Efficacy Study Regarding the Beneficial Effects of Omega-3 Fatty Acids on Cardiometabolic Health (FOHS)
Primary Purpose
Metabolic Syndrome X
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Fish oil supplement
Sponsored by
About this trial
This is an interventional treatment trial for Metabolic Syndrome X focused on measuring Fish oil, EPA, DHA, fatty acids, genetic variation, gene expression
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
Sites / Locations
- University of Guelph - Human Nutraceutical Research Unit
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Fish oil supplement
Arm Description
Fish oil supplements providing up to 3g per day of EPA and DHA
Outcomes
Primary Outcome Measures
Blood Triglyceride
Blood triglycerides were measured at distinct time points: baseline, after 3 months supplementation, and after a 2 month wash out period.
Secondary Outcome Measures
Blood Glucose
Blood glucose levels measured at distinct time points: baseline, after 3 months supplementation, and after a 2 month wash out period.
Full Information
NCT ID
NCT02042274
First Posted
January 20, 2014
Last Updated
February 17, 2017
Sponsor
University of Guelph
1. Study Identification
Unique Protocol Identification Number
NCT02042274
Brief Title
Efficacy Study Regarding the Beneficial Effects of Omega-3 Fatty Acids on Cardiometabolic Health
Acronym
FOHS
Official Title
Omega-3 Fatty Acids and Genes Interact to Influence Cardiometabolic Health.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Guelph
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome X
Keywords
Fish oil, EPA, DHA, fatty acids, genetic variation, gene expression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fish oil supplement
Arm Type
Experimental
Arm Description
Fish oil supplements providing up to 3g per day of EPA and DHA
Intervention Type
Dietary Supplement
Intervention Name(s)
Fish oil supplement
Other Intervention Name(s)
Jamieson Omega-3 complete supplements, Ocean Nutrition MEG-3 supplements
Intervention Description
Participants are instructed to consume fish oil supplements on a daily basis for a 3-month period.
Primary Outcome Measure Information:
Title
Blood Triglyceride
Description
Blood triglycerides were measured at distinct time points: baseline, after 3 months supplementation, and after a 2 month wash out period.
Time Frame
Baseline, 3 months, 5 months
Secondary Outcome Measure Information:
Title
Blood Glucose
Description
Blood glucose levels measured at distinct time points: baseline, after 3 months supplementation, and after a 2 month wash out period.
Time Frame
Baseline, 3 months, 5 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David M Mutch, PhD
Organizational Affiliation
University of Guelph
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Guelph - Human Nutraceutical Research Unit
City
Guelph
State/Province
Ontario
ZIP/Postal Code
N1G2W1
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24936800
Citation
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.
Results Reference
result
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Efficacy Study Regarding the Beneficial Effects of Omega-3 Fatty Acids on Cardiometabolic Health
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