| Primary | Change in Plasma Concentration of Antibodies to Pertussis Antigen (1 Week Post-vaccine) | The change in plasma antibody concentration for response to the pertussis antigen within the tetanus, diphtheria, and pertussis (TDAP) vaccination will be measured between baseline and one week post-vaccination. | | Posted | | Mean | Standard Deviation | units per ml | | change from baseline at 1 week post-vaccine | | | | ID | Title | Description |
|---|
| OG000 | Nutritional Supplement | Subjects in the supplement group will consume Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: B | | OG001 | Placebo | Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00063.1± 39.7
- OG00163.2± 40.7
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | ANCOVA | | >0.05 | | Slope | -0.24275 | | | 2-Sided | | | | | | | | Superiority | | |
|
| Primary | Change in Plasma Concentration of Antibodies to Pertussis Antigen (2 Weeks Post-vaccine) | The change in plasma antibody concentration for response to the pertussis antigen within the tetanus, diphtheria, and pertussis (TDAP) vaccination will be measured between baseline and two weeks post-vaccination. | | Posted | | Mean | Standard Deviation | units per ml | | change from baseline at 2 weeks post-vaccine | | | | ID | Title | Description |
|---|
| OG000 | Nutritional Supplement | Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo | | OG001 | Placebo | Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo |
|
| Primary | Change in Plasma Concentration of C-Reactive Protein | Plasma c-reactive protein will be measured before and after two weeks of treatment with supplement or placebo. | | Posted | | Mean | Standard Deviation | mg/L | | change from baseline at 2 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | Nutritional Supplement | Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation. Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise. | | OG001 | Placebo | Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation. Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise. |
|
| Primary | Change in the Number of Muscle Macrophages Per Myofiber (Pre- to Post-acute Exercise) | The change in the number of muscle macrophages per myofiber will be calculated for muscle collected before and 72 hours after a single bout of resistance exercise. The changes in macrophage numbers before and after two weeks of treatment with supplement or placebo will be compared. | The overall number of participants analyzed was less than the total number of participants due to insufficient specimen. | Posted | | Mean | Standard Deviation | percent change | | change from baseline at 2 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | Nutritional Supplement | Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation. Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise. |
|
| Primary | Change in Muscle Strength After Exercise Training for 12 Weeks | The change in muscle strength after exercise training will be measured as the difference in one-repetition maximum capability for knee extension from before and after completion of the exercise training program. | | Posted | | Mean | Standard Deviation | pounds | | change from baseline at completion of exercise training phase (12 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Nutritional Supplement | Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation. Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise. | | OG001 | Placebo | Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation. Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise. |
|
| Secondary | Change in Plasma Concentration of Antibodies to Tetanus Antigen (1 Week Post-vaccine) | The change in plasma antibody concentration for response to the tetanus antigen within the tetanus, diphtheria, and pertussis (TDAP) vaccination will be measured between baseline and one week post-vaccination. | | Posted | | Mean | Standard Deviation | units per ml | | change from baseline at 1 week post-vaccine | | | | ID | Title | Description |
|---|
| OG000 | Nutritional Supplement | Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo | | OG001 | Placebo | Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo |
|
| Secondary | Change in Plasma Concentration of Antibodies to Tetanus Antigen (2 Weeks Post-vaccine) | The change in plasma antibody concentration for response to the tetanus antigen within the tetanus, diphtheria, and pertussis (TDAP) vaccination will be measured between baseline and two weeks post-vaccination. | | Posted | | Mean | Standard Deviation | units per ml | | change from baseline at 2 weeks post-vaccine | | | | ID | Title | Description |
|---|
| OG000 | Nutritional Supplement | Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo | | OG001 | Placebo | Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo |
|
| Secondary | Change in Plasma Concentration of Antibodies to Diptheria Antigen (1 Week Post-vaccine) | The change in plasma antibody concentration for response to the diptheria antigen within the tetanus, diphtheria, and pertussis (TDAP) vaccination will be measured between baseline and one week post-vaccination. | | Posted | | Mean | Standard Deviation | units per ml | | change from baseline at 1 week post-vaccine | | | | ID | Title | Description |
|---|
| OG000 | Nutritional Supplement | Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo | | OG001 | Placebo | Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo |
|
| Secondary | Change in Plasma Concentration of Antibodies to Diptheria Antigen (2 Weeks Post-vaccine) | The change in plasma antibody concentration for response to the diptheria antigen within the tetanus, diphtheria, and pertussis (TDAP) vaccination will be measured between baseline and two weeks post-vaccination. | | Posted | | Mean | Standard Deviation | units per ml | | change from baseline at 2 weeks post-vaccine | | | | ID | Title | Description |
|---|
| OG000 | Nutritional Supplement | Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo | | OG001 | Placebo | Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo |
|
