- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02092649
Effects of 12 Weeks of Omega 3 Supplementation on Resting Metabolic Rate
Fatty acids are the main components of the cell membranes. It has been demonstrated that diet can alter the characteristics and function of many membranes in the body, which has an effect on cardiovascular and metabolic health. Over the last two decades there has been a substantial rise in the research of the effects of Omega 3 polyunsaturated fatty acids on bodily function. There are two fatty acids that are of particular interest to researchers, eicosapentanoic acid (EPA) and docosahexanoic acid (DHA). These fatty acids have unique unsaturated structures, and their incorporation into biological membranes seems to generate important and positive physiological effects. The body is unable to synthesize these fatty acids in high concentrations to elicit significant effects, so they must be obtained through diet in food or via supplementation.
It has been suggested that EPA and DHA supplementation increases resting metabolic rate (RMR) in humans, in part by increasing the use of fat as a fuel during rest. There are a limited number of studies examining the effects of Omega 3 supplementation on RMR. Some have found an increase in RMR while others have found no change. These studies have some limitations, as that they have either used a small sample size, a low omega fatty acid dose and/or short supplementation periods. Due to the variable results, the investigators will improve the reliability of the RMR measurements by making measures on each subject during two consecutive days at each time point that it is measured (0, 6 and 12 weeks).
Therefore, the purpose of this study is to determine the effects of 12 weeks of omega 3 supplementation (3 g/d) on healthy young adults vs. the supplementation of a placebo. The researchers hypothesize that EPA and DHA supplementation will result in an increase in RMR and fat oxidation in some subjects and not in others. The duplicate RMR measures will determine the prevalence and magnitude of the omega 3 supplementation.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Ontario
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Guelph, Ontario, Canada, N1G 2W1
- University of Guelph
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18 - 30 years of age.
- Must currently practice a consistent diet and exercise regimen, and maintain this throughout the duration of the study.
Exclusion Criteria:
- Current or previous supplementation with omega-3's.
- Average fish intake greater than two times per week.
- Taken any medications, have any medical condition, and hospitalization or surgeries.
- Allergy to fish/fish oil, , (rosemary extract, ascorbyl palmitate, or natural tocopherols).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Omega-3 Complete
Oral ingestion of 3000 mg (5 capsules) of Omega-3 Complete (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) per day for 12 weeks.
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Placebo Comparator: Placebo Pill
Oral ingestion of 3 capsules of a placebo olive oil pill (Swanson Health Products, PO Box 2803 - Fargo, ND 58108 USA) per day for 12 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Resting Metabolic Rate From Baseline
Time Frame: Baseline, 6 weeks, 12 weeks
|
Percent change in resting metabolic rate
|
Baseline, 6 weeks, 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Maximum Oxygen Consumption From Baseline
Time Frame: Baseline, 12 weeks
|
Baseline, 12 weeks
|
Change in Whole Body Resting Fat Oxidation From Baseline
Time Frame: Baseline, 6 weeks, 12 weeks
|
Baseline, 6 weeks, 12 weeks
|
Change in Whole Body Resting Carbohydrate Oxidation From Baseline
Time Frame: Baseline, 6 weeks, 12 weeks
|
Baseline, 6 weeks, 12 weeks
|
Variability of Resting Metabolic Rate Measurement on 2 Consecutive Days
Time Frame: Baseline, 6 weeks, 12 weeks
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Baseline, 6 weeks, 12 weeks
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Change in Fasted Blood Triglyceride Concentration From Baseline
Time Frame: Baseline, 12 weeks
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Baseline, 12 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 14JA044
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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