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

Cardiovascular Disease Clinical Trial

— FAS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01343342
• Other study ID #: FAS
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2009
• Est. completion date: March 2025

Study information

• Verified date: October 2023
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: March 2025
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

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)

Locations

Country	Name	City	State
Canada	Institute of Nutraceutical and Functional Foods (INAF), Laval University	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Laval University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in blood lipids (Total cholesterol, HDL-Cholesterol, Triglycerides)		Before and after a 6-weeks supplementation
Secondary	Change in blood pressure		Before and after a 6-weeks supplementation
Secondary	Change in anthropometric measures (waist and hip girth)		Before and after a 6-weeks supplementation
Secondary	Change in plasma glycemia and insulin levels		Before and after a 6-weeks supplementation
Secondary	Change in gene expression levels		Before and after a 6-weeks supplementation