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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Marie-Claude Vohl, Laval University
ClinicalTrials.gov Identifier:
NCT01343342
First received: April 21, 2011
Last updated: September 25, 2013
Last verified: September 2013

April 21, 2011
September 25, 2013
October 2009
December 2011   (final data collection date for primary outcome measure)
Change in blood lipids (Total cholesterol, HDL-Cholesterol, Triglycerides) [ Time Frame: Before and after a 6-weeks supplementation ] [ Designated as safety issue: No ]
•Change in blood lipids (Total cholesterol, HDL-Cholesterol, Triglycerides) [ Time Frame: before and after a 6-weeks supplementation ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01343342 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Genes, Omega-3 Fatty Acids and Cardiovascular Disease Risk Factors
Genes, Omega-3 Fatty Acids and Cardiovascular Disease Risk Factors

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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Cardiovascular Disease
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.
Experimental: capsules omega-3
Omega-3 supplementation (3g EPA+DHA/d)
Intervention: Dietary Supplement: n-3 PUFA supplementation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
March 2016
December 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01343342
FAS
No
Marie-Claude Vohl, Laval University
Laval University
Not Provided
Principal Investigator: Marie-Claude Vohl, Ph.D. Institute of Nutraceutical and Functional Foods (INAF), Laval University
Laval University
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP