Independent and Combined Effects of Resistance Exercise Training and β-hydroxy β-methylbutyrate Plus Vitamin D
- Conditions
- AgingSkeletal Muscle
- Interventions
- Behavioral: Non-Exercise ControlBehavioral: Resistance Exercise TrainingDietary Supplement: PlaceboDietary Supplement: HMB+VitD
- Registration Number
- NCT03848741
- Lead Sponsor
- University of Illinois at Urbana-Champaign
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 48
- Women between 45 and 60 years old
- Women with a BMI < 35 kg/m2
- Sedentary (< 30 minutes of structured physical activity 3 times per week)
- Weight stable for 3 months prior (+/- 5kg)
- Body mass index > 35 kg/m2
- Type 1 or Type 2 diabetes
- Uncontrolled hypertension
- Active cancer, cancer in remission, or having received treatment for any form of cancer in the previous 5 years
- Cardiovascular disease (e.g., peripheral artery disease and peripheral vascular disease)
- Uncontrolled thyroid function
- Chronic and/or regular consumption of medication known to influence skeletal muscle metabolism
- Use of Vitamin D (>2000 IU) or β-hydroxy β-methylbutyrate
- Tobacco use
- Any condition that limits exercise training (e.g., chronic obstructive pulmonary disease, neuromuscular disorder, moderate or severe cognitive impairment, Alzheimer's disease, vertigo, dizziness)
- High alcohol consumption defined as more than 8 drinks per week for women
- Unwilling to undergo any study-related procedures
- Pregnancy
- Abnormal liver or kidney enzymes determined in blood chemistry panel
- Bleeding/clotting disorders or blood thinning medications (e.g., warfarin, heparin)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Non-exercise control with placebo Non-Exercise Control 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. Non-exercise control with HMB+VitD Non-Exercise Control 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 Resistance Exercise Training 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. Non-exercise control with placebo 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 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. Non-exercise control with HMB+VitD HMB+VitD 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 HMB+VitD Resistance Exercise Training 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 with placebo 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 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. Resistance exercise training with HMB+VitD 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 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.
- Primary Outcome Measures
Name Time Method Skeletal Muscle Function - Knee extensor isokinetic performance Change from baseline to after the 12 week intervention Knee extensor isokinetic performance will be assessed by a dynamometer.
Skeletal Muscle Function - Fatigue Change from baseline to after the 12 week intervention Knee extensor fatigue will be assessed by a dynamometer.
Skeletal Muscle Function - Knee extensor isometric performance Change from baseline to after the 12 week intervention 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.
Skeletal Muscle Cross Sectional Area Change from baseline to after the 12 week intervention Skeletal muscle cross sectional area will be assessed via magnetic resonance imaging (MRI).
Body Composition - Percentage Change from baseline to after the 12 week intervention Fat and fat free percent will be measured using by a dual x-ray absorptiometry (DEXA) scan.
Skeletal Muscle Mitochondrial Respiration Change from baseline to after the 12 week intervention Mitochondrial respiration will be assessed using high-resolution respirometry in permeabilized muscle fibers.
Body Composition - Mass Change from baseline to after the 12 week intervention Fat and fat free mass will be measured using by a dual x-ray absorptiometry (DEXA) scan.
Skeletal Muscle Volume Change from baseline to after the 12 week intervention Skeletal muscle volume will be assessed via magnetic resonance imaging (MRI).
Myofiber Size Change from baseline to after the 12 week intervention Cross sectional area of muscle fibers will be evaluated with immunohistochemistry.
Skeletal Muscle Mitochondrial Hydrogen Peroxide Emissions Change from baseline to after the 12 week intervention Mitochondrial hydrogen peroxide emissions will be assessed using high-resolution fluorometry in permeabilized muscle fibers.
- Secondary Outcome Measures
Name Time Method Bone Density Change from baseline to after the 12 week intervention Bone mineral density will be evaluated by a dual x-ray absorptiometry (DEXA) scan.
Trial Locations
- Locations (1)
Freer Hall
🇺🇸Urbana, Illinois, United States