| Secondary | Number of Muscle Macrophages Per Myofiber (Resting) | The number of muscle macrophages per myofiber will be counted for resting muscle collected before and after two weeks of treatment with supplement or placebo. | The overall number of participants analyzed was less than the total number of participants due to insufficient specimen. | Posted | | Mean | Standard Deviation | percent change | | change from baseline at 2 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | Nutritional Supplement | Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation. Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise. | | OG001 | Placebo |
|
| Secondary | Change in Muscle Size After Exercise Training for 12 Weeks | The change in size of the thigh muscle group after exercise training will be measured as the difference in cross-sectional area based on CT scan before and after completion of the exercise training program. | | Posted | | Mean | Standard Deviation | centimeters squared | | change from baseline at completion of exercise training phase (12 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Nutritional Supplement | Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation. Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. | | OG001 | Placebo | Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation. Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. |
|
| Secondary | Change in Muscle Strength at Week 16 of the Post-Training Period | The change in muscle strength (one-repetition maximum for knee extension) after completion of the exercise training program will be measured during a follow-up period lacking exercise. | The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study. | Posted | | Mean | Standard Deviation | pounds | | difference between baseline and time point one of de-training follow-up period (week 16) | | | | ID | Title | Description |
|---|
| OG000 | Nutritional Supplement | Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation. Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise. | | OG001 | Placebo | Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation. Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise. |
|
| Secondary | Change in Balance After Exercise Training for 12 Weeks | The change in balance ability after exercise training will be measured as the difference in Berg Balance Scale (Min 0, Max 56, Higher is Better) score between before and after completion of the exercise training program. | The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study. | Posted | | Mean | Standard Deviation | score on a scale | | change from baseline at completion of exercise training (12 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Nutritional Supplement | Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation. Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise. |
|
| Secondary | Change in Balance During the Post-Training Period at 26 Weeks of the Post-training Period | The change in balance based on the Berg Balance Scale (Min 0, Max 56, Higher is Better) score will be measured during a follow-up period lacking exercise after completion of the exercise training program. | The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study. | Posted | | Mean | Standard Deviation | score on a scale | | difference between time of training completion and time point two of de-training follow-up period (26 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Nutritional Supplement | Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation. Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise. |
|
| Secondary | Change in Balance at Week 16 of the Post-Training Period | The change in balance based on the Berg Balance Scale (Min 0, Max 56, Higher is Better) score will be measured during a follow-up period lacking exercise after completion of the exercise training program. | The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study. | Posted | | Mean | Standard Deviation | score on a scale | | difference between time of training completion and time point one of de-training follow-up period (week 16) | | | | ID | Title | Description |
|---|
| OG000 | Nutritional Supplement | Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation. Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise. |
|
| Secondary | Change in Walking Ability After Exercise Training for 12 Weeks | The change in walking ability after exercise training will be measured using the six minute walk test, i.e. the distance the participant can walk without shortness of breath in six minutes. | The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study. | Posted | | Mean | Standard Deviation | meters | | change from baseline at completion of exercise training (12 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Nutritional Supplement | Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation. Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise. | |
|
| Secondary | Change in Walking Ability at Week 16 of the Post-Training Period | The change in walking ability based on the six-minute walk test will be measured during a follow-up period lacking exercise after completion of the exercise training program. | The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study. | Posted | | Mean | Standard Deviation | meters | | difference between end of training and time point one of de-training follow-up period (week 16) | | | | ID | Title | Description |
|---|
| OG000 | Nutritional Supplement | Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation. Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise. | |
|
| Secondary | Change in Walking Ability at Week 26 of the Post-Training Period | The change in walking ability based on the six-minute walk test will be measured during a follow-up period lacking exercise after completion of the exercise training program. | The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study. | Posted | | Mean | Standard Deviation | meters | | difference between end of training and time point two of de-training follow-up period (week 26) | | | | ID | Title | Description |
|---|
| OG000 | Nutritional Supplement | Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation. Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise. | |
|
