Genes, Omega-3 Fatty Acids and Cardiovascular Disease Risk Factors (FAS)
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ClinicalTrials.gov Identifier: NCT01343342 |
Recruitment Status :
Active, not recruiting
First Posted : April 28, 2011
Last Update Posted : February 27, 2020
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Condition or disease | Intervention/treatment | Phase |
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Cardiovascular Disease | Dietary Supplement: n-3 PUFA supplementation | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated 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 : | October 2009 |
Actual Primary Completion Date : | December 2011 |
Estimated Study Completion Date : | March 2024 |

Arm | Intervention/treatment |
---|---|
Experimental: capsules omega-3
Omega-3 supplementation (3g EPA+DHA/d)
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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 Name: MEG-3 from Ocean Nutrition Canada,Nova Scotia,Canada. |
- Change in blood lipids (Total cholesterol, HDL-Cholesterol, Triglycerides) [ Time Frame: Before and after a 6-weeks supplementation ]
- Change in blood pressure [ Time Frame: Before and after a 6-weeks supplementation ]
- Change in anthropometric measures (waist and hip girth) [ Time Frame: Before and after a 6-weeks supplementation ]
- Change in plasma glycemia and insulin levels [ Time Frame: Before and after a 6-weeks supplementation ]
- Change in gene expression levels [ Time Frame: Before and after a 6-weeks supplementation ]

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01343342
Canada | |
Institute of Nutraceutical and Functional Foods (INAF), Laval University | |
Quebec, Canada, G1V0A6 |
Principal Investigator: | Marie-Claude Vohl, Ph.D. | Institute of Nutraceutical and Functional Foods (INAF), Laval University |
Responsible Party: | Marie-Claude Vohl, Professeur, Laval University |
ClinicalTrials.gov Identifier: | NCT01343342 |
Other Study ID Numbers: |
FAS |
First Posted: | April 28, 2011 Key Record Dates |
Last Update Posted: | February 27, 2020 |
Last Verified: | February 2020 |
omega-3 PUFA fatty acids cardiovascular disease gene expression |
Cardiovascular Diseases |