FAS: Genes, Omega-3 Fatty Acids and Cardiovascular Disease Risk Factors

Sponsor

Laval University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01343342

Collaborator

(none)

200

Enrollment

Location

Arm

173

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Disease	Dietary Supplement: n-3 PUFA supplementation	Phase 1

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Genes, Omega-3 Fatty Acids and Cardiovascular Disease Risk Factors

Study Start Date :

Oct 1, 2009

Actual Primary Completion Date :

Dec 1, 2011

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: capsules omega-3 Omega-3 supplementation (3g EPA+DHA/d)	Dietary Supplement: n-3 PUFA supplementation 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) Other Names: MEG-3 from Ocean Nutrition Canada,Nova Scotia,Canada.

Arm

Intervention/Treatment

Experimental: capsules omega-3

Omega-3 supplementation (3g EPA+DHA/d)

Dietary Supplement: n-3 PUFA supplementation

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)

Other Names:

MEG-3 from Ocean Nutrition Canada,Nova Scotia,Canada.

Outcome Measures

Primary Outcome Measures

Change in blood lipids (Total cholesterol, HDL-Cholesterol, Triglycerides) [Before and after a 6-weeks supplementation]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.