CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 64 enrolled
Drug / intervention
isocaloric for week dietother
Likely dose
Not stated in record
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Search/NCT00930137
NCT00930137N/ACompleted

Ruminant Trans Fats and the Risk of Cardiovascular Disease in Women

Laval University·interventional·Posted Jun 30, 2009·Updated Mar 5, 2013

In Brief

A clinical study evaluating isocaloric for week diet for Cardiovascular Disease. Completed, enrolled 64 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 30, 2009
Enrollment StartSep 1, 2009
Primary CompletionDec 1, 2010
Study CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 17.0 years ago

Interventions

isocaloric for week dietother

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).