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OpenTrials
Active, Not Recruiting

NCT Number: NCT01343342

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Nutraceutical and Functional Foods (INAF), Laval University

Québec, G1V0A6, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

n-3 PUFA supplementation

Dietary Supplement

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.

Primary outcomes

  1. Change in blood lipids (Total cholesterol, HDL-Cholesterol, Triglycerides)

    Time frame: Before and after a 6-weeks supplementation

Secondary outcomes

  1. Change in blood pressure

    Time frame: Before and after a 6-weeks supplementation

  2. Change in anthropometric measures (waist and hip girth)

    Time frame: Before and after a 6-weeks supplementation

  3. Change in plasma glycemia and insulin levels

    Time frame: Before and after a 6-weeks supplementation

  4. Change in gene expression levels

    Time frame: Before and after a 6-weeks supplementation

Sponsors and collaborators

Lead sponsor

Laval University

Other

Registry information

Acronym: FAS

Important dates

Study start
2009
Primary completion
2011
Study completion
2026
First posted
Apr 28, 2011
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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