Efficacy Study Regarding the Beneficial Effects of Omega-3 Fatty Acids on Cardiometabolic Health

NCT02042274 | Completed Results DMC

• 2 other identifiers: Fish Oil and Health Study12JL006
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Fish oil supplements (which are rich in omega-3 fatty acids) have been shown to provide cardiometabolic benefits to individuals of all ages. Specifically, the daily consumption of fish oil supplements has been reported to reduce blood triglyceride levels, and influence glucose homeostasis and whole-body inflammation. However, recent evidence highlights important gaps in our understanding with respect to the impact of fish oil supplements on health; specifically, not everyone responds to these supplements in the same manner. The goal of this research is to explore how an individual's genetic make-up may modify their response to fish oil supplements.

Conditions

Metabolic Syndrome X

Keywords

Fish oil; EPA; DHA; fatty acids; genetic variation; gene expression

Outcome Measures

Primary Outcomes (1)

• Blood Triglyceride

  Blood triglycerides were measured at distinct time points: baseline, after 3 months supplementation, and after a 2 month wash out period.

  Baseline, 3 months, 5 months

Secondary Outcomes (1)

• Blood Glucose

  Baseline, 3 months, 5 months

Study Arms (1)

Fish oil supplement

EXPERIMENTAL

Fish oil supplements providing up to 3g per day of EPA and DHA

Dietary Supplement: Fish oil supplement

Interventions

Fish oil supplement DIETARY_SUPPLEMENT

Participants are instructed to consume fish oil supplements on a daily basis for a 3-month period.

Also known as: Jamieson Omega-3 complete supplements, Ocean Nutrition MEG-3 supplements

Fish oil supplement

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• between 18-25 years old
• male
• good general health

You may not qualify if:

• currently taking a fish oil supplement
• currently taking an omega-3 supplement
• currently consuming a diet high in omega-3 (high in ALA, EPA, or DHA)
• not able to maintain a consistent lifestyle routine throughout the study duration
• have an allergy which would prevent them from taking a fish oil pill
• schedule conflict with study visits
• overweight or obese

Sponsors & Collaborators

• University of Guelph: lead

Study Sites (1)

University of Guelph - Human Nutraceutical Research Unit

Guelph, Ontario, N1G2W1, Canada

Location

Related Publications (1)

• Roke K, Mutch DM. The role of FADS1/2 polymorphisms on cardiometabolic markers and fatty acid profiles in young adults consuming fish oil supplements. Nutrients. 2014 Jun 16;6(6):2290-304. doi: 10.3390/nu6062290.

  PMID: 24936800 RESULT

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Dr. David Mutch, Associate Professor
• Organization: University of Guelph

dmutch@uoguelph.ca

519-824-4120

Study Officials

• David M Mutch, PhD

  University of Guelph

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 20, 2014
• First Posted: January 22, 2014
• Study Start: October 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: February 1, 2015
• Last Updated: April 5, 2017
• Results First Posted: April 5, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)