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Completed

NCT Number: NCT00685581

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

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.

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Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Clermont-Ferrand, 63009, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ruminant trans fatty acid enriched diet - lowest ratio

Dietary Supplement

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

Ruminant trans fatty acid enriched diet - medium ratio

Dietary Supplement

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

Ruminant trans fatty acid enriched diet - highest ratio

Dietary Supplement

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

Primary outcomes

  1. HDL-cholesterol

Secondary outcomes

  1. total cholesterol

  2. LDL-cholesterol

  3. triglycerides

  4. apolipoprotein

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study 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

Acronym: TRANSQUAL WPC

Important dates

Study start
2007
Study completion
2008
First posted
May 28, 2008
Registry last updated
Oct 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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