Sarcopenia, Dynapenia, Inflammation
Conditions
Brief summary
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).
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTOmega-3 Supplementation
DIETARY_SUPPLEMENTPlacebo
Sponsors
Manitoba Medical Service Foundation
University of Manitoba
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. equal to or greater than 65 years of age, 2. male, 3. they will not participate in a structured exercise program any more than 2-times per week.
Exclusion criteria
1. consumption of anti-inflammatory medication (which would confound the results in terms of the effects that the exercise and nutritional intervention is accomplishing), 2. diagnosis with an inflammatory disease (such as inflammatory bowel disease or rheumatoid arthritis) as this is not the participant population we want to evaluate, 3. consumption of any natural health products that have anti-inflammatory components to them (such as omega-3 fatty acids or omega-3 fortified eggs or more than 2 servings per week of fatty fish), 4. current participation in an exercise program ≥ 2 times per week or current participation in a structured resistance training program \> 1 time per week as we want to evaluate an untrained, sedentary population, 5. has a mental or cognitive disability (such as dementia), and 6. has a physical disability that would limit them from participating in a structured resistance training program.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor Necrosis Factor-alpha | 12 weeks | The cytokine tumor necrosis factor-alpha will be used as the primary outcome to assess change in inflammatory status over the 12 week intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lean Tissue Mass | 12 weeks | Dual energy x-ray absorptiometry will be used to assess changes in lean tissue mass. |
| Leg Press Strength | 12 weeks | A one-repetition maximum leg press strength test will be used to assess lower body strength. |
| Timed up and go Test | 12 weeks | Mobility and balance will be assessed using a 3 meter timed up and go test. |
| Interleukin-6 | 12 weeks | Interleukin-6 will be used to assess changes in inflammatory status. |
| Chest Press Strength | 12 week | A one-repetition maximum chest press strength test will be used to assess upper body strength. |
| 6 Minute Walk Test | 12 weeks | A 6 minute walk test will be used to assess the distance walked in 6 minutes of continuous walking. |
| Bone Mineral Content | 12 weeks | Dual energy x-ray absorptiometry will be used to assess changes in bone mass. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 11 |
| 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 | 12 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Omega-3 Supplementation | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 71.4 years STANDARD_DEVIATION 6.2 | 70.9 years STANDARD_DEVIATION 5 | 71.1 years STANDARD_DEVIATION 5.5 |
| Baseline Characteristics | 175.1 Height (cm) STANDARD_DEVIATION 4.7 | 176.7 Height (cm) STANDARD_DEVIATION 5.7 | 175.9 Height (cm) STANDARD_DEVIATION 5.2 |
| Region of Enrollment Canada | 11 participants | 12 participants | 23 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 11 Participants | 12 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 12 |
| other Total, other adverse events | 0 / 11 | 1 / 12 |
| serious Total, serious adverse events | 0 / 11 | 0 / 12 |
Outcome results
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
Time frame: 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Omega-3 Supplementation | Tumor Necrosis Factor-alpha | Baseline | 1.05 pg/mL | Standard Deviation 0.49 |
| Omega-3 Supplementation | Tumor Necrosis Factor-alpha | 12 weeks post | 1.04 pg/mL | Standard Deviation 0.41 |
| Placebo | Tumor Necrosis Factor-alpha | Baseline | 0.93 pg/mL | Standard Deviation 0.54 |
| Placebo | Tumor Necrosis Factor-alpha | 12 weeks post | 1.18 pg/mL | Standard Deviation 0.59 |
Secondary
6 Minute Walk Test
A 6 minute walk test will be used to assess the distance walked in 6 minutes of continuous walking.
