Cardiovascular DiseaseTRANSQUAL WPCNCT00685581
Impact of Vaccenic Acid Consumption on the Metabolism of Saturated Fatty Acids: Relationship With Cardiovascular Risk Factors
A study testing Ruminant trans fatty acid enriched diet - lowest ratio, Ruminant trans fatty acid enriched diet - medium ratio and Ruminant trans fatty acid enriched diet - highest ratio in people with Cardiovascular Disease, run by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Ruminant trans fatty acid enriched diet - lowest ratio, Ruminant trans fatty acid enriched diet - medium ratio and Ruminant trans fatty acid enriched diet - highest ratio
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2007to May 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
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- For women: effective contraception
- Subject giving his/her written informed consent
- Subject willing to comply with the study procedures
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Centre de Recherche en Nutrition Humaine (CRNH), UEN, Laboratoire de Nutrition Humaine
Clermont-Ferrand, 63009
About this study
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
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.
Read the 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.
- Conditions
- Cardiovascular Disease
- Being tested
- Ruminant trans fatty acid enriched diet - lowest ratio, Ruminant trans fatty acid enriched diet - medium ratio, Ruminant trans fatty acid enriched diet - highest ratio
- Keywords
- TFA, SFA, Clinical trial, fat milk
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ruminant trans fatty acid enriched diet - lowest ratioDietary supplement
the lowest R-TFA/SFA ratio obtained from dairy cows in Winter period
Ruminant trans fatty acid enriched diet - medium ratioDietary 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 ratioDietary supplement
the highest R-TFA/SFA ratio obtained from dairy cows feeding with Winter diet supplemented with 9% flax seed
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Arms A: the lowest R-TFA/SFA ratio obtained from dairy cows in Winter period Receives: Dietary Supplement: Ruminant trans fatty acid enriched diet - lowest ratio |
| B | Experimental | Arms B: the medium R-TFA/SFA ratio obtained from dairy cows feeding with Winter diet supplemented with 4.1% flax seed. Receives: Dietary Supplement: Ruminant trans fatty acid enriched diet - medium ratio |
| C | Experimental | Arms C: the highest R-TFA/SFA ratio obtained from dairy cows feeding with Winter diet supplemented with 9% flax seed. Receives: Dietary Supplement: Ruminant trans fatty acid enriched diet - highest ratio |
What is being measured
The primary outcome is the main question the study is designed to answer.
HDL-cholesterol
Secondary outcomes (4)
total cholesterol
LDL-cholesterol
triglycerides
apolipoprotein
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2008 (estimated)
- Study startApr 2007
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yves Boirie, MD, PhD, PU-PH, Principal investigator, UMR1019 INRA-Université Clermont1Jean-Michel Chardigny, PhD, Study director, UMR1019 INRA-Université Clermont1
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00685581
- Sponsor's protocol ID
- AU684
- Acronym
- TRANSQUAL WPC
- Status last verified
- Oct 2025
- First submitted
- 23 May 2008
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00685581
- Acronym / sponsor ID
- TRANSQUAL WPC / AU684
- Conditions
- Cardiovascular Disease
- Keywords
- TFA, SFA, Clinical trial, fat milk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'EnvironnementUniversity, hospital or other
- Study start
- Apr 2007
- Study completion
- May 2008 (actual)
- First posted
- 28 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Dietary Supplement: Ruminant trans fatty acid enriched diet - lowest ratioArms A: the lowest R-TFA/SFA ratio obtained from dairy cows in Winter period |
| B | Experimental | Dietary Supplement: Ruminant trans fatty acid enriched diet - medium ratioArms B: the medium R-TFA/SFA ratio obtained from dairy cows feeding with Winter diet supplemented with 4.1% flax seed. |
| C | Experimental | Dietary Supplement: Ruminant trans fatty acid enriched diet - highest ratioArms C: the highest R-TFA/SFA ratio obtained from dairy cows feeding with Winter diet supplemented with 9% flax seed. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ruminant trans fatty acid enriched diet - lowest ratiothe lowest R-TFA/SFA ratio obtained from dairy cows in Winter period | Dietary supplement | A |
| Ruminant trans fatty acid enriched diet - medium ratiothe medium R-TFA/SFA ratio obtained from dairy cows feeding with Winter diet supplemented with 4.1% flax seed | Dietary supplement | B |
| Ruminant trans fatty acid enriched diet - highest ratiothe highest R-TFA/SFA ratio obtained from dairy cows feeding with Winter diet supplemented with 9% flax seed | Dietary supplement | C |
Primary outcome
HDL-cholesterol
4 secondary outcomes
total cholesterol
LDL-cholesterol
triglycerides
apolipoprotein
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yves Boirie, MD, PhD, PU-PH principal investigator
UMR1019 INRA-Université Clermont1
Jean-Michel Chardigny, PhD study director
UMR1019 INRA-Université Clermont1
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ruminant trans fatty acid enriched diet - lowest ratio, Ruminant trans fatty acid enriched diet - medium ratio and Ruminant trans fatty acid enriched diet - highest ratio in people with Cardiovascular Disease, run by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HDL-cholesterol. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.