NCT00617435

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2007

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 18, 2008

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

November 24, 2025

Status Verified

March 1, 2009

Enrollment Period

2 months

First QC Date

February 5, 2008

Last Update Submit

November 19, 2025

Conditions

Insulin ResistanceObesity

Keywords

Trans fatty acidInsulin resistanceSkeletal muscleAdipose tissue

Outcome Measures

Primary Outcomes (1)

  • Measure of insulin sensitivity by an hyperinsulinemic- euglycemic clamp.

    before and after 4 weeks of diets.

Secondary Outcomes (1)

  • Muscle and adipose tissue biopsies and Body composition

    before and after 4 weeks of diet

Study Arms (3)

V

EXPERIMENTAL
Dietary Supplement: vaccenic acid enriched diet

N

EXPERIMENTAL
Dietary Supplement: Elaidic acid enriched diet

J

EXPERIMENTAL
Dietary Supplement: control diet

Interventions

vaccenic acid enriched dietDIETARY_SUPPLEMENT

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

V
Elaidic acid enriched dietDIETARY_SUPPLEMENT

Mixture of vegetable oils (including partially hydrogenated oils)

N
control dietDIETARY_SUPPLEMENT

Mixed of different oil

J

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre de Recherche en Nutrition Humaine Auvergne

Clermont-Ferrand, 63000, France

Location

Centre de Recherche en Nutrition Humaine Rhônes-Alpes

Lyon, 69000, France

Location

Related Publications (2)

  • 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.

    PMID: 16632411BACKGROUND

  • 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.

    PMID: 19474135DERIVED

MeSH Terms

Conditions

Insulin ResistanceObesity

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Yves Boirie, MD, PU-PH

    UMR1019 INRA - Université Clermont1

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2008

First Posted

February 18, 2008

Study Start

October 1, 2007

Primary Completion

December 1, 2007

Study Completion

January 1, 2009

Last Updated

November 24, 2025

Record last verified: 2009-03

Locations

FR(2)