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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00685581

Acronym

TRANSQUAL WPC

Enrollment

107

Registered

2008-05-28

Start date

2007-04-30

Completion date

2008-05-31

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease

Keywords

TFA, SFA, Clinical trial, fat milk

Brief summary

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

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.

Interventions

DIETARY_SUPPLEMENTRuminant trans fatty acid enriched diet - lowest ratio

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

DIETARY_SUPPLEMENTRuminant 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

DIETARY_SUPPLEMENTRuminant 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
HDL-cholesterol	—

Secondary

Measure	Time frame
total cholesterol	—
LDL-cholesterol	—
triglycerides	—
apolipoprotein	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026