NCT00439582

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2005

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 21, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 23, 2007

Completed
Last Updated

November 21, 2025

Status Verified

March 1, 2009

First QC Date

February 21, 2007

Last Update Submit

November 18, 2025

Conditions

Cardiovascular Disease

Keywords

LipoproteinsMilk fatPublic health nutritiontrans fatty acid

Outcome Measures

Primary Outcomes (1)

  • HDL-Cholesterol (HDL-C) levels.

Secondary Outcomes (9)

  • Triglycerides

  • Total cholesterol

  • Apo A1

  • Apo B

  • Factor VII

  • +4 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL
Dietary Supplement: vaccenic acid enriched milk fat (VAMF) [Transfact1]

2

EXPERIMENTAL
Dietary Supplement: hydrogenated oil

Interventions

vaccenic acid enriched milk fat (VAMF) [Transfact1]DIETARY_SUPPLEMENT
1
hydrogenated oilDIETARY_SUPPLEMENT

Partially hydrogenated vegetable oils (PHVO) and vegetable oils and fats

2

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • HDL cholesterol, g/L \> 0.4
  • Triacylglycerol g/L \<1.50
  • LDL Cholesterol g/L \<1.60
  • Affiliated to National Health Insurance
  • Waist size \< 102 cm (men) or 88 cm (women)
  • Normal blood pressure (diastolic \<90 mm Hg, systolic \<140 mm Hg)
  • Normal liver functions (γ-GT, transaminases, alkaline phosphatase)
  • Normal white blood cells count (4-10 g/L)
  • For women: effective contraception
  • Subject giving his/her written informed consent
  • Subject willing to comply with the study procedures
  • Subject considered as normal after clinical examination and medical questionnaire

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, determined on blood sample
  • For women, pregnant or presently attempting to get pregnant (-HCG blood test) or menopause or lactating
  • Blood donation done less than 2 months before the start of the study
  • Chronic pathologies: diabetes (fasted glycaemia \> 6,1 mmol/L), hypertriglyceridemia (≥1.50 g/L), hypertension (systolic blood pressure ≥ 140 mm Hg and/or diastolic blood pressure ≥ 90 mm Hg), cardiovascular diseases, chronic inflammatory diseases
  • Intestine, cardiovascular, kidney and cancer pathologies in the last 5 years
  • Previous heavy intestine surgery (except appendicectomy)
  • Previous medical and/or surgery judged by the investigator as incompatible with this study
  • High variation (\> 5%) of body weight during the last 3 months
  • Consuming nutritional supplements which could interfered with lipid metabolism (fish oil capsule, vitamins, soja lecithins,…)
  • Heavy consumer of alcohol (evaluated thanks to the values of the following hepatic enzymes: -GT, ASAT, ALAT)
  • Smoker or ex-smoker who stopped smoking less than 1 month before V0
  • Practicing intensive physical exercise (\> 3 h per week)
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Clermont-Ferrand, 63009, France

Location

Related Publications (1)

  • Chardigny JM, Malpuech-Brugere C, Dionisi F, Bauman DE, German B, Mensink RP, Combe N, Chaumont P, Barbano DM, Enjalbert F, Bezelgues JB, Cristiani I, Moulin J, Boirie Y, Golay PA, Giuffrida F, Sebedio JL, Destaillats F. Rationale and design of the TRANSFACT project phase I: a study to assess the effect of the two different dietary sources of trans fatty acids on cardiovascular risk factors in humans. Contemp Clin Trials. 2006 Aug;27(4):364-73. doi: 10.1016/j.cct.2006.03.003. Epub 2006 Apr 24.

    PMID: 16632411BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

polyethoxylated castor oil

Study Officials

  • Yves Boirie, MD, PU-PH

    UMR1019 INRA - Université Clermont1

    PRINCIPAL INVESTIGATOR

  • Jean-Michel Chardigny, PhD

    UMR 1019 INRA - Université Clermont1

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2007

First Posted

February 23, 2007

Study Start

August 1, 2005

Study Completion

December 1, 2005

Last Updated

November 21, 2025

Record last verified: 2009-03

Locations

FR(1)