Whole Body Energy Metabolism Clinical Trial
Official title:
Effects of 12 Weeks of Omega 3 Supplementation on Resting Metabolic Rate
| Verified date | December 2015 |
| Source | University of Guelph |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Canada: Ethics Review Committee |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 26 |
| Est. completion date | January 2015 |
| Est. primary completion date | November 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 18 Years to 30 Years |
| Eligibility |
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). |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| Canada | University of Guelph | Guelph | Ontario |
| Lead Sponsor | Collaborator |
|---|---|
| University of Guelph |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in Resting Metabolic Rate From Baseline | Percent change in resting metabolic rate | Baseline, 6 weeks, 12 weeks | No |
| Secondary | Change in Maximum Oxygen Consumption From Baseline | Baseline, 12 weeks | No | |
| Secondary | Change in Whole Body Resting Fat Oxidation From Baseline | Baseline, 6 weeks, 12 weeks | No | |
| Secondary | Change in Whole Body Resting Carbohydrate Oxidation From Baseline | Baseline, 6 weeks, 12 weeks | No | |
| Secondary | Variability of Resting Metabolic Rate Measurement on 2 Consecutive Days | Baseline, 6 weeks, 12 weeks | No | |
| Secondary | Change in Fasted Blood Triglyceride Concentration From Baseline | Baseline, 12 weeks | No |