Overview

This trial is active, not recruiting.

Condition cardiovascular disease
Treatment n-3 pufa supplementation
Phase phase 1
Sponsor Laval University
Start date October 2009
End date December 2011
Trial size 200 participants
Trial identifier NCT01343342, FAS

Summary

The main purpose of this study is to examine whether n-3 PUFA-induced changes in metabolic risk factors are influenced by genetic variations within genes acting as fatty acids sensors.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Omega-3 supplementation (3g EPA+DHA/d)
n-3 pufa supplementation MEG-3 from Ocean Nutrition Canada,Nova Scotia,Canada.
3g per day of n-3 PUFA supplementation (1.9g EPA, 1.1g DHA). 5 capsules per day (1g fish oil each, 5g of fish oil/day)

Primary Outcomes

Measure
Change in blood lipids (Total cholesterol, HDL-Cholesterol, Triglycerides)
time frame: Before and after a 6-weeks supplementation

Secondary Outcomes

Measure
Change in blood pressure
time frame: Before and after a 6-weeks supplementation
Change in anthropometric measures (waist and hip girth)
time frame: Before and after a 6-weeks supplementation
Change in plasma glycemia and insulin levels
time frame: Before and after a 6-weeks supplementation
Change in gene expression levels
time frame: Before and after a 6-weeks supplementation

Eligibility Criteria

Male or female participants from 18 years up to 50 years old.

Inclusion Criteria: - healthy men and women aged between 18 to 50 years; - having a BMI between 25 and 40kg/m2; - plasma triglycerides levels <4.0 mmol/L; - non-smokers; - free of any thyroid or metabolic disorders requiring treatment such as diabetes, hypertension, severe dyslipidemia, and coronary heart disease. Exclusion Criteria: - subjects taking medication for hyperlipidemia, hypertension, diabetes or taking anticoagulant or n-3 PUFA supplementation; - having a taste aversion for fish, fish allergy or regular alcohol drinker; - body mass index > 40kg/m2; - pregnant or nursing women.

Additional Information

Official title Genes, Omega-3 Fatty Acids and Cardiovascular Disease Risk Factors
Principal investigator Marie-Claude Vohl, Ph.D.
Description The main purpose of this study is to examine whether n-3 PUFA-induced changes in metabolic risk factors are influenced by genetic variations within genes acting as fatty acids sensors. To do so, the metabolic risk factor response to an n-e PUFA supplementation will be compared in carriers and non-carriers of polymorphism within genes acting as fatty acids sensors.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Laval University.