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

This study has been completed.
Sponsor:
Information provided by:
Institut National de la Recherche Agronomique
ClinicalTrials.gov Identifier:
NCT00685581
First received: May 23, 2008
Last updated: March 13, 2009
Last verified: March 2009
  Purpose

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.


Condition Intervention
Cardiovascular Disease
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Institut National de la Recherche Agronomique:

Primary Outcome Measures:
  • HDL-cholesterol

Secondary Outcome Measures:
  • total cholesterol
  • LDL-cholesterol
  • triglycerides
  • apolipoprotein

Enrollment: 107
Study Start Date: April 2007
Study Completion Date: May 2008
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00685581

Locations
France
Centre de Recherche en Nutrition Humaine (CRNH), UEN, Laboratoire de Nutrition Humaine
Clermont-Ferrand, France, 63009
Sponsors and Collaborators
Institut National de la Recherche Agronomique
Investigators
Principal Investigator: Yves Boirie, MD, PhD, PU-PH UMR1019 INRA-Université Clermont1
Study Director: Jean-Michel Chardigny, PhD UMR1019 INRA-Université Clermont1
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00685581     History of Changes
Other Study ID Numbers: AU684
Study First Received: May 23, 2008
Last Updated: March 13, 2009
Health Authority: France: Ministry of Health

Keywords provided by Institut National de la Recherche Agronomique:
TFA
SFA
Clinical trial
fat milk

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 16, 2014