title: 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.
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).
  
  
  METHODS
  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 (approximately 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: INRA-Université d'Auvergne, Clermont-Ferrand, France.
authors.forename: Jean-Michel
authors.initials: JM
authors.lastname: Chardigny
authors.forename: Corinne
authors.initials: C
authors.lastname: Malpuech-Brugère
authors.forename: Fabiola
authors.initials: F
authors.lastname: Dionisi
authors.forename: Dale E
authors.initials: DE
authors.lastname: Bauman
authors.forename: Bruce
authors.initials: B
authors.lastname: German
authors.forename: Ronald P
authors.initials: RP
authors.lastname: Mensink
authors.forename: Nicole
authors.initials: N
authors.lastname: Combe
authors.forename: Patrice
authors.initials: P
authors.lastname: Chaumont
authors.forename: David M
authors.initials: DM
authors.lastname: Barbano
authors.forename: Francis
authors.initials: F
authors.lastname: Enjalbert
authors.forename: Jean-Baptiste
authors.initials: JB
authors.lastname: Bezelgues
authors.forename: Isabelle
authors.initials: I
authors.lastname: Cristiani
authors.forename: Julie
authors.initials: J
authors.lastname: Moulin
authors.forename: Yves
authors.initials: Y
authors.lastname: Boirie
authors.forename: Pierre-Alain
authors.initials: PA
authors.lastname: Golay
authors.forename: Francesca
authors.initials: F
authors.lastname: Giuffrida
authors.forename: Jean-Louis
authors.initials: JL
authors.lastname: Sébédio
authors.forename: Frédéric
authors.initials: F
authors.lastname: Destaillats
mesh_terms: D000328:Adult; D002318:Cardiovascular Diseases / Q000097:blood / Q000178:diet therapy*; D008076:Cholesterol, HDL / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D012307:Risk Factors; D044242:Trans Fatty Acids / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D044242:Trans Fatty Acids