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

Cardiovascular Disease Clinical Trial

— TRANSQUAL WPC  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00685581
• Other study ID #: AU684
• Status: Completed
• Phase: N/A
• First received: May 23, 2008
• Last updated: March 13, 2009
• Start date: April 2007
• Est. completion date: May 2008

Study information

• Verified date: March 2009
• Source: Institut National de la Recherche Agronomique
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Dietary Supplement:
• Ruminant trans fatty acid enriched diet - lowest ratio
the lowest R-TFA/SFA ratio obtained from dairy cows in Winter period
• Ruminant 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
• Ruminant 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

Locations

Country	Name	City	State
France	Centre de Recherche en Nutrition Humaine (CRNH), UEN, Laboratoire de Nutrition Humaine	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Recherche Agronomique

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HDL-cholesterol
Secondary	total cholesterol
Secondary	LDL-cholesterol
Secondary	triglycerides
Secondary	apolipoprotein