NCT00439582: TRANSFACT1

Comparative Effect of 2 Different Sources of Trans Fatty Acid (Milk Fat vs Hydrogenated Oil)on Cardiovascular Risk Factors in Healthy Humans

Completed NA Last updated 18 November 2025

What this trial tests

NA trial testing vaccenic acid enriched milk fat (VAMF) [Transfact1] in Cardiovascular Disease in 46 participants. Completed in 1 December 2005.

Timeline

1 August 2005

1 December 2005

Quick facts

Lead sponsor	Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	prevention
Enrollment	46
Start date	1 August 2005
Estimated completion	1 December 2005
Sites	1 location across France

Drugs / interventions tested

• vaccenic acid enriched milk fat (VAMF) [Transfact1]
• hydrogenated oil

Conditions studied

• Cardiovascular Disease — all drugs for Cardiovascular Disease →

Sponsor

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

Who can join

Adults 18 to 50, any sex, with Cardiovascular Disease. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• HDL-Cholesterol (HDL-C) levels.

Sponsor's own description

Background:

Detrimental effects of consumption of industrial trans fatty acids (TFA) from partially hydrogenated vegetable oils (PHVO) on cardiovascular disease (CVD) risk factors are well documented. However, very little information is available on the effect of natural sources of TFA coming from milk fat, dairy products and ruminant meat. In fact, due to the naturally low level of TFA in milk fat, it is almost impossible to conduct a clinical trial with a limited number of subjects.

Methodology:

To compare the effects of industrial and natural dietary sources of TFA, two specific test fats have been designed and produced. A substantial amount of milk fat (130 kg) enriched in TFA has been produced by modification of the cow's diet and selection of cows with the highest TFA content. The level obtained was approximately 4- to 7-fold higher than typically present in milk fat ( - 20 instead of 3-6 g/100 g of total fatty acids). The control fat is composed of PHVO balanced in saturated fatty acids (lauric, myristic and palmitic). Both experimental fats contain about 20-22% of monounsaturated TFA and the volunteers' daily experimental fat intake (54 g), will represent about 12.0 g/day of TFA or 5.4% of the daily energy (based on 2000 kcal/day). These two test fats have been incorporated into food items and will be provided to 46 healthy subjects under a randomised, double blind, controlled, cross-over design. The primary outcome is high-density lipoprotein cholesterol (HDL-C), which is an independent risk factor for CVD. Other parameters such as lipoprotein cholesterol (LDL-C), very low-density lipoprotein cholesterol (VLDL-C), and HDL-C level and subclasses will be also to be evaluated.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.