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

Obesity Clinical Trial

— Trans-Insulin  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00617435
• Other study ID #: 2006-A00397-44
• Secondary ID: AU6792006-0132
• Status: Completed
• Phase: N/A
• First received: February 5, 2008
• Last updated: March 13, 2009
• Start date: October 2007
• Est. completion date: January 2009

Study information

• Verified date: March 2009
• Source: Institut National de la Recherche Agronomique
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: January 2009
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Insulin Resistance
• Obesity

Intervention

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.
• Elaidic acid enriched diet
Mixture of vegetable oils (including partially hydrogenated oils)
• control diet
Mixed of different oil

Locations

Country	Name	City	State
France	Centre de Recherche en Nutrition Humaine Auvergne	Clermont Ferrand
France	Centre de Recherche en Nutrition Humaine Rhônes-Alpes	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Recherche Agronomique

Country where clinical trial is conducted

France, 

References & Publications (1)

Chardigny JM, Malpuech-Brugère 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, Sébédio 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. Epub 2006 Apr 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of insulin sensitivity by an hyperinsulinemic- euglycemic clamp.		before and after 4 weeks of diets.	Yes
Secondary	Muscle and adipose tissue biopsies and Body composition		before and after 4 weeks of diet	Yes