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| Name | Class |
|---|---|
| Manitoba Medical Service Foundation | OTHER |
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The purpose of this project is to evaluate whether omega-3 fatty acid supplementation (combined eicosapentaenoic acid and docosahexaenoic acid [EPA/DHA] supplement) augments the effects of a 12-week resistance training program in older men. Outcome variables include inflammatory biomarkers in the systemic circulation, body composition and performance measures. The specific inflammatory markers in the blood include: C-reactive protein, tumor necrosis factor-α, interleukin-1β, and interleukin-6. Remaining parameters include: body composition (as assessed by dual energy x-ray absorptiometry), muscle strength (as assessed by chest press and leg press one-repetition maximum strength tests), and functional ability (as assessed by timed up and go test as well as the 6-minute walking test).
Summary: Sarcopenia is a prevalent health concern for many older individuals and finding strategies to ameliorate and reduce the loss of skeletal muscle mass and strength is deemed important for maintaining functional ability and independence as individual's age. Currently, resistance training is considered the standard of care for inducing an anabolic stimulus and preserving as well as enhancing muscle mass and strength in aged individuals. One mechanism whereby older adults seem to lose muscle mass with age is via chronic low grade inflammation. Finding complementary strategies to reduce inflammation, while at the same time building skeletal muscle mass and strength, is considered essential for combating the increased prevalence of sarcopenia observed as the population ages. Using nutritional supplementation strategies, such as omega-3 fatty acids, seems to provide an effect in not only reducing inflammation but also acting as an anabolic stimulus for skeletal muscle growth. It is not known whether or not providing omega-3 fatty acids (in the form of EPA/DHA supplementation) along with resistance training will result in a greater increase in skeletal muscle mass and strength than resistance training alone in an older population.
Hypotheses: The primary hypothesis of this research project is that omega-3 fatty acid supplementation and resistance training for 12 weeks will decrease markers of inflammation more so than resistance training and placebo in a cohort of older adults. A secondary hypothesis of the project is that omega-3 fatty acid supplementation and resistance training for 12 weeks will provide for a greater increase in skeletal muscle mass, strength, and functional ability than resistance training and placebo in a cohort of older adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omega-3 Supplementation | Experimental | This groups will supplement their regular diet with 2.97 grams of combined omega-3 fatty acid (EPA/DHA) supplement in soft gel form on a daily basis for 12 weeks. This group will also complete a whole body progressive resistance training program 3 days per week for 12 weeks. |
|
| Placebo | Placebo Comparator | This group will supplement their regular diet with 3.0 grams of a combined omega-3-6-9 supplement in soft gel form on a daily basis for 12 weeks. This group will also complete a whole body progressive resistance training program 3 days per week for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega-3 Supplementation | Dietary Supplement |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Necrosis Factor-alpha | The cytokine tumor necrosis factor-alpha will be used as the primary outcome to assess change in inflammatory status over the 12 week intervention | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Interleukin-6 | Interleukin-6 will be used to assess changes in inflammatory status. | 12 weeks |
| Lean Tissue Mass | Dual energy x-ray absorptiometry will be used to assess changes in lean tissue mass. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen M Cornish, Ph.D. | University of Manitoba | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Applied Research Centre, Faculty of Kinesiology, University of Manitoba | Winnipeg | Manitoba | R3T2N2 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | Omega-3 Supplementation | This groups will supplement their regular diet with 2.97 grams of combined omega-3 fatty acid (EPA/DHA) supplement in soft gel form on a daily basis for 12 weeks. This group will also complete a whole body progressive resistance training program 3 days per week for 12 weeks. Omega-3 Supplementation |
