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

Sponsored by:	Institut National de la Recherche Agronomique
Information provided by:	Institut National de la Recherche Agronomique
ClinicalTrials.gov Identifier:	NCT00685581

Purpose

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.

Condition	Intervention
Cardiovascular Disease	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

MedlinePlus related topics: Cholesterol Dietary Supplements Diets

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy 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

Further study details as provided by Institut National de la Recherche Agronomique:

Primary Outcome Measures:

HDL-cholesterol

Secondary Outcome Measures:

total cholesterol
LDL-cholesterol
triglycerides
apolipoprotein

Enrollment:	107
Study Start Date:	April 2007
Study Completion Date:	May 2008

Arms	Assigned Interventions
A: Experimental 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 the lowest R-TFA/SFA ratio obtained from dairy cows in Winter period
B: Experimental 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 the medium R-TFA/SFA ratio obtained from dairy cows feeding with Winter diet supplemented with 4.1% flax seed
C: Experimental 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 the highest R-TFA/SFA ratio obtained from dairy cows feeding with Winter diet supplemented with 9% flax seed

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.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00685581

Locations

France
Centre de Recherche en Nutrition Humaine (CRNH), UEN, Laboratoire de Nutrition Humaine
Clermont-Ferrand, France, 63009

Sponsors and Collaborators

Institut National de la Recherche Agronomique

Investigators

Principal Investigator:	Yves Boirie, MD, PhD, PU-PH	UMR1019 INRA-Université Clermont1
Study Director:	Jean-Michel Chardigny, PhD	UMR1019 INRA-Université Clermont1

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	AU684
Study First Received:	May 23, 2008
Last Updated:	March 13, 2009
ClinicalTrials.gov Identifier:	NCT00685581 History of Changes
Health Authority:	France: Ministry of Health

Keywords provided by Institut National de la Recherche Agronomique:

TFA
SFA
Clinical trial
fat milk

Study placed in the following topic categories:

Healthy

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 07, 2009