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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omega-3 Complete | Experimental | Oral ingestion of 3000 mg (5 capsules) of Omega-3 Complete (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) per day for 12 weeks. |
|
| Placebo Pill | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega-3 Complete | Dietary Supplement |
| ||
| Placebo Pill |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Resting Metabolic Rate From Baseline | Percent change in resting metabolic rate | Baseline, 6 weeks, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Maximum Oxygen Consumption From Baseline | Baseline, 12 weeks | |
| Change in Whole Body Resting Fat Oxidation From Baseline | Baseline, 6 weeks, 12 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lawrence L Spriet, PhD | University of Guelph | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Guelph | Guelph | Ontario | N1G 2W1 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28212390 | Derived | Jannas-Vela S, Roke K, Boville S, Mutch DM, Spriet LL. Lack of effects of fish oil supplementation for 12 weeks on resting metabolic rate and substrate oxidation in healthy young men: A randomized controlled trial. PLoS One. 2017 Feb 17;12(2):e0172576. doi: 10.1371/journal.pone.0172576. eCollection 2017. |
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Recruitment period: May 2014 - Dec 2014 Location: University of Guelph
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Omega-3 Complete |
| FG001 | 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. Placebo Pill |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
We expect to have a normal distribution of participants in both groups.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Omega-3 Complete |
| BG001 | Placebo Pill |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Resting Metabolic Rate From Baseline | Percent change in resting metabolic rate | Posted | Mean | Standard Deviation | percent change | Baseline, 6 weeks, 12 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Omega-3 Complete |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sebastian Jannas-Vela MSc | University of Guelph | (519)-824-4129 | 53907 | sjannas@uoguelph.ca |
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|
| Change in Whole Body Resting Carbohydrate Oxidation From Baseline |
| Baseline, 6 weeks, 12 weeks |
| Variability of Resting Metabolic Rate Measurement on 2 Consecutive Days | Baseline, 6 weeks, 12 weeks |
| Change in Fasted Blood Triglyceride Concentration From Baseline | Baseline, 12 weeks |
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.
Placebo Pill
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Resting Metabolic Rate | Mean | Standard Deviation | kcal/day |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Change in Maximum Oxygen Consumption From Baseline | Posted | Mean | Standard Deviation | percent change | Baseline, 12 weeks |
|
|
|
| Secondary | Change in Whole Body Resting Fat Oxidation From Baseline | Posted | Mean | Standard Deviation | percent change | Baseline, 6 weeks, 12 weeks |
|
|
|
| Secondary | Change in Whole Body Resting Carbohydrate Oxidation From Baseline | Posted | Mean | Standard Deviation | percent change | Baseline, 6 weeks, 12 weeks |
|
|
|
| Secondary | Variability of Resting Metabolic Rate Measurement on 2 Consecutive Days | Posted | Mean | Standard Deviation | percent variability | Baseline, 6 weeks, 12 weeks |
|
|
|
| Secondary | Change in Fasted Blood Triglyceride Concentration From Baseline | Posted | Mean | Standard Deviation | percent change | Baseline, 12 weeks |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | 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. Placebo Pill | 0 | 13 | 0 | 13 |
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| Week 12 |
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