| FG001 | Placebo | This group will supplement their regular diet with 3.0 grams of a combined omega-3-6-9 supplement in soft gel form on a daily basis for 12 weeks. This group will also complete a whole body progressive resistance training program 3 days per week for 12 weeks. Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Older males (>/= 65 years of age)
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| ID | Title | Description |
|---|---|---|
| BG000 | Omega-3 Supplementation | This groups will supplement their regular diet with 2.97 grams of combined omega-3 fatty acid (EPA/DHA) supplement in soft gel form on a daily basis for 12 weeks. This group will also complete a whole body progressive resistance training program 3 days per week for 12 weeks. Omega-3 Supplementation |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Tumor Necrosis Factor-alpha | The cytokine tumor necrosis factor-alpha will be used as the primary outcome to assess change in inflammatory status over the 12 week intervention | Posted | Mean | Standard Deviation | pg/mL | 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 Supplementation | This groups will supplement their regular diet with 2.97 grams of combined omega-3 fatty acid (EPA/DHA) supplement in soft gel form on a daily basis for 12 weeks. This group will also complete a whole body progressive resistance training program 3 days per week for 12 weeks. Omega-3 Supplementation |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Stephen Cornish | University of Manitoba | 204-474-9981 | Stephen.Cornish@umanitoba.ca |
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015118 | Eicosapentaenoic Acid |
| D004281 | Docosahexaenoic Acids |
| D008043 | Linseed Oil |
| D000074262 | Rapeseed Oil |
| C084865 | black currant oil |
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
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| Placebo | Dietary Supplement |
|
|
| 12 weeks |
| Leg Press Strength | A one-repetition maximum leg press strength test will be used to assess lower body strength. | 12 weeks |
| Timed up and go Test | Mobility and balance will be assessed using a 3 meter timed up and go test. | 12 weeks |
| Bone Mineral Content | Dual energy x-ray absorptiometry will be used to assess changes in bone mass. | 12 weeks |
| Chest Press Strength | A one-repetition maximum chest press strength test will be used to assess upper body strength. | 12 week |
| 6 Minute Walk Test | A 6 minute walk test will be used to assess the distance walked in 6 minutes of continuous walking. | 12 weeks |
| Placebo |
This group will supplement their regular diet with 3.0 grams of a combined omega-3-6-9 supplement in soft gel form on a daily basis for 12 weeks. This group will also complete a whole body progressive resistance training program 3 days per week for 12 weeks. Placebo |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Baseline Characteristics | Mean | Standard Deviation | Height (cm) |
|
|
|
| Secondary | Interleukin-6 | Interleukin-6 will be used to assess changes in inflammatory status. | Posted | Mean | Standard Deviation | pg/mL | 12 weeks |
|
|
|
| Secondary | Lean Tissue Mass | Dual energy x-ray absorptiometry will be used to assess changes in lean tissue mass. | Posted | Mean | Standard Deviation | kilograms | 12 weeks |
|
|
|
| Secondary | Leg Press Strength | A one-repetition maximum leg press strength test will be used to assess lower body strength. | Posted | Mean | Standard Deviation | kilograms | 12 weeks |
|
|
|
| Secondary | Timed up and go Test | Mobility and balance will be assessed using a 3 meter timed up and go test. | Posted | Mean | Standard Deviation | seconds | 12 weeks |
|
|
|
| Secondary | Bone Mineral Content | Dual energy x-ray absorptiometry will be used to assess changes in bone mass. | Posted | Mean | Standard Deviation | kilograms | 12 weeks |
|
|
|
| Secondary | Chest Press Strength | A one-repetition maximum chest press strength test will be used to assess upper body strength. | Posted | Mean | Standard Deviation | kilograms | 12 week |
|
|
|
| Secondary | 6 Minute Walk Test | A 6 minute walk test will be used to assess the distance walked in 6 minutes of continuous walking. | Posted | Mean | Standard Deviation | meters | 12 weeks |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Placebo | This group will supplement their regular diet with 3.0 grams of a combined omega-3-6-9 supplement in soft gel form on a daily basis for 12 weeks. This group will also complete a whole body progressive resistance training program 3 days per week for 12 weeks. Placebo | 0 | 12 | 0 | 12 | 1 | 12 |
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| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D010335 | Pathologic Processes |
| D008055 |
| Lipids |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
| D005224 | Fats, Unsaturated |
| D010938 | Plant Oils |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |