Whole Body Energy Metabolism
Conditions
Keywords
Omega-3, Resting metabolic rate, Eicosapentaenoic acid, Docosahexaenoic acid
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTOmega-3 Complete
DIETARY_SUPPLEMENTPlacebo Pill
Sponsors
University of Guelph
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to 30 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Resting Metabolic Rate From Baseline | Baseline, 6 weeks, 12 weeks | Percent change in resting metabolic rate |
Secondary
| Measure | 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 |
| 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 |
Countries
Canada
Participant flow
Recruitment details
Recruitment period: May 2014 - Dec 2014 Location: University of Guelph
Participants by arm
| Arm | Count |
|---|---|
| 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 | 13 |
| 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 | 13 |
| Total | 26 |
Baseline characteristics
| Characteristic | Omega-3 Complete | Placebo Pill | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 13 Participants | 26 Participants |
| Age, Continuous | 23 years STANDARD_DEVIATION 3.29 | 22 years STANDARD_DEVIATION 1.61 | 23 years STANDARD_DEVIATION 2.57 |
| Region of Enrollment Canada | 13 participants | 13 participants | 26 participants |
| Resting Metabolic Rate | 2041 kcal/day STANDARD_DEVIATION 187 | 2016 kcal/day STANDARD_DEVIATION 227 | 2029 kcal/day STANDARD_DEVIATION 204 |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 13 Participants | 13 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 13 | 0 / 13 |
| serious Total, serious adverse events | 0 / 13 | 0 / 13 |
Outcome results
Primary
Change in Resting Metabolic Rate From Baseline
Percent change in resting metabolic rate
Time frame: Baseline, 6 weeks, 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Omega-3 Complete | Change in Resting Metabolic Rate From Baseline | Baseline - Week 6 | -0.19 percent change | Standard Deviation 4.7 |
| Omega-3 Complete | Change in Resting Metabolic Rate From Baseline | Baseline - Week 12 | 0.67 percent change | Standard Deviation 8.65 |
| Placebo Pill | Change in Resting Metabolic Rate From Baseline | Baseline - Week 6 | -0.19 percent change | Standard Deviation 4.7 |
| Placebo Pill | Change in Resting Metabolic Rate From Baseline | Baseline - Week 12 | 1.11 percent change | Standard Deviation 6.51 |
Secondary
Change in Fasted Blood Triglyceride Concentration From Baseline
Time frame: Baseline, 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omega-3 Complete | Change in Fasted Blood Triglyceride Concentration From Baseline | -18.07 percent change | Standard Deviation 44.44 |
| Placebo Pill | Change in Fasted Blood Triglyceride Concentration From Baseline | -2.41 percent change | Standard Deviation 60 |
Secondary
Change in Maximum Oxygen Consumption From Baseline
Time frame: Baseline, 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omega-3 Complete | Change in Maximum Oxygen Consumption From Baseline | 3.30 percent change | Standard Deviation 5.54 |
| Placebo Pill | Change in Maximum Oxygen Consumption From Baseline | 2.17 percent change | Standard Deviation 5.52 |
Secondary
Change in Whole Body Resting Carbohydrate Oxidation From Baseline
Time frame: Baseline, 6 weeks, 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Omega-3 Complete | Change in Whole Body Resting Carbohydrate Oxidation From Baseline | Baseline - Week 6 | -3.47 percent change | Standard Deviation 42.05 |
| Omega-3 Complete | Change in Whole Body Resting Carbohydrate Oxidation From Baseline | Baseline - Week 12 | -12.41 percent change | Standard Deviation 39.15 |
| Placebo Pill | Change in Whole Body Resting Carbohydrate Oxidation From Baseline | Baseline - Week 6 | 7.23 percent change | Standard Deviation 32.64 |
| Placebo Pill | Change in Whole Body Resting Carbohydrate Oxidation From Baseline | Baseline - Week 12 | 14.23 percent change | Standard Deviation 42.86 |
Secondary
Change in Whole Body Resting Fat Oxidation From Baseline
Time frame: Baseline, 6 weeks, 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Omega-3 Complete | Change in Whole Body Resting Fat Oxidation From Baseline | Baseline - Week 6 | 0.39 percent change | Standard Deviation 34.53 |
| Omega-3 Complete | Change in Whole Body Resting Fat Oxidation From Baseline | Baseline - Week 12 | 19.52 percent change | Standard Deviation 38.39 |
| Placebo Pill | Change in Whole Body Resting Fat Oxidation From Baseline | Baseline - Week 6 | 2.92 percent change | Standard Deviation 31.37 |
| Placebo Pill | Change in Whole Body Resting Fat Oxidation From Baseline | Baseline - Week 12 | 17.82 percent change | Standard Deviation 48.56 |
Secondary
Variability of Resting Metabolic Rate Measurement on 2 Consecutive Days
Time frame: Baseline, 6 weeks, 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Omega-3 Complete | Variability of Resting Metabolic Rate Measurement on 2 Consecutive Days | Week 0 | 2.70 percent variability | Standard Deviation 2.44 |
| Omega-3 Complete | Variability of Resting Metabolic Rate Measurement on 2 Consecutive Days | Week 6 | 3.98 percent variability | Standard Deviation 3.3 |
| Omega-3 Complete | Variability of Resting Metabolic Rate Measurement on 2 Consecutive Days | Week 12 | 3.22 percent variability | Standard Deviation 2.97 |
| Placebo Pill | Variability of Resting Metabolic Rate Measurement on 2 Consecutive Days | Week 0 | 2.57 percent variability | Standard Deviation 1.32 |
| Placebo Pill | Variability of Resting Metabolic Rate Measurement on 2 Consecutive Days | Week 6 | 2.77 percent variability | Standard Deviation 2.04 |
| Placebo Pill | Variability of Resting Metabolic Rate Measurement on 2 Consecutive Days | Week 12 | 2.18 percent variability | Standard Deviation 1.82 |