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

NCT00685581 | Completed DMC

• 1 other identifier: AU684
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiovascular Disease

Keywords

TFA; SFA; Clinical trial; fat milk

Outcome Measures

Primary Outcomes (1)

• HDL-cholesterol

Secondary Outcomes (4)

• total cholesterol

• LDL-cholesterol

• triglycerides

• apolipoprotein

Study Arms (3)

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

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

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

Interventions

Ruminant trans fatty acid enriched diet - lowest ratio DIETARY_SUPPLEMENT

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

A

Ruminant trans fatty acid enriched diet - medium ratio DIETARY_SUPPLEMENT

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

B

Ruminant trans fatty acid enriched diet - highest ratio DIETARY_SUPPLEMENT

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

C

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Centre de Recherche en Nutrition Humaine (CRNH), UEN, Laboratoire de Nutrition Humaine

Clermont-Ferrand, 63009, France

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Yves Boirie, MD, PhD, PU-PH

  UMR1019 INRA-Université Clermont1

  PRINCIPAL INVESTIGATOR

• Jean-Michel Chardigny, PhD

  UMR1019 INRA-Université Clermont1

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2008
• First Posted: May 28, 2008
• Study Start: April 1, 2007
• Study Completion: May 1, 2008
• Last Updated: October 6, 2025

Record last verified: 2025-10

Locations

FR (1)