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

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

Status: Completed

Conditions: Cardiovascular Disease

Treatments: Dietary Supplement: Ruminant trans fatty acid enriched diet - medium ratio; Dietary Supplement: Ruminant trans fatty acid enriched diet - lowest ratio; Dietary Supplement: Ruminant trans fatty acid enriched diet - highest ratio

Study type: Interventional

Funder types: Other

Identifiers

NCT00685581

AU684

Details and patient eligibility

About

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.

Full 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.

Enrollment: 107 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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107 participants in 3 patient groups

A

Experimental group

Description:

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

Treatment:

Dietary Supplement: Ruminant trans fatty acid enriched diet - lowest ratio

B

Experimental group

Description:

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

Treatment:

Dietary Supplement: Ruminant trans fatty acid enriched diet - medium ratio

C

Experimental group

Description:

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

Treatment:

Dietary Supplement: Ruminant trans fatty acid enriched diet - highest ratio