Ruminant Trans Fats and the Risk of Cardiovascular Disease in Women - Full Text View

Sponsor:	Laval University
Collaborators:	Institute of Nutraceuticals and Functional Foods (INAF) Dairy Farmers of Canada Dairy Australia
Information provided by (Responsible Party):	Benoit Lamarche, Laval University
ClinicalTrials.gov Identifier:	NCT00930137

Purpose

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.

Condition	Intervention
Cardiovascular Disease	Other: Ruminant trans fats

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Ruminant Trans Fats and the Risk of Cardiovascular Disease in Women

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol

U.S. FDA Resources

Further study details as provided by Laval University:

Primary Outcome Measures:

Plasma LDL-Cholesterol concentrations [ Time Frame: At the beginning of the study and the end of the 2 for-week diets ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Blood lipids and apolipoproteins (Total cholesterol, HDL-Cholesterol, Triglycerides, Apo A1, Apo B) [ Time Frame: At the beginning of the study and the end of the 2 for-week diets ] [ Designated as safety issue: No ]
CRP [ Time Frame: At the beginning of the study and the end of the 2 for-week diets ] [ Designated as safety issue: No ]
Blood pressure [ Time Frame: At the beginning of the study and the end of the 2 for-week diets ] [ Designated as safety issue: No ]
Anthropometric measures (waist and hip circumferences) [ Time Frame: At the beginning of the study and the end of the 2 for-week diets ] [ Designated as safety issue: No ]

Estimated Enrollment:	64
Study Start Date:	September 2009
Study Completion Date:	September 2011
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Intervention Details:

Consumption of the 2 experimental diets

a diet rich in ruminant trans fatty acids (4.1 g/2500 kcal);
a control diet (minimal dietary ruminant trans fatty acids, 0.7 g/2500 kcal).

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00930137

Locations

Canada
Institute of Nutraceutical and Functional Foods (INAF), Laval University
Quebec, Canada, G1V 0A6

Sponsors and Collaborators

Laval University

Institute of Nutraceuticals and Functional Foods (INAF)

Dairy Farmers of Canada

Dairy Australia

Investigators

Principal Investigator:	Benoît Lamarche, PhD	Institute of Nutraceutical and Functional Foods (INAF), Laval University
Study Director:	Patrick Couture, MD, FRCP (C, PhD)	Faculty of Medicine, Laval University

More Information

Publications:

Motard-Bélanger 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.

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.

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.

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. Erratum in: N Engl J Med 1999 Sep 9;341(11):856.

Chardigny JM, Destaillats F, Malpuech-Brugère 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, Sébédio 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.

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.

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.

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. Review. No abstract available.

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.

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. No abstract available.

Responsible Party:	Benoit Lamarche, Professor, Laval University
ClinicalTrials.gov Identifier:	NCT00930137 History of Changes
Other Study ID Numbers:	INAF-2009-084
Study First Received:	June 29, 2009
Last Updated:	September 27, 2011
Health Authority:	Canada: Health Canada

Keywords provided by Laval University:

Cardiovascular disease
Trans fatty acids
Ruminant

Blood lipids
Lipoproteins
Women

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 09, 2012