Ruminant Trans Fats and the Risk of Cardiovascular Disease in Women

NCT00930137 | Completed

• 1 other identifier: INAF-2009-084
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease

Keywords

Cardiovascular disease; Trans fatty acids; Ruminant; Blood lipids; Lipoproteins; Women

Outcome Measures

Primary Outcomes (1)

• Plasma LDL-Cholesterol concentrations

  At the beginning of the study and the end of the 2 for-week diets

Secondary Outcomes (4)

• 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

• CRP

  At the beginning of the study and the end of the 2 for-week diets

• Blood pressure

  At the beginning of the study and the end of the 2 for-week diets

• Anthropometric measures (waist and hip circumferences)

  At the beginning of the study and the end of the 2 for-week diets

Study Arms (2)

High dairy trans fat

EXPERIMENTAL

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

Other: isocaloric for week diet

Low dairy trans fat diet

ACTIVE COMPARATOR

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

Other: isocaloric for week diet

Interventions

isocaloric for week diet 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).

High dairy trans fat; Low dairy trans fat diet

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Laval University: lead
• Institute of Nutraceuticals and Functional Foods: collaborator
• Dairy Farmers of Canada: collaborator
• Dairy Australia: collaborator

Study Sites (1)

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

Québec, Quebec, G1V 0A6, Canada

Location

Related Publications (11)

• 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.

  PMID: 18326596 BACKGROUND

• 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.

  PMID: 16087973 BACKGROUND

• 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.

  PMID: 12936917 BACKGROUND

• 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.

  PMID: 10379016 BACKGROUND

• 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.

  PMID: 18326592 BACKGROUND

• 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.

  PMID: 16469980 BACKGROUND

• 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.

  PMID: 11253967 BACKGROUND

• 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.

  PMID: 16611951 BACKGROUND

• 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.

  PMID: 8094827 BACKGROUND

• 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.

  PMID: 18326587 BACKGROUND

• 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.

  PMID: 22205319 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Benoît Lamarche, PhD

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

  PRINCIPAL INVESTIGATOR

• Patrick Couture, MD, FRCP (C, PhD)

  Faculty of Medicine, Laval University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 29, 2009
• First Posted: June 30, 2009
• Study Start: September 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: September 1, 2011
• Last Updated: March 5, 2013

Record last verified: 2013-03

Locations

CA (1)