DECKELBAUM: Well, that's the figures --

DR. GARZA: No, it's unintended.

DR. STAMPFER: Unintended, yeah.

DR. DECKELBAUM: Unintended.

DR. GARZA: They're planning one, but maybe in the future. But, 60 percent of pregnancies -- 50 to 60 percent presently are unintended.

DR. STAMPFER: Right. But, the denominator is the --

DR. GARZA: That doesn't mean not wanted and not planned. And people in the health field make those distinctions.

DR. DECKELBAUM: No. I just wonder how you can better handle that either with evidence or some kind of advice. It's a tricky subject.

The other point is in Sweden, you know, two drinks is enough to get you arrested and off the road and lose your license for a couple of years. So, you know, when you give advice for today, I like, actually, the second choice better because it's specific. But, I think it should say, "Avoid any drinking when it puts you and others at risk," or when -- "such as when operating a vehicle," because two drinks would put you over the legal limit in many countries for driving a car.

So, you know, when you say avoid drinking, you mean any drinking or going over -- I guess you meant, we should never go over the two drinks a day, but I think it's got to be very specific, but there shouldn't be any drinking when you're driving or operating machinery, et cetera.

DR. STAMPFER: I'm not sure how, you know, how to operationalize that because two quick drinks on an empty stomach is quite different from two drinks taken in the course of a dinner, you know, over several hours. It doesn't always raise your blood alcohol to the point -- to the legal limit of Sweden. It depends how it's taken and what the circumstances are.

DR. GARZA: And the bullets, Richard, right before advice for today, both of those points are made. One that individuals who drive and operate machinery should not drink. And then, that, in fact, there is zero tolerance for drinking in pregnancy. So, if you think you might become pregnant, yeah. I mean, you shouldn't.

Shiriki?

DR. KUMANYIKA: I think this is really a welcome revision given the concerns we had early on. There's one obvious thing that isn't stated here, and I wonder if we want to go the next obvious step to mention that people don't actually need alcohol, because the rest of the guidelines are for things that one way or another, you have to have them in your diet to be healthy. But, this one is really optional. And that's implied. I mean, sort of everybody knows that.

But, it's something to consider to put in here that, you know, nobody needs to drink, but some people do. For young people who are coming up who think that what we're telling them is figure out how to fit alcohol into your life, we could make that point.

DR. WEINSIER Can I respond?

DR. GARZA: Roland?

DR. WEINSIER My reading of that first sentence said that to me, but said it even stronger. In other words, it if were presented differently that alcohol is not necessary -- is not an essential part of a healthy diet, that's quite a different message from saying alcoholic beverages are harmful when consumed in excess.

DR. KUMANYIKA: Not instead of this, but under the advice for the day, it just really doesn't --

DR. WEINSIER No, I see what you're saying.

DR. KUMANYIKA: It doesn't ever say that these other dietary guidelines are telling you how to work with things that you need, and this one talks about something that people include in their diet. But, it's not needed. And I was trying to think about ways or a way to put that.

DR. GARZA: Okay. Any other comments?

DR. GRUNDY: Just one small comment. It seems like in right at the first, you talk about the harmful effects, and then you interpose in the beginning of the next paragraph some potential benefits, and then you get back to the harmful effects. I don't know whether that flow is proper or not. You might think about whether you could have it all -- have it separated quite clearly.

DR. WEINSIER Just break that paragraph.

DR. GRUNDY: Well, maybe it's kind of mixed -- first, you talk about the harmful effects, and then, in the same paragraph, you talk about the potential benefits and potential harm.

DR. GARZA: I think what's being suggested is that you group all of the harmful effects in the first paragraph.

DR. GRUNDY: Right.

DR. GARZA: And then, in the second paragraph, limit it to the potential benefits of moderate drinking.

DR. GRUNDY: Right.

DR. GARZA: But, rather than going from potential harm to potential benefit to potential harm.

DR. GRUNDY: That's right.

DR. GARZA: That it may be less confusing to the reader if we reorganize it.

DR. STAMPFER: Okay. I actually did it deliberately, although, I mean, I'm certainly open to change. But, I -- the reason that I did it this way was to avoid highlighting the potential benefit too much and to provide a way of talking about the age relationship, because the benefit for coronary disease provides a nice way, I think, to get into the fact that the benefit is really limited to older people. And then, that leads to the harmfulness among younger. But, I'm certainly open to any suggestions.

