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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; 27(4):364-73CC

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 (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.

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.

Authors+Show Affiliations

INRA-Université d'Auvergne, Clermont-Ferrand, France.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase I
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16632411

Citation

Chardigny, Jean-Michel, et al. "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, vol. 27, no. 4, 2006, pp. 364-73.
Chardigny JM, Malpuech-Brugère C, Dionisi F, et al. 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;27(4):364-73.
Chardigny, J. M., Malpuech-Brugère, C., Dionisi, F., Bauman, D. E., German, B., Mensink, R. P., ... 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), pp. 364-73.
Chardigny JM, et al. 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;27(4):364-73. PubMed PMID: 16632411.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Chardigny,Jean-Michel, AU - Malpuech-Brugère,Corinne, AU - Dionisi,Fabiola, AU - Bauman,Dale E, AU - German,Bruce, AU - Mensink,Ronald P, AU - Combe,Nicole, AU - Chaumont,Patrice, AU - Barbano,David M, AU - Enjalbert,Francis, AU - Bezelgues,Jean-Baptiste, AU - Cristiani,Isabelle, AU - Moulin,Julie, AU - Boirie,Yves, AU - Golay,Pierre-Alain, AU - Giuffrida,Francesca, AU - Sébédio,Jean-Louis, AU - Destaillats,Frédéric, Y1 - 2006/04/24/ PY - 2005/11/25/received PY - 2006/01/10/revised PY - 2006/03/12/accepted PY - 2006/4/25/pubmed PY - 2006/11/15/medline PY - 2006/4/25/entrez SP - 364 EP - 73 JF - Contemporary clinical trials JO - Contemp Clin Trials VL - 27 IS - 4 N2 - 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 (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. 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. SN - 1551-7144 UR - https://www.unboundmedicine.com/medline/citation/16632411/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_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1551-7144(06)00025-5 DB - PRIME DP - Unbound Medicine ER -