Ruminant Trans Fats and the Risk of Cardiovascular Disease in Women (TRANSW)

This study has been completed.
Sponsor:
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
First received: June 29, 2009
Last updated: March 4, 2013
Last verified: March 2013
  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: isocaloric for week diet

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:


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 ]

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)
Arms Assigned Interventions
Experimental: High dairy trans fat
a diet rich in ruminant trans fatty acids (4.1 g/2500 kcal)
Other: 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).
Active Comparator: Low dairy trans fat diet
a control diet (minimal dietary ruminant trans fatty acids, 0.7 g/2500 kcal)
Other: 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).

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:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: March 4, 2013
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 April 15, 2014