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Completed

NCT Number: NCT02042274

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

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Key information

Conditions

Metabolic Syndrome X Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Guelph - Human Nutraceutical Research Unit

Guelph, Ontario, N1G2W1, Canada

About this study

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:

  • 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).
  • 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).
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fish Oil Supplement

Dietary 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

Primary outcomes

  1. Blood Triglyceride

    Time frame: Baseline, 3 months, 5 months

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

Secondary outcomes

  1. Blood Glucose

    Time frame: Baseline, 3 months, 5 months

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

Sponsors and collaborators

Lead sponsor

University of Guelph

Other

Registry information

Official study title

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

Acronym: FOHS

Important dates

Study start
2012
Primary completion
2013
Study completion
2015
First posted
Jan 22, 2014
Registry last updated
Apr 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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