DR. GRUNDY: Well, I see, I understand what you're trying -- I understand why you did it that way. I'm just -- still think it's a little bit confusing the way it flows back and forth.

DR. STAMPFER: Sure. Well, I'm happy to play around with it.

DR. GARZA: Well, if you look at the way -- the way it doesn't work, then just keep it the way it is.

DR. STAMPFER: We'll try some alternative presentations to see how it looks.

DR. GARZA: Yes, ma'am?

MS. MCMURRY: I wanted to bring to your attention, there was a suggestion to add to the definition of moderation, only one drink per day for people over 65. Is that something that the committee would want to include or not?

DR. STAMPFER: Oh, yeah. Thanks for raising that. I forgot to raise that point. That was a suggestion in Dr. Gordis' letter.

My own read of the literature was that it didn't seem strong enough to support that shift basically cutting the amount in half at age 65 for men, but if others feel more strongly about it --

DR. GARZA: Anybody have any strong feelings about the data for older people because I think the major issue there was one of potential loss of motor control and the falls and accidents was the concern he was getting at.

DR. STAMPFER: Well, partly. And the other part was loss of lean body mass.

DR. GARZA: That the loss of lean body mass could lead to a greater alcohol level, and that that would impair function.

DR. STAMPFER: Yeah. I mean, it's kind of vague anyway because we don't -- we don't relate this to body size particularly. There are male/female differences in metabolism apart from average body size.

DR. GRUNDY: You know, those points you raised are very good. Maybe that ought to be included in the text that falls are a major problem in elderly, and this would be another complication from drinking too much.

DR. LICHTENSTEIN: Because there's probably no evidence for 65 itself being the cut point for bringing up the point that with aging, there is a gradual decrease in lean muscle mass and increase in fat, and therefore, your tolerance may change.

DR. GARZA: May change. And therefore, you may want to decrease your alcohol intake if you choose to drink as you age. That might be an effective way of dealing with it. Of course, for some people that might mean whoever is older than you.

DR. WEINSIER So, basically, the window of opportunity is 10 years for women.

DR. GARZA: Age 55 or 60.

DR. WEINSIER In other words, we're saying, "Put it off, put it off, enjoy it fast."

DR. GARZA: And on that rather depressing note, we will reconvene tomorrow at nine.

The main job that we have to do tomorrow or the following, think about how we might organize the guidelines. If there are issues as you look at the draft of the green document and the guidelines themselves, that you want -- that you feel particularly concerned are not being sufficiently well-documented, then raise those tomorrow so that the various individuals are going to be putting those documents together and have the benefit of your advice.

DR. DECKELBAUM: Tomorrow's schedule I think gives 10 minutes. Is it five or ten?

DR. GARZA: We had to put it down in some structure. We will try and deal with them efficiently, but as we go sequentially through the morning, we will contract and expand. I don't think we're going to need a whole hour. I think we will need an hour for format. For some of the guidelines, we may just here the comments and move on.

(Whereupon, at 5:09 p.m., the hearing recessed, to reconvene the following day, Friday, June 18, 1999 at 9:00 a.m.)


CERTIFICATE OF REPORTER, TRANSCRIBER AND PROOFREADER

Name of Hearing or Event: Dietary Guidelines Advisory Committee

Docket No.: N/A

Place of Hearing: Washington, DC

Date of Hearing: June 17, 1999

We, the undersigned, do hereby certify that the foregoing pages, numbers 318 through 580 , inclusive, constitute the true, accurate and complete transcript prepared from the tapes and notes prepared and reported by Sharon Bellamy , who was in attendance at the above identified hearing, in accordance with the applicable provisions of the current USDA contract, and have verified the accuracy of the transcript (1) by preparing the typewritten transcript from the reporting or recording accomplished at the hearing and (2) by comparing the final proofed typewritten transcript against the recording tapes and/or notes accomplished at the hearing.


Date: 6-21-99

Name and Signature of Transcriber Heritage Reporting Corporation: Nancy McHugh

Date: 6-24-99

Name and Signature of Proofreader Heritage Reporting Corporation: Lorenzo Jones

Date: 6-17-99

Name and Signature of Reporter Heritage Reporting Corporation: Sharon Bellamy


Last updated July 13, 1999