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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 : September 7, 2016
Sponsor:
Information provided by (Responsible Party):
Marie-Claude Vohl, Laval University

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Dietary Supplement: n-3 PUFA supplementation Phase 1

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
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 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Change in blood lipids (Total cholesterol, HDL-Cholesterol, Triglycerides) [ Time Frame: Before and after a 6-weeks supplementation ]

Secondary Outcome Measures :
  1. Change in blood pressure [ Time Frame: Before and after a 6-weeks supplementation ]
  2. Change in anthropometric measures (waist and hip girth) [ Time Frame: Before and after a 6-weeks supplementation ]
  3. Change in plasma glycemia and insulin levels [ Time Frame: Before and after a 6-weeks supplementation ]
  4. 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
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.

Information from the National Library of Medicine

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


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

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

Responsible Party: Marie-Claude Vohl, Professeur, Laval University
ClinicalTrials.gov Identifier: NCT01343342     History of Changes
Other Study ID Numbers: FAS
First Posted: April 28, 2011    Key Record Dates
Last Update Posted: September 7, 2016
Last Verified: September 2016

Keywords provided by Marie-Claude Vohl, Laval University:
omega-3
PUFA
fatty acids
cardiovascular disease
gene expression

Additional relevant MeSH terms:
Cardiovascular Diseases