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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00617435
Recruitment Status : Completed
First Posted : February 18, 2008
Last Update Posted : March 16, 2009
Information provided by:
Institut National de la Recherche Agronomique

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.

Condition or disease Intervention/treatment Phase
Insulin Resistance Obesity Dietary Supplement: vaccenic acid enriched diet Dietary Supplement: Elaidic acid enriched diet Dietary Supplement: control diet Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Study Start Date : October 2007
Actual Primary Completion Date : December 2007
Actual Study Completion Date : January 2009

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

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

Secondary Outcome Measures :
  1. Muscle and adipose tissue biopsies and Body composition [ Time Frame: before and after 4 weeks of diet ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00617435

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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
Institut National de la Recherche Agronomique
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Principal Investigator: Yves Boirie, MD, PU-PH UMR1019 INRA - Université Clermont1

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Yves Boirie, MD, PU-PH, UMR1019 INRA - Université Clermont1 Identifier: NCT00617435    
Other Study ID Numbers: 2006-A00397-44
First Posted: February 18, 2008    Key Record Dates
Last Update Posted: March 16, 2009
Last Verified: March 2009
Keywords provided by Institut National de la Recherche Agronomique:
Trans fatty acid
Insulin resistance
Skeletal muscle
Adipose tissue
Additional relevant MeSH terms:
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Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Hypoglycemic Agents
Physiological Effects of Drugs