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

NCT ID: NCT00617435

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2009-01-31

Brief Summary

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.

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).

Conditions

Insulin Resistance; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

V

Group Type: EXPERIMENTAL

vaccenic acid enriched diet

Intervention Type: DIETARY_SUPPLEMENT

The experimental milk fat, entitled "vaccenic acid enriched milk fat" (VAMF), has been obtained by feeding cows with a diet containing sunflower oil.

N

Group Type: EXPERIMENTAL

Elaidic acid enriched diet

Intervention Type: DIETARY_SUPPLEMENT

Mixture of vegetable oils (including partially hydrogenated oils)

J

Group Type: EXPERIMENTAL

control diet

Intervention Type: DIETARY_SUPPLEMENT

Mixed of different oil

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Elaidic acid enriched diet

Mixture of vegetable oils (including partially hydrogenated oils)

Intervention Type: DIETARY_SUPPLEMENT

control diet

Mixed of different oil

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yves Boirie, MD, PU-PH

Role: PRINCIPAL_INVESTIGATOR

UMR1019 INRA - Université Clermont1

Locations

Centre de Recherche en Nutrition Humaine Auvergne

Clermont-Ferrand, , France

Centre de Recherche en Nutrition Humaine Rhônes-Alpes

Lyon, , France

Countries

France

References

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. doi: 10.1016/j.cct.2006.03.003. Epub 2006 Apr 24.

Reference Type: BACKGROUND

PMID: 16632411 (View on PubMed)

Tardy AL, Lambert-Porcheron S, Malpuech-Brugere C, Giraudet C, Rigaudiere JP, Laillet B, Leruyet P, Peyraud JL, Boirie Y, Laville M, Michalski MC, Chardigny JM, Morio B. Dairy and industrial sources of trans fat do not impair peripheral insulin sensitivity in overweight women. Am J Clin Nutr. 2009 Jul;90(1):88-94. doi: 10.3945/ajcn.2009.27515. Epub 2009 May 27.

Reference Type: DERIVED

PMID: 19474135 (View on PubMed)

Other Identifiers

AU679

Identifier Type: -

Identifier Source: secondary_id

2006-0132

Identifier Type: -

Identifier Source: secondary_id

2006-A00397-44

Identifier Type: -

Identifier Source: org_study_id