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

Omega-3 Fatty Acids and Genes Interact to Influence Cardiometabolic Health.

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome X
• Intervention / Treatment: Dietary supplement: Fish oil supplement

Detailed Description

The typical Western diet is now recognized to have insufficient amounts of omega-3 fatty acids (in particular EPA and DHA). These fatty acids have several known health benefits, including improvements in heart health, metabolic syndrome, and inflammation. These benefits occur because omega-3 fatty acids can regulate a myriad of cellular functions. In order to increase the levels of these omega-3 fatty acids in the body, individuals must either consume more marine products or take an omega-3 rich dietary supplement, such as fish oil. While fish oil supplements are commonly consumed by people, it is now recognized that not everyone responds to these supplements in the same manner. Therefore this study aims to improve our understanding of why people respond differently to the same dietary supplement. The goals of this research will be accomplished using a number of approaches:

1. The investigators will examine how fish oil supplementation leads to an enrichment of EPA and DHA in various cells throughout the body (erythrocytes, adipose tissue, etc).
2. The investigators will determine the dynamic changes in EPA and DHA incorporation into different cell-types during distinct phases of our dietary intervention study (e.g. during supplementation and subsequent wash out periods).
3. The investigators will study how fish oil supplements influence various blood markers of cardiometabolic health (e.g. triglycerides, cholesterol, glucose, C-reactive protein, etc) and whether this is modulated by an individual's genotype.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Guelph, Ontario, Canada, N1G2W1
      • University of Guelph - Human Nutraceutical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fish oil supplement; Fish oil supplements providing up to 3g per day of EPA and DHA	Dietary supplement: Fish oil supplement; Participants are instructed to consume fish oil supplements on a daily basis for a 3-month period.; Other Names: Jamieson Omega-3 complete supplements; Ocean Nutrition MEG-3 supplements

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Glucose	Blood glucose levels measured at distinct time points: baseline, after 3 months supplementation, and after a 2 month wash out period.	Baseline, 3 months, 5 months

Collaborators and Investigators

• Sponsor: University of Guelph
• Investigators: Principal Investigator: David M Mutch, PhD, University of Guelph

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: January 20, 2014
• First Submitted That Met QC Criteria: January 20, 2014
• First Posted (Estimate): January 22, 2014

Study Record Updates

• Last Update Posted (Actual): April 5, 2017
• Last Update Submitted That Met QC Criteria: February 17, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: DHA; Fish oil; gene expression; EPA; fatty acids; genetic variation
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Metabolic Syndrome
• Other Study ID Numbers: Fish Oil and Health Study; 12JL006 (Other Identifier: University of Guelph)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO