Independent and Combined Effects of Resistance Exercise Training and β-hydroxy β-methylbutyrate Plus Vitamin D on Body Composition and Skeletal Muscle Health
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Skeletal Muscle Function - Knee extensor isokinetic performance
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 45 Years to 60 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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)
Exclusion Criteria
- •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)
Arms & Interventions
Non-exercise control with 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.
Intervention: Non-Exercise Control (Behavioral)
Non-exercise control with 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.
Intervention: Placebo (Dietary Supplement)
Non-exercise control with 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.
Intervention: Non-Exercise Control (Behavioral)
Non-exercise control with 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.
Intervention: HMB+VitD (Dietary Supplement)
Resistance exercise training with 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.
Intervention: Resistance Exercise Training (Behavioral)
Resistance exercise training with 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.
Intervention: Placebo (Dietary Supplement)
Resistance exercise training with 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.
Intervention: Resistance Exercise Training (Behavioral)
Resistance exercise training with 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.
Intervention: HMB+VitD (Dietary Supplement)
Outcomes
Primary Outcomes
Skeletal Muscle Function - Knee extensor isokinetic performance
Time Frame: Change from baseline to after the 12 week intervention
Knee extensor isokinetic performance will be assessed by a dynamometer.
Skeletal Muscle Function - Fatigue
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Change from baseline to after the 12 week intervention
Skeletal muscle volume will be assessed via magnetic resonance imaging (MRI).
Myofiber Size
Time Frame: 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
Time Frame: 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 Outcomes
- Bone Density(Change from baseline to after the 12 week intervention)
Investigators
Adam Konopka
Assistant Professor
University of Illinois at Urbana-Champaign