|
||||
 |
||||
Dockets
Management |
||||
|
2001Q-0313 Appendices Appendix
1A - Oatrim (BetaTrim) Enzyme Process Flow-Chart. Appendix 2 - Environ Report: Estimated Intake of Fiber by Consumers of Products Proposed with Oatrim (BetaTrim). Appendix 3 - Self GRAS Affirmation of Oatrim (BetaTrim) by Quaker Oats Co. Appendix 4 - Consensus Statement by ConAgra Expert Panel on Self GRAS Determination of Oatrim Products. Appendix 5 - Opinion Letter by Dr. Joseph F. Borzelleca (Toxicologist) Appendix 6 - Human Studies: Oatrim [including Oatrim (BetaTrimTM)], Oat Gums/Extracts and Serum Cholesterol. Appendix 7 - Animal Studies: Oatrim [including Oatrim (BetaTrimTM)], Oat Extracts, Oat Gums and Enriched Oat Brans. Appendix 8 - Comment C-141 2: Letter submitted by D. Gallaher During the Oat and CHD Health Claim Proposed Rule Comment Period. Appendix 9 - Supporting letter from Dr. Daniel Gallaher. Appendix 10 - Beta-Glucan AOAC Analysis Method, 99 1.43 (Yr. 2000) Published Material Appendix 11 - Exclusion of Nu-TrimX and Z-Trim Published
Material References AHA (American Heart Association), 1999. Economic cost of cardiovascular diseases. www.americanheart.org/statistics/10econom.html Published Material AOAC Official Method 991.43 Total, soluble, and insoluble dietary fiber in foods. AOAC Official Methods of Analysis, 2000. Published Material Arjmandi BH, Sohn E, Juma S, Murthy SR, Daggy BP, 1997. Native and partially hydrolyzed psyllium have comparable effects on cholesterol metabolism in rats. J Nutr 127: 463-469. Published Material Armstrong B, Van Merwyk AJ, Coates H, 1987. Blood pressure in seventh day adventist vegetarians. Am J Epidemiol 105: 444-449. Published Material Ascherio A, Hennekens C, Willett WC, Sacks F, Rosner B, Manson J, Witteman J, Stampfer MJ, 1996. Prospective study of nutritional factors, blood pressure, and hypertension among U.S. women. Hypertension 27: 1065-1072. Published Material Beer MU, Arrigoni E, Amado R, 1995. Effects of oat gum on blood cholesterol levels in healthy young men. Eur J Clin Nutr 49: 517-522. Published Material Behall KM, Scholfield DJ, van dei Sluijs, AMC, Hallfrisch J, 1999. Breath hydrogen and methane expiration in men and women after oat extraction consumption. J Nutr 128: 79-84. Published Material Behall KM, Scholfield DJ, Hallfrisch, J, 1997. Effect of beta-glucan level in oat fiber extracts on blood lipids in men and women. J Am Coll Nutr 16: 46-51. Published Material Braaten JT, Wood PJ, Scott FW, Wolynetz MS, Lowe MK, Bradley-White P, Collins MW, 1994a. Oat beta-glucan reduces blood cholesterol concentration in hypercholesterolemic subjects. Eur J Clin Nutr 48: 465-474. Published Material Braaten JT, Scott FW, Wood PJ, Riedel KD, Wolynetz MS, Brule D, Collins MW, 1994b. High beta-glucan oat bran and oat gum reduce postprandial blood glucose and insulin in subjects with and without type 2 diabetes. Diabetic Medicine 11: 312-318. Published Material Braaten JT, Wood PJ, Scott FW, Riedel ,RD, Poste LM, Collins MW, 1991. Oat gum lowers glucose and insulin after an oral glucose load. Am J Clin Nutr 53: 1425-1430. Published Material Burt VL, Whelton P, Roccella EJ, Brown C, Cutler JA, Higgins M, Horan MJ, Labarthe D, 1995. Prevalence of hypertension in the U.S. adult population. Results from the Third National Health and Nutrition Examination Survey. Hypertension 25: 305-313. Published Material Carr TP, Gallaher DD, Yang CH, Hassel CA, 1996. Increased intestinal contents viscosity and cholesterol absorption efficiency in hamsters fed hydroxypropyl methylcellulose. J Nutr 126: 1463-1469. Published Material Chen WL, Anderson JW, Gould MR, 1981. Effects of oat bran, oat gum and pectin on lipid metabolism of cholesterol-fed rats. Nutr Rep Int 24: 1093-1098. Published Material Elliott P, Fehily AM, Sweetnam PM, Yarnell JWG, 1987. Diet, alcohol, body mass, and social factors in relation to blood pressure: the Caerphilly heart study. J Epi Comm Health 41: 37-43. Published Material Fernandez ML, Ruiz LR, Conde AK, Sun DM, Erickson SK, McNamara DJ, 