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
1
Location
1
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 DiseaseIntervention/TreatmentPhase
  • 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

ArmIntervention/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

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

    Secondary Outcome Measures

    1. Change in blood pressure [Before and after a 6-weeks supplementation]

    2. Change in anthropometric measures (waist and hip girth) [Before and after a 6-weeks supplementation]

    3. Change in plasma glycemia and insulin levels [Before and after a 6-weeks supplementation]

    4. 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.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Institute of Nutraceutical and Functional Foods (INAF), Laval UniversityQuebecCanadaG1V0A6

    Sponsors and Collaborators

    • Laval University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Marie-Claude Vohl, Professeur, Laval University
    ClinicalTrials.gov Identifier:
    NCT01343342
    Other Study ID Numbers:
    • FAS
    First Posted:
    Apr 28, 2011
    Last Update Posted:
    Jul 7, 2021
    Last Verified:
    Jul 1, 2021
    Keywords provided by Marie-Claude Vohl, Professeur, Laval University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 7, 2021