Impact of Vaccenic Acid Consumption on the Metabolism of Saturated Fatty Acids: Relationship With Cardiovascular Risk Factors

Not Applicable

Completed

• Conditions: Cardiovascular Disease
• Interventions: Dietary Supplement: Ruminant trans fatty acid enriched diet - lowest ratio; Dietary Supplement: Ruminant trans fatty acid enriched diet - medium ratio; Dietary Supplement: Ruminant trans fatty acid enriched diet - highest ratio

• Registration Number: NCT00685581
• Lead Sponsor: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

Brief Summary

The investigators' project has for principal objective to evaluate the impact of three specific ruminant milk fats with a Trans Fatty Acid content ranging from 2.9% to 12.2% obtained by modification of the cow's diet on cardiovascular risk factors in healthy subjects.

Detailed Description

111 healthy, normolipemic men and women (18y to 50y) have been recruited for a monocentric, randomised, double-blind, controlled 4-week study. All the volunteers consumed 3 experimental products (butter, dessert cream and cakes) made with one of the 3 specific milk fats up to 55 g fat/day.

Study Timeline

• Study Start: 2007-04
• Study Completion: 2008-05
• Study First Submitted: 2008-05-23
• Study First Submitted QC: 2008-05-27
• Study First Posted: 2008-05-28
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-13
• Last Update Posted: 2009-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

Inclusion Criteria

• HDL cholesterol, g/L > 0.4
• Triacylglycerol g/L <1.50
• LDL Cholesterol g/L <1.60
• Waist size < 94 cm (men) or 80 cm (women)
• Affiliated to National Health Insurance
• Normal blood pressure (diastolic <90 mm Hg, systolic <140 mm Hg)
• For women: effective contraception
• Subject giving his/her written informed consent
• Subject willing to comply with the study procedures

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,
• Blood donation done less than 2 months before the start of the study
• Chronic pathologies
• Refusal to be registered on the National Volunteers Data file
• Being in exclusion on the National Volunteers Data file

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Ruminant trans fatty acid enriched diet - lowest ratio	Arms A: the lowest R-TFA/SFA ratio obtained from dairy cows in Winter period
B	Ruminant trans fatty acid enriched diet - medium ratio	Arms B: the medium R-TFA/SFA ratio obtained from dairy cows feeding with Winter diet supplemented with 4.1% flax seed.
C	Ruminant trans fatty acid enriched diet - highest ratio	Arms C: the highest R-TFA/SFA ratio obtained from dairy cows feeding with Winter diet supplemented with 9% flax seed.

Primary Outcome Measures

Name	Time	Method
HDL-cholesterol

Secondary Outcome Measures

Name	Time	Method
total cholesterol
LDL-cholesterol
triglycerides
apolipoprotein

Trial Locations

Locations (1)

Centre de Recherche en Nutrition Humaine (CRNH), UEN, Laboratoire de Nutrition Humaine; 🇫🇷 Clermont-Ferrand, France