Time frame: 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Omega-3 Supplementation | 6 Minute Walk Test | Baseline | 604.8 meters | Standard Deviation 71.1 |
| Omega-3 Supplementation | 6 Minute Walk Test | 12 weeks post | 636.7 meters | Standard Deviation 89.8 |
| Placebo | 6 Minute Walk Test | Baseline | 622.5 meters | Standard Deviation 43.6 |
| Placebo | 6 Minute Walk Test | 12 weeks post | 646.4 meters | Standard Deviation 64.6 |
Secondary
Bone Mineral Content
Dual energy x-ray absorptiometry will be used to assess changes in bone mass.
Time frame: 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Omega-3 Supplementation | Bone Mineral Content | Baseline | 3.18 kilograms | Standard Deviation 0.31 |
| Omega-3 Supplementation | Bone Mineral Content | 12 week post | 3.19 kilograms | Standard Deviation 0.31 |
| Placebo | Bone Mineral Content | Baseline | 3.26 kilograms | Standard Deviation 0.15 |
| Placebo | Bone Mineral Content | 12 week post | 3.26 kilograms | Standard Deviation 0.16 |
Secondary
Chest Press Strength
A one-repetition maximum chest press strength test will be used to assess upper body strength.
Time frame: 12 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Omega-3 Supplementation | Chest Press Strength | Baseline | 51.4 kilograms | Standard Deviation 19.6 |
| Omega-3 Supplementation | Chest Press Strength | 12 weeks post | 67.2 kilograms | Standard Deviation 25.1 |
| Placebo | Chest Press Strength | Baseline | 49.6 kilograms | Standard Deviation 14.3 |
| Placebo | Chest Press Strength | 12 weeks post | 65.0 kilograms | Standard Deviation 13.9 |
Secondary
Interleukin-6
Interleukin-6 will be used to assess changes in inflammatory status.
Time frame: 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Omega-3 Supplementation | Interleukin-6 | 12 weeks post | 2.1 pg/mL | Standard Deviation 1.49 |
| Omega-3 Supplementation | Interleukin-6 | Baseline | 2.01 pg/mL | Standard Deviation 1.49 |
| Placebo | Interleukin-6 | Baseline | 1.84 pg/mL | Standard Deviation 0.93 |
| Placebo | Interleukin-6 | 12 weeks post | 2.19 pg/mL | Standard Deviation 1.21 |
Secondary
Lean Tissue Mass
Dual energy x-ray absorptiometry will be used to assess changes in lean tissue mass.
Time frame: 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Omega-3 Supplementation | Lean Tissue Mass | Baseline | 55.2 kilograms | Standard Deviation 6.3 |
| Omega-3 Supplementation | Lean Tissue Mass | 12 weeks post | 55.7 kilograms | Standard Deviation 5.9 |
| Placebo | Lean Tissue Mass | Baseline | 55.8 kilograms | Standard Deviation 6.1 |
| Placebo | Lean Tissue Mass | 12 weeks post | 56.5 kilograms | Standard Deviation 5.6 |
Secondary
Leg Press Strength
A one-repetition maximum leg press strength test will be used to assess lower body strength.
Time frame: 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Omega-3 Supplementation | Leg Press Strength | Baseline | 114.5 kilograms | Standard Deviation 38.4 |
| Omega-3 Supplementation | Leg Press Strength | 12 weeks post | 158.7 kilograms | Standard Deviation 50 |
| Placebo | Leg Press Strength | Baseline | 105.7 kilograms | Standard Deviation 27.8 |
| Placebo | Leg Press Strength | 12 weeks post | 142.0 kilograms | Standard Deviation 31.2 |
Secondary
Timed up and go Test
Mobility and balance will be assessed using a 3 meter timed up and go test.
Time frame: 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Omega-3 Supplementation | Timed up and go Test | Baseline | 6.35 seconds | Standard Deviation 1.06 |
| Omega-3 Supplementation | Timed up and go Test | 12 weeks post | 5.83 seconds | Standard Deviation 1.11 |
| Placebo | Timed up and go Test | Baseline | 5.91 seconds | Standard Deviation 0.58 |
| Placebo | Timed up and go Test | 12 weeks post | 5.62 seconds | Standard Deviation 0.44 |