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

Purpose

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.

Condition	Intervention	Phase
Cardiovascular Disease	Dietary Supplement: n-3 PUFA supplementation	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Genes, Omega-3 Fatty Acids and Cardiovascular Disease Risk Factors

Resource links provided by NLM:

MedlinePlus related topics: Genes and Gene Therapy

Drug Information available for: Omega-3 Fatty Acids

U.S. FDA Resources

Further study details as provided by Laval University:

Primary Outcome Measures:

Change in blood lipids (Total cholesterol, HDL-Cholesterol, Triglycerides) [ Time Frame: Before and after a 6-weeks supplementation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in blood pressure [ Time Frame: Before and after a 6-weeks supplementation ] [ Designated as safety issue: No ]
Change in anthropometric measures (waist and hip girth) [ Time Frame: Before and after a 6-weeks supplementation ] [ Designated as safety issue: No ]
Change in plasma glycemia and insulin levels [ Time Frame: Before and after a 6-weeks supplementation ] [ Designated as safety issue: No ]
Change in gene expression levels [ Time Frame: Before and after a 6-weeks supplementation ] [ Designated as safety issue: No ]


Estimated Enrollment:	200
Study Start Date:	October 2009
Estimated Study Completion Date:	March 2016
Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: capsules omega-3 Omega-3 supplementation (3g EPA+DHA/d)	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.

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


Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01343342

Locations


Canada
Institute of Nutraceutical and Functional Foods (INAF), Laval University
Quebec, Canada, G1V0A6

Sponsors and Collaborators

Laval University

Investigators


Principal Investigator:	Marie-Claude Vohl, Ph.D.	Institute of Nutraceutical and Functional Foods (INAF), Laval University

More Information

No publications provided by Laval University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bouchard-Mercier A, Rudkowska I, Lemieux S, Couture P, Pérusse 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.

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.

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.

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.

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.


Responsible Party:	Marie-Claude Vohl, Professeur, Laval University
ClinicalTrials.gov Identifier:	NCT01343342 History of Changes
Other Study ID Numbers:	FAS
Study First Received:	April 21, 2011
Last Updated:	September 25, 2013
Health Authority:	Canada: Ethics Review Committee Canada: Health Canada

Keywords provided by Laval University:


omega-3 PUFA fatty acids cardiovascular disease gene expression

Additional relevant MeSH terms:


Cardiovascular Diseases

ClinicalTrials.gov processed this record on March 03, 2015

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