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

November 19, 2025 updated by: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63000
        • Centre de Recherche en Nutrition Humaine Auvergne
      • Lyon, France, 69000
        • Centre de Recherche en Nutrition Humaine Rhônes-Alpes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: V
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.
Experimental: N
Dietary supplement: Elaidic acid enriched diet
Mixture of vegetable oils (including partially hydrogenated oils)
Experimental: J
Dietary supplement: control diet
Mixed of different oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measure of insulin sensitivity by an hyperinsulinemic- euglycemic clamp.
Time Frame: before and after 4 weeks of diets.
before and after 4 weeks of diets.

Secondary Outcome Measures

Outcome Measure
Time Frame
Muscle and adipose tissue biopsies and Body composition
Time Frame: before and after 4 weeks of diet
before and after 4 weeks of diet

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Yves Boirie, MD, PU-PH, UMR1019 INRA - Université Clermont1

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

February 5, 2008

First Submitted That Met QC Criteria

February 5, 2008

First Posted (Estimated)

February 18, 2008

Study Record Updates

Last Update Posted (Estimated)

November 24, 2025

Last Update Submitted That Met QC Criteria

November 19, 2025

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006-A00397-44
  • AU679
  • 2006-0132

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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