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

Primary Purpose

Insulin Resistance, Obesity

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
vaccenic acid enriched diet
Elaidic acid enriched diet
control diet
Sponsored by
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Insulin Resistance focused on measuring Trans fatty acid, Insulin resistance, Skeletal muscle, Adipose tissue

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Centre de Recherche en Nutrition Humaine Auvergne
  • Centre de Recherche en Nutrition Humaine Rhônes-Alpes

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

V

N

J

Arm Description

Outcomes

Primary Outcome Measures

Measure of insulin sensitivity by an hyperinsulinemic- euglycemic clamp.

Secondary Outcome Measures

Muscle and adipose tissue biopsies and Body composition

Full Information

First Posted
February 5, 2008
Last Updated
March 13, 2009
Sponsor
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
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1. Study Identification

Unique Protocol Identification Number
NCT00617435
Brief Title
Impact of Trans Fatty Acids From Natural and Industrial Origin in the Induction of Insulin Resistance Development
Acronym
Trans-Insulin
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance, Obesity
Keywords
Trans fatty acid, Insulin resistance, Skeletal muscle, Adipose tissue

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
V
Arm Type
Experimental
Arm Title
N
Arm Type
Experimental
Arm Title
J
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
vaccenic acid enriched diet
Intervention Description
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
Intervention Name(s)
Elaidic acid enriched diet
Intervention Description
Mixture of vegetable oils (including partially hydrogenated oils)
Intervention Type
Dietary Supplement
Intervention Name(s)
control diet
Intervention Description
Mixed of different oil
Primary Outcome Measure Information:
Title
Measure of insulin sensitivity by an hyperinsulinemic- euglycemic clamp.
Time Frame
before and after 4 weeks of diets.
Secondary Outcome Measure Information:
Title
Muscle and adipose tissue biopsies and Body composition
Time Frame
before and after 4 weeks of diet

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yves Boirie, MD, PU-PH
Organizational Affiliation
UMR1019 INRA - Université Clermont1
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre de Recherche en Nutrition Humaine Auvergne
City
Clermont Ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
Centre de Recherche en Nutrition Humaine Rhônes-Alpes
City
Lyon
ZIP/Postal Code
69000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
16632411
Citation
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.
Results Reference
background
PubMed Identifier
19474135
Citation
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.
Results Reference
derived

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

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