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

March 13, 2009 updated by: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

Rationale, Study Design and Baseline Data of the TRANSQUAL Clinical Trial: A Study to Evaluate the Impact of Different Milk Fatty Acid Profiles on Cardiovascular Risk Factors in Healthy Volunteers; Focus on Trans Fatty Acids

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

107

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63009
        • Centre de Recherche en Nutrition Humaine (CRNH), UEN, Laboratoire de Nutrition Humaine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
HDL-cholesterol

Secondary Outcome Measures

Outcome Measure
LDL-cholesterol
total cholesterol
triglycerides
apolipoprotein

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Yves Boirie, MD, PhD, PU-PH, UMR1019 INRA-Université Clermont1
  • Study Director: Jean-Michel Chardigny, PhD, UMR1019 INRA-Université Clermont1

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

May 23, 2008

First Submitted That Met QC Criteria

May 27, 2008

First Posted (Estimate)

May 28, 2008

Study Record Updates

Last Update Posted (Estimate)

March 16, 2009

Last Update Submitted That Met QC Criteria

March 13, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AU684

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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