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

This study has been completed.
Sponsor:
Information provided by:
Institut National de la Recherche Agronomique
ClinicalTrials.gov Identifier:
NCT00617435
First received: February 5, 2008
Last updated: March 13, 2009
Last verified: March 2009
History of Changes
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Institut National de la Recherche Agronomique:

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
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

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

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Yves Boirie, MD, PU-PH, UMR1019 INRA - Université Clermont1
ClinicalTrials.gov Identifier: NCT00617435     History of Changes
Other Study ID Numbers: 2006-A00397-44, AU679, 2006-0132
Study First Received: February 5, 2008
Last Updated: March 13, 2009
Health Authority: France: Ministry of Health

Keywords provided by Institut National de la Recherche Agronomique:
Trans fatty acid
Insulin resistance
Skeletal muscle
Adipose tissue

Additional relevant MeSH terms:
Insulin Resistance
Obesity
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
 Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013