Ruminant Trans Fats and the Risk of Cardiovascular Disease in Women

NCT ID: NCT00930137

Last Updated: 2013-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2011-09-30

Brief Summary

While the deleterious effects of trans fat from industrial sources (iTFA) on cardiovascular health are well established, the impact of TFA from ruminants (rTFA) on cardiovascular risk factors has not been as well characterized. We have previously shown in men that a very high dietary intakes of rTFA (>3.5% of energy) leads to unfavourable changes in lipid cardiovascular risk factors that are similar to those seen with iTFA. However, our data also indicated that achievable intakes of rTFA that remain well above the current human consumption (1.5% of energy intake) had neutral effects on plasma lipids and other cardiovascular disease (CVD) risk factors in men. Other studies have also suggested that the LDL and HDL response to very high dietary intakes of rTFA (>5% of energy) in women may be different than in men.

The general objective of the study is to investigate for the first time in a double-blind randomized controlled study the impact of high but yet achievable intake of ruminant trans fatty acids on plasma LDL-Cholesterol and other risk factors for CVD in healthy women.

Detailed Description

Ruminant trans fatty acids (rTFA) will come from an experimental butter formulated from dairy fat obtained after having modified the regimen of lactating cows. All diets will be identical in terms of menus, calories and macronutrient composition with the exception of TFA levels. All foods will be provided to study participants. Based on a 2500 kcal/day regimen, an intake of 4.1g of rTFA will represent 37 kcal/day (1.5% of energy intake) while the intake of 0.7 g of rTFA in the control diet will represent 6 calories (0.3% of energy). The 2 experimental diets will be formulated so that the percentage of daily calories from fat (33%), carbohydrates (52%) and proteins (15%) will meet the dietary recommendations of the American Heart Association and the NCEP for primary prevention of CVD.

Conditions

Cardiovascular Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

High dairy trans fat

a diet rich in ruminant trans fatty acids (4.1 g/2500 kcal)

Group Type: EXPERIMENTAL

isocaloric for week diet

Intervention Type: OTHER

Consumption of the 2 experimental diets

1. a diet rich in ruminant trans fatty acids (4.1 g/2500 kcal);

2. a control diet (minimal dietary ruminant trans fatty acids, 0.7 g/2500 kcal).

Low dairy trans fat diet

a control diet (minimal dietary ruminant trans fatty acids, 0.7 g/2500 kcal)

Group Type: ACTIVE_COMPARATOR

isocaloric for week diet

Intervention Type: OTHER

Consumption of the 2 experimental diets

1. a diet rich in ruminant trans fatty acids (4.1 g/2500 kcal);

2. a control diet (minimal dietary ruminant trans fatty acids, 0.7 g/2500 kcal).

Interventions

isocaloric for week diet

Consumption of the 2 experimental diets

1. a diet rich in ruminant trans fatty acids (4.1 g/2500 kcal);

2. a control diet (minimal dietary ruminant trans fatty acids, 0.7 g/2500 kcal).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Healthy women using or not contraceptive agents or hormone supplementation
• For pre-menopausal women: regular menstrual cycle for the last 3 months (25- 35 days)
• LDL-Cholesterol concentration between 2.5 and 4.0 mmol/L
• Stable body weight (+/- 2 kg) for 6 months before the beginning of the study
• Smoking or not

Exclusion Criteria

• Previous history of cardiovascular disease, type 2 diabetes and monogenic dyslipidemia
• Subjects taking medications for hyperlipidemia or hypertension
• Endocrine disorders
• Body mass index > 35 kg/m2
• Food allergies
• Women with extreme nutritional habits such as vegetarism or alcohol consumption > 2 drinks/day
• Elite athletes

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Institute of Nutraceuticals and Functional Foods

OTHER

Sponsor Role: collaborator

Dairy Farmers of Canada

OTHER

Sponsor Role: collaborator

Dairy Australia

INDUSTRY

Sponsor Role: collaborator

Laval University

OTHER

Sponsor Role: lead

Responsible Party

Benoit Lamarche

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Benoît Lamarche, PhD

Role: PRINCIPAL_INVESTIGATOR

Institute of Nutraceutical and Functional Foods (INAF), Laval University

Patrick Couture, MD, FRCP (C, PhD)

Role: STUDY_DIRECTOR

Faculty of Medicine, Laval University

Locations

Institute of Nutraceutical and Functional Foods (INAF), Laval University

Québec, Quebec, Canada

Countries

Canada

References

Motard-Belanger A, Charest A, Grenier G, Paquin P, Chouinard Y, Lemieux S, Couture P, Lamarche B. Study of the effect of trans fatty acids from ruminants on blood lipids and other risk factors for cardiovascular disease. Am J Clin Nutr. 2008 Mar;87(3):593-9. doi: 10.1093/ajcn/87.3.593.

