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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Cardiovascular Disease

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>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<br>* the lowest R-TFA/SFA ratio obtained from dairy cows in Winter period<br>|
| Experimental: B<br>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<br>* the medium R-TFA/SFA ratio obtained from dairy cows feeding with Winter diet supplemented with 4.1% flax seed<br>|
| Experimental: C<br>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<br>* the highest R-TFA/SFA ratio obtained from dairy cows feeding with Winter diet supplemented with 9% flax seed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HDL-cholesterol |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total cholesterol |  |  | 
| LDL-cholesterol |  |  | 
| triglycerides |  |  | 
| apolipoprotein |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TFA, SFA, Clinical trial, fat milk