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| Name | Class |
|---|---|
| Metabolic Technologies Inc. | INDUSTRY |
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During middle-age, humans begin to lose muscle mass and strength. With increasing age the deterioration of muscle health is associated with a decline in quality of life and the loss of independence. β-hydroxy β-methylbutyrate (HMB) plus Vitamin D (VitD) have been proposed to increase skeletal muscle mass, contractile function and improve body composition but has yet to be evaluated in middle-aged women. The overall goal of this study is to determine the effects of HMB +VitD supplementation during 12 weeks of resistance exercise training or a non-exercise control on body composition, skeletal muscle size, and skeletal muscle function in middle-aged women.
To determine if HMB+VitD supplementation is an effective strategy to help prevent the loss of skeletal muscle size, skeletal muscle function and body composition in middle-aged women, forty eight women (45-60 yrs old) will be recruited to complete a 12-week intervention (n=12 per group; 4 groups). Participants will be randomized to complete a non-exercise control period or a resistance exercise training program. In a double-blinded fashion, participants in the non-exercise or resistance exercise groups will be randomized to consume either placebo or HMB+VitD. Before and after each intervention the investigators will evaluate skeletal muscle size, skeletal muscle function, and body composition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-exercise control with placebo | Placebo Comparator | Participants will be asked to maintain their normal physical activity and dietary habits during the 12-week intervention. Physical activity, diet, urine and blood samples will be collected every 4 weeks. Each participant will consume 3 placebo capsules (calcium lactate), twice a day with a meal or snack for a total of 6 capsules per day. Placebo capsules match the size, color, weight, and number of capsules per dose compared to the β-hydroxy β-methylbutyrate (HMB) Plus Vitamin D (VitD) capsules. |
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| Non-exercise control with HMB+VitD | Experimental | Participants will be asked to maintain their normal physical activity and dietary habits during the 12-week intervention. Physical activity, diet, urine and blood samples will be collected every 4 weeks. Each participant will consume 3 HMB+VitD capsules, twice a day with a meal or snack for a total of 6 capsules per day. Each capsule contains 500 mg calcium HMB and 333.33 IU Vitamin D for a total of 3.0 g HMB and 2000 IU Vitamin D per day. |
|
| Resistance exercise training with placebo | Active Comparator | Participants will complete 12-weeks (3 days per week) of a whole-body progressive resistance exercise training program. Physical activity, diet, urine and blood samples will be collected every 4 weeks. Each participant will consume 3 placebo capsules (calcium lactate), twice a day with a meal or snack for a total of 6 capsules per day. Participants will be asked to take capsules ~30-60 minutes before resistance exercise. Placebo capsules match the size, color, weight, and number of capsules per dose compared to the HMB + VitD capsules. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Exercise Control | Behavioral | Participants will not perform structured exercise and will continue with their normal physical activity for 12-weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Skeletal Muscle Function - Knee extensor isometric performance | Knee extensor isometric performance will be assessed by a dynamometer. Muscle strength will also be determined by 1 repetition maximum for leg extension, leg curl and leg press exercises. | Change from baseline to after the 12 week intervention |
| Skeletal Muscle Function - Knee extensor isokinetic performance | Knee extensor isokinetic performance will be assessed by a dynamometer. | Change from baseline to after the 12 week intervention |
| Skeletal Muscle Function - Fatigue | Knee extensor fatigue will be assessed by a dynamometer. | Change from baseline to after the 12 week intervention |
| Skeletal Muscle Cross Sectional Area | Skeletal muscle cross sectional area will be assessed via magnetic resonance imaging (MRI). | Change from baseline to after the 12 week intervention |
| Skeletal Muscle Volume | Skeletal muscle volume will be assessed via magnetic resonance imaging (MRI). | Change from baseline to after the 12 week intervention |
| Body Composition - Mass | Fat and fat free mass will be measured using by a dual x-ray absorptiometry (DEXA) scan. | Change from baseline to after the 12 week intervention |
| Body Composition - Percentage | Fat and fat free percent will be measured using by a dual x-ray absorptiometry (DEXA) scan. |
| Measure | Description | Time Frame |
|---|---|---|
| Bone Density | Bone mineral density will be evaluated by a dual x-ray absorptiometry (DEXA) scan. | Change from baseline to after the 12 week intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adam Konopka, PhD | Contact | 1 217 300 5844 | ark@illinois.edu | |
| Alexander Nichol, MS | Contact | 1 708 903 1720 | adnicho2@illinois.edu |
| Name | Affiliation | Role |
|---|---|---|
| Adam Konopka, PhD | University of Illinois at Urbana-Champaign | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Freer Hall | Recruiting | Urbana | Illinois | 61822 | United States |
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Participants will be randomized to 1 of 4, 12-week interventions. In a double-blinded fashion, participants will be randomized to consume either placebo or HMB + VitD supplementation.
Group 1 will serve as a non-exercise control with placebo; Group 2 will serve as a non-exercise control with β-hydroxy β-methylbutyrate + Vitamin D; Group 3 will complete resistance exercise training with placebo; Group 4 will complete resistance exercise training with β-hydroxy β-methylbutyrate + Vitamin D
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| Resistance exercise training with HMB+VitD | Experimental | Participants will complete 12-weeks (3 days per week) of a whole-body progressive resistance exercise training program. Physical activity, diet, urine and blood samples will be collected every 4 weeks. Each participant will consume 3 HMB+VitD capsules, twice a day with a meal or snack for a total of 6 capsules per day. Participants will be asked to take capsules ~30-60 minutes before resistance exercise. Each capsule contains 500 mg calcium HMB and 333.33 IU Vitamin D for a total of 3.0 g HMB and 2000 IU Vitamin D per day. |
|
| Resistance Exercise Training | Behavioral | Participants will complete a 12-week whole-body progressive resistance exercise training program. |
|
| Placebo | Dietary Supplement | Participants will be given placebo capsules to consume for 12-weeks. |
|
| HMB+VitD | Dietary Supplement | Participants will be given HMB+VitD capsules to consume for 12-weeks |
|
| Change from baseline to after the 12 week intervention |
| Skeletal Muscle Mitochondrial Respiration | Mitochondrial respiration will be assessed using high-resolution respirometry in permeabilized muscle fibers. | Change from baseline to after the 12 week intervention |
| Skeletal Muscle Mitochondrial Hydrogen Peroxide Emissions | Mitochondrial hydrogen peroxide emissions will be assessed using high-resolution fluorometry in permeabilized muscle fibers. | Change from baseline to after the 12 week intervention |
| Myofiber Size | Cross sectional area of muscle fibers will be evaluated with immunohistochemistry. | Change from baseline to after the 12 week intervention |
| ID | Term |
|---|---|
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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