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

December 19, 2025 updated by: Marie-Claude Vohl, Laval University
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Québec, Canada, G1V0A6
        • Institute of Nutraceutical and Functional Foods (INAF), Laval University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laval University

Investigators

  • Principal Investigator: Marie-Claude Vohl, Ph.D., Institute of Nutraceutical and Functional Foods (INAF), Laval University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

December 1, 2011

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

April 21, 2011

First Submitted That Met QC Criteria

April 27, 2011

First Posted (Estimated)

April 28, 2011

Study Record Updates

Last Update Posted (Estimated)

December 26, 2025

Last Update Submitted That Met QC Criteria

December 19, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FAS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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