| Secondary | Change in Gait Speed After Exercise Training for 12 Weeks | The change in gait speed ability after exercise training will be measured as the difference in habitual walking speed for 10 meters before and after completion of the exercise training program. | The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study. | Posted | | Mean | Standard Deviation | meters per second | | change from baseline at completion of exercise training (12 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Nutritional Supplement | Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation. Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise. | |
|
| Secondary | Change in Gait Speed at Week 16 of the Post-Training Period | The change in habitual walking speed over 10 meters will be measured as the difference between values at the end of the training program and time points during a follow-up period lacking exercise. | The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study. | Posted | | Mean | Standard Deviation | meters per second | | difference between after training and time point one of de-training follow-up period (week 16) | | | | ID | Title | Description |
|---|
| OG000 | Nutritional Supplement | Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation. Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise. |
|
| Secondary | Change in Gait Speed During at Week 26 of the Post-Training Period | The change in habitual walking speed over 10 meters will be measured as the difference between values at the end of the training program and time points during a follow-up period lacking exercise. | The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study. | Posted | | Mean | Standard Deviation | meters per second | | difference between after training and time point two of de-training follow-up period (week 26) | | | | ID | Title | Description |
|---|
| OG000 | Nutritional Supplement | Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation. Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise. |
|
| Secondary | Change in Muscle Size at Week 26 of the Post-Training Period | The change in size of the thigh muscle group during the post-training period will be measured as the difference in cross-sectional area based on CT scan at the end of the training program and at the end of study participation. | The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study. | Posted | | Mean | Standard Deviation | centimeters squared | | difference between baseline and time point two of de-training follow-up period (week 26) | | | | ID | Title | Description |
|---|
| OG000 | Nutritional Supplement | Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation. Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise. | | OG001 | Placebo | Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation. Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise. |
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| Secondary | Change in Timed Up and Go After Exercise Training for 12 Weeks | The change in time required to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down will be measured as the difference between before and after completion of the exercise training program. | The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study. | Posted | | Mean | Standard Deviation | seconds | | change from baseline at completion of exercise training (12 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Nutritional Supplement | Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation. Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise. |
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| Secondary | Change in Timed Up and Go at Week 16 of the Post-Training Period | The change in time required to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down will be measured as the difference between time points at the end of the training program and during the post-training period. | The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study. | Posted | | Mean | Standard Deviation | seconds | | difference between after training and time point one of de-training follow-up period (week 16) | | | | ID | Title | Description |
|---|
| OG000 | Nutritional Supplement | Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation. Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise. |
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| Secondary | Change in Timed Up and Go at Week 26 of the Post-Training Period | The change in time required to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down will be measured as the difference between time points at the end of the training program and during the post-training period. | The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study. | Posted | | Mean | Standard Deviation | seconds | | difference between after training and time point two of de-training follow-up period (week 26) | | | | ID | Title | Description |
|---|
| OG000 | Nutritional Supplement | Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation. Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise. |
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| Secondary | Percent Change in Resting Muscle Concentration of Interleukin-1 Beta | The muscle concentration of interleukin-1 beta will be measured before and after two weeks of treatment with supplement or placebo. | The overall number of participants analyzed was less than the total number of participants due to insufficient specimen. | Posted | | Mean | Standard Deviation | percent change | | change from baseline at 2 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | Nutritional Supplement | Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation. Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise. | | OG001 | Placebo |
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| Secondary | Change in Muscle Concentration of Interleukin-1 Beta (Pre- to Post-acute Exercise) | The change in the muscle concentration of interleukin-1 beta before and one hour after a single bout of resistance exercise. The changes in macrophage numbers before and after two weeks of treatment with supplement or placebo will be compared. | The overall number of participants analyzed was less than the total number of participants due to insufficient specimen. | Posted | | Mean | Standard Deviation | percent change | | change from baseline at 2 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | Nutritional Supplement | Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation. Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise. |
