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

NCT01343342 | Active Not Recruiting

• 1 other identifier: FAS
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease

Keywords

omega-3; PUFA; fatty acids; cardiovascular disease; gene expression

Outcome Measures

Primary Outcomes (1)

• Change in blood lipids (Total cholesterol, HDL-Cholesterol, Triglycerides)

  Before and after a 6-weeks supplementation

Secondary Outcomes (4)

• Change in blood pressure

  Before and after a 6-weeks supplementation

• Change in anthropometric measures (waist and hip girth)

  Before and after a 6-weeks supplementation

• Change in plasma glycemia and insulin levels

  Before and after a 6-weeks supplementation

• Change in gene expression levels

  Before and after a 6-weeks supplementation

Study Arms (1)

capsules omega-3

EXPERIMENTAL

Omega-3 supplementation (3g EPA+DHA/d)

Dietary Supplement: n-3 PUFA supplementation

Interventions

n-3 PUFA supplementation DIETARY_SUPPLEMENT

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)

Also known as: MEG-3 from Ocean Nutrition Canada,Nova Scotia,Canada.

capsules omega-3

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laval University: lead

Study Sites (1)

Institute of Nutraceutical and Functional Foods (INAF), Laval University

Québec, G1V0A6, Canada

Location

Related Publications (8)

• 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.

  PMID: 33461307 DERIVED

• Vallee 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.

  PMID: 30624603 DERIVED

• Tremblay 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.

  PMID: 25889305 DERIVED

• Bouchard-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.

  PMID: 25270430 DERIVED

• Ouellette 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.

  PMID: 24884512 DERIVED

• Bouchard-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.

  PMID: 24330454 DERIVED

• Bouchard-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.

  PMID: 23398686 DERIVED

• Rudkowska 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.

  PMID: 22748805 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Marie-Claude Vohl, Ph.D.

  Institute of Nutraceutical and Functional Foods (INAF), Laval University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professeur

Study Record Dates

• First Submitted: April 21, 2011
• First Posted: April 28, 2011
• Study Start: October 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: March 1, 2026
• Last Updated: December 26, 2025

Record last verified: 2025-12

Locations

CA (1)