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

NCT ID: NCT02042274

Last Updated: 2017-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2015-02-28

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.

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.

Conditions

Metabolic Syndrome X

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fish oil supplement

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

Group Type: EXPERIMENTAL

Fish oil supplement

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Fish oil supplement

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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Jamieson Omega-3 complete supplements; Ocean Nutrition MEG-3 supplements

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Guelph

OTHER

Sponsor Role: lead

Responsible Party

David M Mutch

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David M Mutch, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Guelph

Locations

University of Guelph - Human Nutraceutical Research Unit

Guelph, Ontario, Canada

Countries

Canada

References

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.

Reference Type: RESULT

PMID: 24936800 (View on PubMed)

Other Identifiers

12JL006

Identifier Type: OTHER

Identifier Source: secondary_id

Fish Oil and Health Study

Identifier Type: -

Identifier Source: org_study_id