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

NCT ID: NCT00685581

Last Updated: 2025-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2008-05-31

Brief Summary

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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

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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.

Conditions

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Cardiovascular Disease

Keywords

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TFA SFA Clinical trial fat milk

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A

Arms A: the lowest R-TFA/SFA ratio obtained from dairy cows in Winter period

Group Type EXPERIMENTAL

Ruminant trans fatty acid enriched diet - lowest ratio

Intervention Type DIETARY_SUPPLEMENT

the lowest R-TFA/SFA ratio obtained from dairy cows in Winter period

B

Arms B: the medium R-TFA/SFA ratio obtained from dairy cows feeding with Winter diet supplemented with 4.1% flax seed.

Group Type EXPERIMENTAL

Ruminant trans fatty acid enriched diet - medium ratio

Intervention Type DIETARY_SUPPLEMENT

the medium R-TFA/SFA ratio obtained from dairy cows feeding with Winter diet supplemented with 4.1% flax seed

C

Arms C: the highest R-TFA/SFA ratio obtained from dairy cows feeding with Winter diet supplemented with 9% flax seed.

Group Type EXPERIMENTAL

Ruminant trans fatty acid enriched diet - highest ratio

Intervention Type DIETARY_SUPPLEMENT

the highest R-TFA/SFA ratio obtained from dairy cows feeding with Winter diet supplemented with 9% flax seed

Interventions

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Ruminant trans fatty acid enriched diet - lowest ratio

the lowest R-TFA/SFA ratio obtained from dairy cows in Winter period

Intervention Type DIETARY_SUPPLEMENT

Ruminant trans fatty acid enriched diet - medium ratio

the medium R-TFA/SFA ratio obtained from dairy cows feeding with Winter diet supplemented with 4.1% flax seed

Intervention Type DIETARY_SUPPLEMENT

Ruminant trans fatty acid enriched diet - highest ratio

the highest R-TFA/SFA ratio obtained from dairy cows feeding with Winter diet supplemented with 9% flax seed

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yves Boirie, MD, PhD, PU-PH

Role: PRINCIPAL_INVESTIGATOR

UMR1019 INRA-Université Clermont1

Jean-Michel Chardigny, PhD

Role: STUDY_DIRECTOR

UMR1019 INRA-Université Clermont1

Locations

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Centre de Recherche en Nutrition Humaine (CRNH), UEN, Laboratoire de Nutrition Humaine

Clermont-Ferrand, , France

Site Status

Countries

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France

Other Identifiers

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AU684

Identifier Type: -

Identifier Source: org_study_id