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

Metabolic Syndrome X Clinical Trial

— FOHS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02042274
• Other study ID #: Fish Oil and Health Study
• Secondary ID: 12JL006
• Status: Active, not recruiting
• Phase: N/A
• First received: January 20, 2014
• Last updated: January 21, 2014
• Start date: October 2012
• Est. completion date: December 2014

Study information

• Verified date: January 2014
• Source: University of Guelph
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: December 2014
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 25 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metabolic Syndrome X

Intervention

Dietary Supplement:
• Fish oil supplement
Participants are instructed to consume fish oil supplements on a daily basis for a 3-month period.

Locations

Country	Name	City	State
Canada	University of Guelph - Human Nutraceutical Research Unit	Guelph	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Guelph

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Zulyniak MA, Perreault M, Gerling C, Spriet LL, Mutch DM. Fish oil supplementation alters circulating eicosanoid concentrations in young healthy men. Metabolism. 2013 Aug;62(8):1107-13. doi: 10.1016/j.metabol.2013.02.004. Epub 2013 Mar 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Genotyping	A blood sample collected at the beginning of the study will be used to collect DNA in order to examine an individual's genotype.	Baseline	No
Other	Gene expression	RNA will be isolated from peripheral blood mononuclear cells collected from a blood sample taken at baseline, after 3 months supplementation, and after a 2 month washout period.	5 months	No
Primary	Blood lipids	Blood lipids (e.g. triglycerides and cholesterol) and fatty acids measured at distinct time points: baseline, after 3 months supplementation, and after a 2 month wash out period.	5 months	No
Secondary	Blood glucose and insulin	Blood glucose and insulin levels measured at distinct time points: baseline, after 3 months supplementation, and after a 2 month wash out period.	5 months	No