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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Cardiovascular Disease

Intervention / Treatment
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* Dietary Supplement: n-3 PUFA supplementation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: capsules omega-3<br>Omega-3 supplementation (3g EPA+DHA/d) | Dietary Supplement: n-3 PUFA supplementation<br>* 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)<br>* Other names: MEG-3 from Ocean Nutrition Canada,Nova Scotia,Canada.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in blood lipids (Total cholesterol, HDL-Cholesterol, Triglycerides) |  | Before and after a 6-weeks supplementation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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omega-3, PUFA, fatty acids, cardiovascular disease, gene expression