Independent and Combined Effects of Resistance Exercise Training and β-hydroxy β-methylbutyrate Plus Vitamin D

Not Applicable

• Conditions: Aging; Skeletal Muscle

• 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.

Study Timeline

• Study First Submitted: 2019-02-18
• Study First Submitted QC: 2019-02-19
• Study First Posted: 2019-02-21
• Study Start: 2019-04-01
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-15
• Last Update Posted: 2019-07-17
• Primary Completion: 2020-12
• Study Completion: 2021-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 48

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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