Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Text Size

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 6, 2016
Last verified: September 2016
History of Changes
  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: 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:

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 2019
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   (Adult)
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

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 
Study First Received: April 21, 2011
Last Updated: September 6, 2016
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 September 28, 2016