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| Secondary | Change in Resting Muscle Atrophy Gene MURF Expression | The change in resting muscle atrophy gene MURF expression will be measured before and after two weeks of treatment with supplement or placebo. | The overall number of participants analyzed was less than the total number of participants due to insufficient specimen. | Posted | | Mean | Standard Deviation | percent change | | percent change from baseline at 2 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | Nutritional Supplement | Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation. Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise. | | OG001 | Placebo |
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| Secondary | Change in Resting Muscle Atrophy Gene MURF Expression (Post-acute Exercise) | The change in resting muscle atrophy gene MURF expression will be measured before and 72 hours after a single bout of exercise completed before and after two weeks of treatment with supplement or placebo. | The overall number of participants analyzed was less than the total number of participants due to insufficient specimen. | Posted | | Mean | Standard Deviation | percent change | | change from baseline at 2 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | Nutritional Supplement | Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation. Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise. | |
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| Secondary | Change in Resting Muscle Protein Kinase B | The change in resting muscle Protein Kinase B will be measured before and after two weeks of treatment with supplement or placebo. | The overall number of participants analyzed was less than the total number of participants due to insufficient specimen. | Posted | | Mean | Standard Deviation | percent change | | change from baseline at 2 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | Nutritional Supplement | Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation. Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise. | | OG001 | Placebo |
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| Secondary | Change in Muscle Protein Kinase B (Post-acute Exercise) | The change in muscle Protein Kinase B will be measured before and 72 hours after a single bout of exercise completed before and after two weeks of treatment with supplement or placebo. | The overall number of participants analyzed was less than the total number of participants due to insufficient specimen. | Posted | | Mean | Standard Deviation | percent change | | change from baseline at 2 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | Nutritional Supplement | Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation. Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise. | | OG001 |
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| Secondary | Change in Number of Muscle Satellite Cells After Exercise Training for 12 Weeks | The change in the satellite cell content of muscle will be measured as the difference in the number of satellite cells in muscle before and after completion of the exercise training program. | The overall number of participants analyzed was less than the total number of participants due to insufficient specimen. | Posted | | Mean | Standard Deviation | percent change | | change from baseline at completion of exercise training (12 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Nutritional Supplement | Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation. Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise. | |
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| Secondary | Change in Number of Myonuclei After Exercise Training for 12 Weeks | The change in the myonuclear content of muscle will be measured as the difference in the number of myonuclei in muscle before and after completion of the exercise training program. | The overall number of participants analyzed was less than the total number of participants due to insufficient specimen. | Posted | | Mean | Standard Deviation | percent change | | change from baseline at completion of exercise training (12 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Nutritional Supplement | Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation. Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise. | | OG001 |
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| Secondary | Change in Muscle Fiber Size After Exercise Training for 12 Weeks | The change in the muscle fiber size will be measured as the difference in fiber size before and after completion of the exercise training program. | The overall number of participants analyzed was less than the total number of participants due to insufficient specimen. | Posted | | Mean | Standard Deviation | percent change | | change from baseline at completion of exercise training (12 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Nutritional Supplement | Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation. Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise. | | OG001 |
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| Other Pre-specified | Plasma Concentration of Aspartate Aminotransferase After Product Consumption for 15 Weeks | Plasma aspartate aminotransferase will be measured as a safety indicator of liver function at baseline, after completion of the exercise training program, and at the end of the study. | The overall number of participants analyzed was less than the total number of participants due to a clinical lab error and a participant not completing entire study. | Posted | | Mean | Standard Deviation | Units/L | | at completion of the exercise training program (15 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Nutritional Supplement | Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation. Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise. |
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| Other Pre-specified | Plasma Concentration of Alanine Aminotransferase After Product Consumption for 15 Weeks | Plasma Alanine Aminotransferase will be measured as a safety indicator of liver function at baseline, after completion of the exercise training program, and at the end of the study. | The overall number of participants analyzed was less than the total number of participants due to a clinical lab error and a participant not completing entire study. | Posted | | Mean | Standard Deviation | Units/L | | completion of the exercise training program (15 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Nutritional Supplement | Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation. Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise. |
