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

Laval University

Status: Completed

Conditions: Cardiovascular Disease

Treatments: Other: isocaloric for week diet

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00930137

INAF-2009-084

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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64 participants in 2 patient groups

High dairy trans fat

Experimental group

Description:

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

Treatment:

Other: isocaloric for week diet

Low dairy trans fat diet

Active Comparator group

Description:

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

Treatment:

Other: isocaloric for week diet