Reference Type: BACKGROUND

PMID: 18326596 (View on PubMed)

Desroches S, Chouinard PY, Galibois I, Corneau L, Delisle J, Lamarche B, Couture P, Bergeron N. Lack of effect of dietary conjugated linoleic acids naturally incorporated into butter on the lipid profile and body composition of overweight and obese men. Am J Clin Nutr. 2005 Aug;82(2):309-19. doi: 10.1093/ajcn.82.2.309.

Reference Type: BACKGROUND

PMID: 16087973 (View on PubMed)

Mauger JF, Lichtenstein AH, Ausman LM, Jalbert SM, Jauhiainen M, Ehnholm C, Lamarche B. Effect of different forms of dietary hydrogenated fats on LDL particle size. Am J Clin Nutr. 2003 Sep;78(3):370-5. doi: 10.1093/ajcn/78.3.370.

Reference Type: BACKGROUND

PMID: 12936917 (View on PubMed)

Lichtenstein AH, Ausman LM, Jalbert SM, Schaefer EJ. Effects of different forms of dietary hydrogenated fats on serum lipoprotein cholesterol levels. N Engl J Med. 1999 Jun 24;340(25):1933-40. doi: 10.1056/NEJM199906243402501.

Reference Type: BACKGROUND

PMID: 10379016 (View on PubMed)

Chardigny JM, Destaillats F, Malpuech-Brugere C, Moulin J, Bauman DE, Lock AL, Barbano DM, Mensink RP, Bezelgues JB, Chaumont P, Combe N, Cristiani I, Joffre F, German JB, Dionisi F, Boirie Y, Sebedio JL. Do trans fatty acids from industrially produced sources and from natural sources have the same effect on cardiovascular disease risk factors in healthy subjects? Results of the trans Fatty Acids Collaboration (TRANSFACT) study. Am J Clin Nutr. 2008 Mar;87(3):558-66. doi: 10.1093/ajcn/87.3.558.

Reference Type: BACKGROUND

PMID: 18326592 (View on PubMed)

Tholstrup T, Raff M, Basu S, Nonboe P, Sejrsen K, Straarup EM. Effects of butter high in ruminant trans and monounsaturated fatty acids on lipoproteins, incorporation of fatty acids into lipid classes, plasma C-reactive protein, oxidative stress, hemostatic variables, and insulin in healthy young men. Am J Clin Nutr. 2006 Feb;83(2):237-43. doi: 10.1093/ajcn/83.2.237.

Reference Type: BACKGROUND

PMID: 16469980 (View on PubMed)

Oomen CM, Ocke MC, Feskens EJ, van Erp-Baart MA, Kok FJ, Kromhout D. Association between trans fatty acid intake and 10-year risk of coronary heart disease in the Zutphen Elderly Study: a prospective population-based study. Lancet. 2001 Mar 10;357(9258):746-51. doi: 10.1016/s0140-6736(00)04166-0.

Reference Type: BACKGROUND

PMID: 11253967 (View on PubMed)

Mozaffarian D, Katan MB, Ascherio A, Stampfer MJ, Willett WC. Trans fatty acids and cardiovascular disease. N Engl J Med. 2006 Apr 13;354(15):1601-13. doi: 10.1056/NEJMra054035. No abstract available.

Reference Type: BACKGROUND

PMID: 16611951 (View on PubMed)

Willett WC, Stampfer MJ, Manson JE, Colditz GA, Speizer FE, Rosner BA, Sampson LA, Hennekens CH. Intake of trans fatty acids and risk of coronary heart disease among women. Lancet. 1993 Mar 6;341(8845):581-5. doi: 10.1016/0140-6736(93)90350-p.

Reference Type: BACKGROUND

PMID: 8094827 (View on PubMed)

Willett W, Mozaffarian D. Ruminant or industrial sources of trans fatty acids: public health issue or food label skirmish? Am J Clin Nutr. 2008 Mar;87(3):515-6. doi: 10.1093/ajcn/87.3.515. No abstract available.

Reference Type: BACKGROUND

PMID: 18326587 (View on PubMed)

Lacroix E, Charest A, Cyr A, Baril-Gravel L, Lebeuf Y, Paquin P, Chouinard PY, Couture P, Lamarche B. Randomized controlled study of the effect of a butter naturally enriched in trans fatty acids on blood lipids in healthy women. Am J Clin Nutr. 2012 Feb;95(2):318-25. doi: 10.3945/ajcn.111.023408. Epub 2011 Dec 28.

Reference Type: DERIVED

PMID: 22205319 (View on PubMed)

Other Identifiers

INAF-2009-084

Identifier Type: -

Identifier Source: org_study_id