Impact of Trans Fatty Acids From Natural and Industrial Origin in the Induction of Insulin Resistance Development - Full Text View

Sponsored by:	French National Institute for Agricultural Research
Information provided by:	French National Institute for Agricultural Research
ClinicalTrials.gov Identifier:	NCT00617435

Purpose

The investigators' project has as for principal objective to understand the impact of trans fatty acids from dairy products and industrial origin on the development of insulin resistance in obese woman. Because of the different isomeric position of the double bound those trans fatty acids may have different metabolic effects.

Condition	Intervention
Insulin Resistance Obesity	Dietary Supplement: vaccenic acid enriched diet Dietary Supplement: Elaidic acid enriched diet Dietary Supplement: control diet

MedlinePlus related topics: Obesity

Drug Information available for: Insulin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Parallel Assignment

Further study details as provided by French National Institute for Agricultural Research:

Primary Outcome Measures:

Measure of insulin sensitivity by an hyperinsulinemic- euglycemic clamp. [ Time Frame: before and after 4 weeks of diets. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Muscle and adipose tissue biopsies and Body composition [ Time Frame: before and after 4 weeks of diet ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	66
Study Start Date:	October 2007
Study Completion Date:	January 2009
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
V: Experimental	Dietary Supplement: vaccenic acid enriched diet The experimental milk fat, entitled "vaccenic acid enriched milk fat" (VAMF), has been obtained by feeding cows with a diet containing sunflower oil.
N: Experimental	Dietary Supplement: Elaidic acid enriched diet Mixture of vegetable oils (including partially hydrogenated oils)
J: Experimental	Dietary Supplement: control diet Mixed of different oil

Detailed Description:

Women will be included in the study according to their susceptibility to develop a insulin resistance (evaluated starting from the body index of mass IMC superior to 28 kg.m-², of the waist measurement 88 cm). Once included in the study, the volunteers will receive for 4 weeks butter, dairy products and biscuits enriched in stearic, elaidic or vaccenic acid. The volunteers will undergo a measurement of the body composition by biphotonic absorptiometry as well as a complete metabolic assessment (blood and urinary samples, clamp to insulin and biopsies).

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

female
waist measurement > 88 cm
body mass index> 28kg/m2
Affiliated to National Health Insurance
Subject giving his/her written informed consent
Subject willing to comply with the study procedures
Subject considered as normal after clinical examination and medical questionnaire

Exclusion Criteria:

Reported food allergies
Currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study
Hepatic or renal impairments
Positive serologies to HIV or HCV, determined on blood sample
pregnant or presently attempting to get pregnant or menopause or lactating Blood donation done less than 2 months before the start of the study
Chronic pathologies: diabetes, hypertriglyceridemia, hypertension, cardiovascular diseases, chronic inflammatory diseases
Intestine, cardiovascular, kidney and cancer pathologies in the last 5 years
Previous heavy intestine surgery (except appendicectomy)
Previous medical and/or surgery judged by the investigator as incompatible with this study
High variation (> 5%) of body weight during the last 3 months
Consuming nutritional supplements which could interfered with lipid metabolism (fish oil capsule, vitamins, soja lecithins,…)
Heavy consumer of alcohol
Smoker or ex-smoker who stopped smoking less than 1 month before V0 (more than 5 cigarettes/dy).
Practising intensive physical exercise (> 5 h per week)
Vegetarian or vegan
Being under someone's supervision
Refusal to be registered on the National Volunteers Data file
Disliking butter, margarine, cheese, biscuits and/or vegetable oil
Dietary habits unreliable to controlled food intake
Being in exclusion on the National Volunteers Data file

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00617435

Locations

France
Centre de Recherche en Nutrition Humaine Auvergne
CLERMONT FERRAND, France, 63000
Centre de Recherche en Nutrition Humaine Rhônes-Alpes
LYON, France, 69000

Sponsors and Collaborators

French National Institute for Agricultural Research

Investigators

Principal Investigator:

Yves Boirie, MD, PU-PH

UMR1019 INRA - Université Clermont1

More Information

Related Info This link exits the ClinicalTrials.gov site

Publications:

Chardigny JM, Malpuech-Brugere C, Dionisi F, Bauman DE, German B, Mensink RP, Combe N, Chaumont P, Barbano DM, Enjalbert F, Bezelgues JB, Cristiani I, Moulin J, Boirie Y, Golay PA, Giuffrida F, Sebedio JL, Destaillats F. Rationale and design of the TRANSFACT project phase I: a study to assess the effect of the two different dietary sources of trans fatty acids on cardiovascular risk factors in humans. Contemp Clin Trials. 2006 Aug;27(4):364-73. Epub 2006 Apr 24.

Responsible Party:	UMR1019 INRA - Université Clermont1 ( Yves Boirie, MD, PU-PH )
Study ID Numbers:	2006-A00397-44, AU679, 2006-0132
Study First Received:	February 5, 2008
Last Updated:	January 14, 2009
ClinicalTrials.gov Identifier:	NCT00617435
Health Authority:	France: Ministry of Health

Keywords provided by French National Institute for Agricultural Research:

Trans fatty acid
Insulin resistance
Skeletal muscle
Adipose tissue

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Hyperinsulinism
Obesity
Metabolic Diseases
Nutrition Disorders

Overweight
Overnutrition
Insulin Resistance
Metabolic disorder
Glucose Metabolism Disorders
Insulin

ClinicalTrials.gov processed this record on February 09, 2009