1995. Psyllium reduces plasma LDL in guinea pigs by altering hepatic cholesterol homeostasis. J Lipid Res 36: 1128-1138. Published Material Freiburger LM, Gallaher DD, 2001. Mechanism of cholesterol lowering in rats fed fermentable and non-fermentable dietary fibers. FASEB J 15(4): A290 [Abstract]. Published Material Freiburger LM, Gallaher DD, 2000. Association between intestinal contents viscosity and cholesterol lowering in rats fed fermentable and non-fermentable dietary fibers. FASEB J 14(4): A291 [Abstract]. Published Material Galibois I, Desrosiers T, Guevin N, Lavigne C, Jacques H, 1994. Effects of dietary fiber mixtures on glucose metabolism and on mineral absorption in the rat. Ann Nutr Metab 38: 203-211. Published Material Gallaher DD, unpublished. Intestinal contents supernatant viscosity of rats meal-fed Oatrim (BetaTrim)-20 from two processing methods: Enzymatic and acid/base methods. (not included) Gallaher DD, 1999. Dietary Fiber in Sports Medicine. In: Energy-Yielding macronutrients and energy metabolism in sports medicine, Driskell JA, Wolinsky I, Eds., CRC Press, Florida 1999. Published Material Gallaher DD, Wood KJ, Gallaher CM, Marquart LF, Engstron AM, 1999. Intestinal contents supernatant viscosity of rats fed oat-based muffins and cereal products. Cereal Chem 76:21-24. Published Material Gallaher DD, Hassel CA, Lee K-J, 1993a. Viscosity and fermentability as attributes of dietary fiber responsible for the hypocholesterolemic effect in hamsters. J Nutr 123: 244-252. Published Material Gallaher DD, Hassel CA, Lee K-J, 1993b. Relationships between viscosity of hydroxypropyl methylcellulose and plasma cholesterol in hamsters. J Nutr 123: 1732-1738. Published Material Gordon DT, Stoops D, Ratcliff V, 1995. Dietary fiber and mineral nutrition. In: Dietary fiber in health and disease, Kritchevsky D, Bonfield C, Eds., Eagan Press, St. Paul 1995, 267. Published Material Granfeldt Y, Elliasson A, Bjorck I, 2000. An examination of the possibility of lowering the glycemic index of oat and barley flakes by minimal processing. J Nutr 130: 2207-2214. Published Material Granfeldt Y, Hagander B, Bjorck I, 1995. Metabolic responses to starch in oat and wheat products. On the importance of food structure, incomplete gelatinization or presence of viscous dietary fiber. Eur J Clin Nutr 49: 189-199. Published Material Hallfrisch J, Behall KM, 2000. Mechanisms of the effects of grains on insulin and glucose responses. J Am Coll Nutr 19: 320S-325S. Published Material Hallfrisch J, Scholfield DJ, Behall KM, 1995. Diets containing soluble oat extracts improve glucose and insulin responses of moderately hypercholesterolemic men and women. Am J Clin Nutr 61: 379-384. Published Material He J, Klag MJ, Whelton PK, Mo J, Chen J, Quian M, Mo P, He G, 1995. Oats and buckwheat intakes and cardiovascular disease risk factors in an ethnic minority of China. Am J Clin Nutr 61: 366-72. Published Material Heaton KW, Marcus SN, Emmett PM, Bolton CH, 1988. Particle size of wheat, maize, and oat test meals: effects on plasma glucose and insulin responses and on the rate of starch digestion in vitro. Am J Clin Nutr 47: 675-682. Published Material Inglett GE, Warner K, Newman RK, 1994. Sensory and nutritional evaluations of Oatrim. Cereal Foods World 39: 755-759. Published Material Inglett GE, Newman RK, 1994. Oat beta-glucan-amylodextrins: Preliminary preparations and biological properties. Plant Foods Hum Nutr 45: 53-61. Published Material Joffres MR, Reed DM, Yano K, 1987. Relationship of magnesium intake and other dietary factors to blood pressure. Am J Clin Nutr 45: 469-475. Published Material Katakam P, Ujhelyi MR, Hoenig ME, et al, 1998. Endothelial dysfunction precedes hypertension in diet induced insulin resistance. Am J Physiol 275: R788-R792. Published Material Keagy PM, Shane B, Oace SM, 1988. Folate bioavailability in humans: Effects of wheat bran and beans. Am J Clin Nutr 47: 80-88. Published Material Keltz FR, Kies C, Fox HM, 1978. Urinary ascorbic acid excretion in the human