Overview

This trial is active, not recruiting.

Condition metabolic syndrome x
Treatment fish oil supplement
Sponsor University of Guelph
Start date October 2012
End date March 2013
Trial size 80 participants
Trial identifier NCT02042274, 12JL006, Fish Oil and Health Study

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacokinetics/dynamics study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
Fish oil supplements providing up to 3g per day of EPA and DHA
fish oil supplement Jamieson Omega-3 complete supplements
Participants are instructed to consume fish oil supplements on a daily basis for a 3-month period.
(Experimental)
Placebo group will consume an equivalent number of olive oil capsules (relative to fish oil capsules) per day.
fish oil supplement Jamieson Omega-3 complete supplements
Participants are instructed to consume fish oil supplements on a daily basis for a 3-month period.

Primary Outcomes

Measure
Blood lipids
time frame: 5 months

Secondary Outcomes

Measure
Blood glucose and insulin
time frame: 5 months

Eligibility Criteria

Male participants from 18 years up to 25 years old.

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

Additional Information

Official title Omega-3 Fatty Acids and Genes Interact to Influence Cardiometabolic Health.
Principal investigator David M Mutch, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by University of Guelph.