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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 01, 2014