Cardiovascular DiseaseFASNCT01343342
Genes, Omega-3 Fatty Acids and Cardiovascular Disease Risk Factors
A study testing n-3 PUFA supplementation in people with Cardiovascular Disease, run by Laval University at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- n-3 PUFA supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2009to Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institute of Nutraceutical and Functional Foods (INAF), Laval University
Québec, G1V0A6
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.
Read the 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.
- Conditions
- Cardiovascular Disease
- Being tested
- n-3 PUFA supplementation
- Keywords
- omega-3, PUFA, fatty acids, cardiovascular disease, gene expression
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
n-3 PUFA supplementationDietary supplement
Also called MEG-3 from Ocean Nutrition Canada,Nova Scotia,Canada.
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)
| Study group | Role | What they receive |
|---|---|---|
| capsules omega-3 | Experimental | Omega-3 supplementation (3g EPA+DHA/d) Receives: Dietary Supplement: n-3 PUFA supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood lipids (Total cholesterol, HDL-Cholesterol, Triglycerides)
Measured: Before and after a 6-weeks supplementation
Secondary outcomes (4)
Change in blood pressure
Measured: Before and after a 6-weeks supplementation
Change in anthropometric measures (waist and hip girth)
Measured: Before and after a 6-weeks supplementation
Change in plasma glycemia and insulin levels
Measured: Before and after a 6-weeks supplementation
Change in gene expression levels
Measured: Before and after a 6-weeks supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2011 (estimated)
- Study startOct 2009
- Primary completionDec 2011
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie-Claude Vohl, Laval University
- Investigators
- Marie-Claude Vohl, Ph.D., Principal investigator, Institute of Nutraceutical and Functional Foods (INAF), Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01343342
- Sponsor's protocol ID
- FAS
- Acronym
- FAS
- Status last verified
- Sep 2026
- First submitted
- 21 Apr 2011
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Picklo M, Vallee Marcotte B, Bukowski M, de Toro-Martin J, Rust BM, Guenard F, Vohl MC. Identification of Phenotypic Lipidomic Signatures in Response to Long Chain n-3 Polyunsaturated Fatty Acid Supplementation in Humans. J Am Heart Assoc. 2021 Feb 2;10(3):e018126. doi: 10.1161/JAHA.120.018126. Epub 2021 Jan 19.
PubMed 33461307Vallee Marcotte B, Guenard F, Lemieux S, Couture P, Rudkowska I, Calder PC, Minihane AM, Vohl MC. Fine mapping of genome-wide association study signals to identify genetic markers of the plasma triglyceride response to an omega-3 fatty acid supplementation. Am J Clin Nutr. 2019 Jan 1;109(1):176-185. doi: 10.1093/ajcn/nqy298.
PubMed 30624603Tremblay BL, Cormier H, Rudkowska I, Lemieux S, Couture P, Vohl MC. Association between polymorphisms in phospholipase A2 genes and the plasma triglyceride response to an n-3 PUFA supplementation: a clinical trial. Lipids Health Dis. 2015 Feb 21;14:12. doi: 10.1186/s12944-015-0009-2.
PubMed 25889305Bouchard-Mercier A, Rudkowska I, Lemieux S, Couture P, Perusse L, Vohl MC. SREBF1 gene variations modulate insulin sensitivity in response to a fish oil supplementation. Lipids Health Dis. 2014 Oct 1;13:152. doi: 10.1186/1476-511X-13-152.
PubMed 25270430Ouellette C, Rudkowska I, Lemieux S, Lamarche B, Couture P, Vohl MC. Gene-diet interactions with polymorphisms of the MGLL gene on plasma low-density lipoprotein cholesterol and size following an omega-3 polyunsaturated fatty acid supplementation: a clinical trial. Lipids Health Dis. 2014 May 24;13:86. doi: 10.1186/1476-511X-13-86.
PubMed 24884512Bouchard-Mercier A, Rudkowska I, Lemieux S, Couture P, Vohl MC. The metabolic signature associated with the Western dietary pattern: a cross-sectional study. Nutr J. 2013 Dec 11;12:158. doi: 10.1186/1475-2891-12-158.
PubMed 24330454Bouchard-Mercier A, Paradis AM, Rudkowska I, Lemieux S, Couture P, Vohl MC. Associations between dietary patterns and gene expression profiles of healthy men and women: a cross-sectional study. Nutr J. 2013 Feb 12;12:24. doi: 10.1186/1475-2891-12-24.
PubMed 23398686Rudkowska I, Paradis AM, Thifault E, Julien P, Tchernof A, Couture P, Lemieux S, Barbier O, Vohl MC. Transcriptomic and metabolomic signatures of an n-3 polyunsaturated fatty acids supplementation in a normolipidemic/normocholesterolemic Caucasian population. J Nutr Biochem. 2013 Jan;24(1):54-61. doi: 10.1016/j.jnutbio.2012.01.016. Epub 2012 Jun 28.
