Clinical trial NCT01343342: Genes, Omega-3 Fatty Acids and Cardiovascular Disease Risk Factors
Official title: Genes, Omega-3 Fatty Acids and Cardiovascular Disease Risk Factors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cardiovascular Disease
Keywords: omega-3
PUFA
fatty acids
cardiovascular disease
gene expression
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2011-04-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in blood lipids (Total cholesterol, HDL-Cholesterol, Triglycerides)
timeFrame: Before and after a 6-weeks supplementation
Secondary outcomes:
measure: Change in blood pressure
timeFrame: Before and after a 6-weeks supplementation
measure: Change in anthropometric measures (waist and hip girth)
timeFrame: Before and after a 6-weeks supplementation
measure: Change in plasma glycemia and insulin levels
timeFrame: Before and after a 6-weeks supplementation
measure: Change in gene expression levels
timeFrame: Before and after a 6-weeks supplementation
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: Institute of Nutraceutical and Functional Foods (INAF), Laval University
Study officials:
affiliation: Institute of Nutraceutical and Functional Foods (INAF), Laval University
name: Marie-Claude Vohl, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.