as affected by dietary fiber and zinc. Am J Clin Nutr 31: 1167-1171. Published Material Lichtenstein MJ, Burr ML, Fehily AM, Yarnell JWG, 1986. Heart rate, employment status, and prevalent ischemic heart disease confound relation between cereal fiber intake and blood pressure. J Epi Comm Health 40: 330-333. Published Material Liljeberg H, Granfeldt, Y, Bjorck I, 1992. Metabolic responses to starch in bread containing intact kernels versus milled flour. Eur J Clin Nutr 46: 561-575. Published Material Malkki Y, Pelkonen K, Myllymaki O, Torronen R, Hanninen O, Syrjanen K, 1995. Effects of oat bran concentrate on rat serum lipids and liver fat infiltration. Eur J Clin Nutr 49 Suppl: S321 -S324. Published Material Miller LT, Schultz TD, Leklem JE, 1980. Influence of citrus pectin on the bioavailability of vitamin B6 in men. FASEB J 39: 797 [Abstract]. Published Material Must A, Spadano J, Coakley EH, Field AE, Colditz G, Dietz WH, 1999. The disease burden associated with overweight and obesity. J Am Med Assoc 282: 1523-1529. Published Material Newman RK, Inglett GE, Newman CW, Hofer PJ, Wang DL, 1993. Beta-Glucan concentrates from oats and barley lower cholesterol in chicks. FASEB J 7(4): A739 [Abstract]. Published Material Newman RK, Klopfenstein CF, Newman CW, Guritno N, Hofer PJ, 1992. Comparison of the cholesterol-lowering properties of whole barley, oat bran, and wheat red dog in chicks and rats. Cereal Chem 69: 240-244. Published Material Ney DM, Lasekan JB, Shinnick FL, 1988. Soluble oat fiber tends to normalize lipoprotein composition in cholesterol-fed rats. J Nutr 118: 1455-1462. Published Material NRC (National Research Council) 1989. Recommendations on diet, chronic diseases, and health. In: Diet and Health, Implications for reducing chronic disease risk. Washington, DC, National Academy Press. Pg: 665-710. Published Material Oda T, Aoe S, Imanishi S, Kariazawa Y, Sanada H, Ayano Y, 1994. Effects of dietary oat, barley, and guar gums on serum and liver lipid concentrations in diet-induced hypertriglyceridemic rats. J Nutr Sci Vitaminol 40: 213-217. Published Material Oda T, Aoe S, Sanada H, Ayano Y, 1993. Effects of soluble and insoluble fiber preparations isolated from oat, barley, and wheat on liver cholesterol accumulation in cholesterol-fed rats. J Nutr Sci Vitaminol 39: 73-79. Published Material Osterberg NA, Gallaher DD, Hassel, CA, 1993. Cholesterol-lowering effects of various fibers and the relationship to intestinal viscosity in rats FASEB J 7: A4271 [Abstract]. Published Material Pick ME, Hawrysh ZJ, Gee MI, Toth E, Garg ML, Hardin RT, 1996. Oat bran concentrate bread products improve long-term control of diabetes: A pilot study. J Am Diet Assoc 96: 1254-1261. Published Material Pins JJ, Keenan JM, 1999. Soluble fiber and hypertension. Prev Cardiol 2: 151-158. Published Material Ranhotra GS, Gehoth JA, Astroth K, Rao CS, 1990. Relative lipidemic responses in rats fed oat bran or oat bran concentrate. Cereal Chem 67: 509-511. Published Material Rattan, J, Levin N, Graff E, Weizer N, and Gilat T, 1981. A high fiber diet does not cause mineral and nutrient deficiencies, J Clin Gastroenterol, 3: 389-393. Published Material Reynolds HR. The effect of whole grain oat cereal on serum lipids. Unpublished, 1996. (See comments C-1412/Appendix 8). (not included) Roe DA, Kalkwarf H, Stevens J, 1988. Effect of fiber supplements on the apparent absorption of pharmacological doses of riboflavin. J Am Diet Assoc 88: 211-215. Published Material Samuel P, Keast DR, Bartholmey SJ, Song WO, 2000. Comparison of body mass index (BMI) and serum cholesterol concentration by quartiles of dietary fiber consumption in adults: the Third National Health and Nutrition Survey. Obesity Research 8: PD 37 [Abstract]. Published Material Sempos CT, Cleeman JI, Carroll MD, Johnson CL, Bachorik PS, Gordon DJ, Burt VL, Briefel RR, Brown CD, Lippel K, Rifkind BM, 1993. Prevalence of high-blood cholesterol among U.S. adults: An update based on guidelines from the Second Report of the National