Ruminant Trans Fats and the Risk of Cardiovascular Disease in Women

Cardiovascular Disease Clinical Trial

— TRANSW  

Official title:

Ruminant Trans Fats and the Risk of Cardiovascular Disease in Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00930137
• Other study ID #: INAF-2009-084
• Status: Completed
• Phase: N/A
• First received: June 29, 2009
• Last updated: March 4, 2013
• Start date: September 2009
• Est. completion date: September 2011

Study information

• Verified date: March 2013
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: September 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Other:
• isocaloric for week diet
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).

Locations

Country	Name	City	State
Canada	Institute of Nutraceutical and Functional Foods (INAF), Laval University	Quebec

Sponsors (4)

Lead Sponsor	Collaborator
Laval University	Dairy Australia, Dairy Farmers of Canada, Institute of Nutraceuticals and Functional Foods

Country where clinical trial is conducted

Canada, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Oomen CM, Ocké 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma LDL-Cholesterol concentrations		At the beginning of the study and the end of the 2 for-week diets	No
Secondary	Blood lipids and apolipoproteins (Total cholesterol, HDL-Cholesterol, Triglycerides, Apo A1, Apo B)		At the beginning of the study and the end of the 2 for-week diets	No
Secondary	CRP		At the beginning of the study and the end of the 2 for-week diets	No
Secondary	Blood pressure		At the beginning of the study and the end of the 2 for-week diets	No
Secondary	Anthropometric measures (waist and hip circumferences)		At the beginning of the study and the end of the 2 for-week diets	No