Skip to main content
Clinical Trials/NCT03848741
NCT03848741
Unknown
N/A

Independent and Combined Effects of Resistance Exercise Training and β-hydroxy β-methylbutyrate Plus Vitamin D on Body Composition and Skeletal Muscle Health

University of Illinois at Urbana-Champaign1 site in 1 country48 target enrollmentApril 1, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Aging
Sponsor
University of Illinois at Urbana-Champaign
Enrollment
48
Locations
1
Primary Endpoint
Skeletal Muscle Function - Knee extensor isokinetic performance
Last Updated
6 years ago

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2019
End Date
April 2021
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Adam Konopka

Assistant Professor

University of Illinois at Urbana-Champaign

Eligibility Criteria

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)

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)

Study Sites (1)

Loading locations...

Similar Trials