Cholesterol Education Program Adult Treatment Panel. J Am Med Assoc 269: 3009-3014. Published Material Shinnick FL, Marlett, JA, 1993. "Physiological responses to dietary oats in animal models," In Oat Bran, PJ Wood (ed.), American Association of Cereal Chemists Inc, St. Paul, MN, p. 113-138. Published Material Shinnick FL, Longacre MJ, Ink SL, Marlett JA, 1988. Oat fiber: Composition versus physiological function in rats. J Nutr 118: 144-151. Published Material Spencer H, Norris C, Derler J, Osis D, 1991. Effect of oat bran muffins on calcium absorption and calcium, phosphorus, magnesium and zinc balance in men. J Nutr 121: 1976-1983. Published Material Sutherland J, Castle C, Freidman R, 1994. Hypertension: current management strategies.J Am Board Fam Pract 7: 202-217. Published Material Tappy L, Gugpz E, Wursch P, 1996. Effects of breakfast cereals containing various amounts of beta-glucan fibers on plasma glucose and insulin responses in NIDDM subjects. Diabetes Care 19: 831-840. Published Material Torronen R, Kansanen L, Uusitupa M, Hanninen O, Myllymaki O, Harkonen H. Malkki Y, 1992. Effects of an oat bran concentrate on serum lipids in free living men with mild to moderate hypercholesterolemia. Eur J Clin Nutr 46: 621-627. Published Material Trautwein EA, Kunath-Rau A, Erbersdobler HF, 1999. Increased fecal bile acid excretion and changes in the circulating bile acid pool are involved in the hypocholesterolemic and gallstone-preventive actions of psyllium in hamsters. J Nutr 129: 896-902. Published Material Turley SD, Dietschy JM, 1995. Mechanisms of LDL-cholesterol lowering action of psyllium hydrophilic mucilloid in the hamster. Biochim Biophys Acta 1255: 177-184. Published Material USDA-ARS (US Department of Agriculture, Agricultural Research Service), Washington, DC. Fat replacer reduces fat damage. Food & Nutr Res Briefs January 1996. Published Material Wahal PK, Singh R, Kishore B, Prakash V, Maheshwari BB, Gujral VK, Jain BB, 1986. Effect of high fibre intake on serum vitamin A levels. J Assoc Physicians India 34: 269. Published Material Welch RW, Peterson DM, Schramka B, 1988. Hypocholesterolemic and gastrointestinal effects of oat bran fractions in chicks. Nutr Rpts Intl 38: 551-561. Published Material Witteman JCM, Willett WC, Stampfer MJ, Sacks FM, Speizer FE, Rosner B, Hennekens CH, 1989. A prospective study of nutritional factors and hypertension among U.S. women. Circulation 80: 1320-1327. Published Material Wood PJ, Beer MU, Butler G, 2000. Evaluation of role of concentration and molecular weight of oat beta-glucan in determining effect of viscosity on plasma glucose and insulin following an oral glucose load. Brit J Nutr 84: 19-23. Published Material Wood PJ, Braaten JT, Scot FW, Reidel KD; Wolynetz MS, Collins MW, 1994. Effect of dose and modification of viscous properties of oat gum on plasma glucose and insulin following an oral glucose load. Brit J Nutr 72: 731-743. Published Material Wood PJ, 1993. "Physiochemical characteristics and physiological properties of oat (1-3), (1-4), B-glucan," In Oat Bran, PJ Wood (ed.), American Association of Cereal Chemists Inc, St. Paul, MN, p. 85-112. Published Material Wood PJ, Braaten JT, Scott FW, Riedel D, Poste LM, 1990. Comparisons of viscous properties of oat and guar gum and the effects of these and oat bran on glycemic index. J Agric Food Chem 38: 753-757. Published Material Wursch PK, Pi-Sunyer FX, 1997. The role of viscous soluble fiber in the metabolic control of diabetes:a review with special emphasis on cereals rich in beta-glucan. Diabetes Care 20: 1774-1780. Published Material Yokoyama WH, Knuckles BE, Stafford A, Inglett G, 1998. Raw and processed oat ingredients lower plasma cholesterol in the hamster. J Food Sci 63: 713-715. Published Material Zarling EJ, Edison T, Berger S, Leya J, DeMeo M, 1994. Effect of dietary oat and soy fiber on bowel function and clinical tolerance in a tube feeding dependent population. J Am Coll Nutr 13: 565-568. Published Material Page last updated
October 14, 2005
RSC |