PubMed 22748805
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genes, Omega-3 Fatty Acids and Cardiovascular Disease Risk Factors
- ClinicalTrials.gov ID
- NCT01343342
- Acronym / sponsor ID
- FAS / FAS
- Conditions
- Cardiovascular Disease
- Keywords
- omega-3, PUFA, fatty acids, cardiovascular disease, gene expression
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Mar 2029 (estimated)
- First posted
- 28 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| capsules omega-3 | Experimental | Dietary Supplement: n-3 PUFA supplementationOmega-3 supplementation (3g EPA+DHA/d) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| n-3 PUFA supplementationAlso: MEG-3 from Ocean Nutrition Canada,Nova Scotia,Canada.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) | Dietary supplement | capsules omega-3 |
Primary outcome
Change in blood lipids (Total cholesterol, HDL-Cholesterol, Triglycerides)
Time frame: Before and after a 6-weeks supplementation
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Derived from this study: PubMed 33461307Picklo M, Vallee Marcotte B, Bukowski M, de Toro-Martin J, Rust BM, Guenard F, Vohl MC. Identification of Phenotypic Lipidomic Signatures in Response to Long Chain n-3 Polyunsaturated Fatty Acid Supplementation in Humans. J Am Heart Assoc. 2021 Feb 2;10(3):e018126. doi: 10.1161/JAHA.120.018126. Epub 2021 Jan 19.
- Derived from this study: PubMed 30624603Vallee Marcotte B, Guenard F, Lemieux S, Couture P, Rudkowska I, Calder PC, Minihane AM, Vohl MC. Fine mapping of genome-wide association study signals to identify genetic markers of the plasma triglyceride response to an omega-3 fatty acid supplementation. Am J Clin Nutr. 2019 Jan 1;109(1):176-185. doi: 10.1093/ajcn/nqy298.
- Derived from this study: PubMed 25889305Tremblay BL, Cormier H, Rudkowska I, Lemieux S, Couture P, Vohl MC. Association between polymorphisms in phospholipase A2 genes and the plasma triglyceride response to an n-3 PUFA supplementation: a clinical trial. Lipids Health Dis. 2015 Feb 21;14:12. doi: 10.1186/s12944-015-0009-2.
- Derived from this study: PubMed 25270430Bouchard-Mercier A, Rudkowska I, Lemieux S, Couture P, Perusse L, Vohl MC. SREBF1 gene variations modulate insulin sensitivity in response to a fish oil supplementation. Lipids Health Dis. 2014 Oct 1;13:152. doi: 10.1186/1476-511X-13-152.
- Derived from this study: PubMed 24884512Ouellette C, Rudkowska I, Lemieux S, Lamarche B, Couture P, Vohl MC. Gene-diet interactions with polymorphisms of the MGLL gene on plasma low-density lipoprotein cholesterol and size following an omega-3 polyunsaturated fatty acid supplementation: a clinical trial. Lipids Health Dis. 2014 May 24;13:86. doi: 10.1186/1476-511X-13-86.
- Derived from this study: PubMed 24330454Bouchard-Mercier A, Rudkowska I, Lemieux S, Couture P, Vohl MC. The metabolic signature associated with the Western dietary pattern: a cross-sectional study. Nutr J. 2013 Dec 11;12:158. doi: 10.1186/1475-2891-12-158.
- Derived from this study: PubMed 23398686Bouchard-Mercier A, Paradis AM, Rudkowska I, Lemieux S, Couture P, Vohl MC. Associations between dietary patterns and gene expression profiles of healthy men and women: a cross-sectional study. Nutr J. 2013 Feb 12;12:24. doi: 10.1186/1475-2891-12-24.
- Derived from this study: PubMed 22748805Rudkowska I, Paradis AM, Thifault E, Julien P, Tchernof A, Couture P, Lemieux S, Barbier O, Vohl MC. Transcriptomic and metabolomic signatures of an n-3 polyunsaturated fatty acids supplementation in a normolipidemic/normocholesterolemic Caucasian population. J Nutr Biochem. 2013 Jan;24(1):54-61. doi: 10.1016/j.jnutbio.2012.01.016. Epub 2012 Jun 28.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Claude Vohl, Ph.D. principal investigator
Institute of Nutraceutical and Functional Foods (INAF), Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing n-3 PUFA supplementation in people with Cardiovascular Disease, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in blood lipids (Total cholesterol, HDL-Cholesterol, Triglycerides) (time frame: Before and after a 6-weeks supplementation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01343342, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.