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

Jean Michel Chardigny, Corinne Malpuech-Brugère, Fabiola Dionisi, Dale E. Bauman, Bruce German, Ronald P. Mensink, Nicole Combe, Patrice Chaumont, David M. Barbano, Francis Enjalbert, Jean Baptiste Bezelgues, Isabelle Cristiani, Julie Moulin, Yves Boirie, Pierre Alain Golay, Francesca Giuffrida, Jean Louis Sébédio, Frédéric Destaillats

Research output: Contribution to journalArticle

36 Scopus citations

Abstract

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 (< 200). 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 low-density lipoprotein cholesterol (LDL-C), very low-density lipoprotein cholesterol (VLDL-C), and HDL-C level and subclasses will be also to be evaluated. Conclusion: We have shown that it is technically feasible to perform a clinical trial on the comparative effects of natural and industrial sources of TFA isomers on CVD risk factors. Results are expected by mid-2006.

Original languageEnglish (US)
Pages (from-to)364-373
Number of pages10
JournalContemporary Clinical Trials
Volume27
Issue number4
DOIs
StatePublished - Aug 2006

Keywords

  • Cardiovascular disease
  • Milk fat
  • Public health nutrition
  • trans fatty acid

ASJC Scopus subject areas

  • Pharmacology

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    Chardigny, J. M., Malpuech-Brugère, C., Dionisi, F., Bauman, D. E., German, B., Mensink, R. P., Combe, N., Chaumont, P., Barbano, D. M., Enjalbert, F., Bezelgues, J. B., Cristiani, I., Moulin, J., Boirie, Y., Golay, P. A., Giuffrida, F., Sébédio, J. L., & Destaillats, F. (2006). 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. Contemporary Clinical Trials, 27(4), 364-373. https://doi.org/10.1016/j.cct.2006.03.003