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Completed

NCT Number: NCT00930137

Ruminant Trans Fats and the Risk of Cardiovascular Disease in Women

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.

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Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Québec, Quebec, G1V 0A6, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

isocaloric for week diet

Other

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).

Primary outcomes

  1. Plasma LDL-Cholesterol concentrations

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

Secondary outcomes

  1. 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

  2. CRP

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

  3. Blood pressure

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

  4. Anthropometric measures (waist and hip circumferences)

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

Sponsors and collaborators

Lead sponsor

Laval University

Other

Collaborators

  • Dairy Australia
  • Dairy Farmers of Canada
  • Institute of Nutraceuticals and Functional Foods

Registry information

Acronym: TRANSW

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Jun 30, 2009
Registry last updated
Mar 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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