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| Other Pre-specified | Ratio of Plasma Concentrations of Blood Urea Nitrogen to Creatinine After Product Consumption for 15 Weeks | Plasma blood urea nitrogen and creatinine will be measured as a safety indicator of kidney function at baseline, after completion of the exercise training program, and at the end of the study. | The overall number of participants analyzed was less than the total number of participants due to a clinical lab error and a participant not completing entire study. | Posted | | Mean | Standard Deviation | ratio | | completion of the exercise training program (15 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Nutritional Supplement | Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation. Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise. |
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| Other Pre-specified | Plasma Concentration of Aspartate Aminotransferase After 42 Weeks of Product Consumption | Plasma aspartate aminotransferase will be measured as a safety indicator of liver function at baseline, after completion of the exercise training program, and at the end of the study. | The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study. | Posted | | Mean | Standard Deviation | Units/L | | end of study (42 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Nutritional Supplement | Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation. Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise. | |
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| Other Pre-specified | Plasma Concentration of Alanine Aminotransferase After 42 Weeks of Product Consumption | Plasma Alanine Aminotransferase will be measured as a safety indicator of liver function at baseline, after completion of the exercise training program, and at the end of the study. | The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study. | Posted | | Mean | Standard Deviation | Units/L | | end of study (42 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Nutritional Supplement | Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation. Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise. | | OG001 |
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| Other Pre-specified | Ratio of Plasma Concentrations of Blood Urea Nitrogen to Creatinine After 42 Weeks of Product Consumption | Plasma blood urea nitrogen and creatinine will be measured as a safety indicator of kidney function at baseline, after completion of the exercise training program, and at the end of the study. | The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study. | Posted | | Mean | Standard Deviation | ratio | | end of study (42 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Nutritional Supplement | Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation. Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise. | |
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| Other Pre-specified | Change in Muscle Strength at Week 26 of the Post-Training Period | The change in muscle strength (one-repetition maximum for knee extension) after completion of the exercise training program will be measured during a follow-up period lacking exercise. | The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study. | Posted | | Mean | Standard Deviation | pounds | | difference between baseline and time point two of de-training follow-up period (week 26) | | | | ID | Title | Description |
|---|
| OG000 | Nutritional Supplement | Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation. Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise. | | OG001 | Placebo | Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation. Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise. |
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| Other Pre-specified | Plasma Concentration of Aspartate Aminotransferase | Plasma aspartate aminotransferase will be measured as a safety indicator of liver function at baseline, after completion of the exercise training program, and at the end of the study. | | Posted | | Mean | Standard Deviation | Units/L | | baseline | | | | ID | Title | Description |
|---|
| OG000 | Nutritional Supplement | Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation. Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise. | | OG001 | Placebo | Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation. Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise. |
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| Other Pre-specified | Plasma Concentration of Alanine Aminotransferase | Plasma Alanine Aminotransferase will be measured as a safety indicator of liver function at baseline, after completion of the exercise training program, and at the end of the study. | The overall number of participants analyzed was less than the total number of participants due to clinical lab error. | Posted | | Mean | Standard Deviation | Units/L | | baseline | | | | ID | Title | Description |
|---|
| OG000 | Nutritional Supplement | Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation. Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise. | | OG001 | Placebo |
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| Other Pre-specified | Ratio of Plasma Concentrations of Blood Urea Nitrogen to Creatinine | Plasma blood urea nitrogen and creatinine will be measured as a safety indicator of kidney function at baseline, after completion of the exercise training program, and at the end of the study. | | Posted | | Mean | Standard Deviation | ratio | | baseline | | | | ID | Title | Description |
|---|
| OG000 | Nutritional Supplement | Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation. Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise. | | OG001 | Placebo | Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation. Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise. |
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