An interventional study of Non-Exercise Control and Resistance Exercise Training in Aging and Skeletal Muscle, sponsored by University of Illinois at Urbana-Champaign. Status unknown at 1 site in United States. Open to female participants aged 45 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-17.
Sponsored by University of Illinois at Urbana-Champaign · Not applicable, Interventional, and Basic science
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.
University of Illinois at Urbana-Champaign is the lead sponsor of 188 studies on the registry; 29 are open to participants now.
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Exclusion Criteria:
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.
Behavioral: Non-Exercise Control · Dietary Supplement: Placebo
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.
Behavioral: Non-Exercise Control · Dietary Supplement: HMB+VitD
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.
Behavioral: Resistance Exercise Training · Dietary Supplement: Placebo
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.
Behavioral: Resistance Exercise Training · Dietary Supplement: HMB+VitD
Participants will not perform structured exercise and will continue with their normal physical activity for 12-weeks.
Participants will complete a 12-week whole-body progressive resistance exercise training program.
Participants will be given placebo capsules to consume for 12-weeks.
Participants will be given HMB+VitD capsules to consume for 12-weeks
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.
Time frame: 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.
Time frame: Change from baseline to after the 12 week intervention
Skeletal Muscle Function - Fatigue
Knee extensor fatigue will be assessed by a dynamometer.
Time frame: 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).
Time frame: Change from baseline to after the 12 week intervention
Skeletal Muscle Volume
Skeletal muscle volume will be assessed via magnetic resonance imaging (MRI).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Change from baseline to after the 12 week intervention
Myofiber Size
Cross sectional area of muscle fibers will be evaluated with immunohistochemistry.
Time frame: Change from baseline to after the 12 week intervention
Bone Density
Bone mineral density will be evaluated by a dual x-ray absorptiometry (DEXA) scan.
Time frame: Change from baseline to after the 12 week intervention
Plan to share: No
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University of Illinois at Urbana-Champaign