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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03848741
Enrollment
48
Registered
2019-02-21
Start date
2019-04-01
Completion date
2021-04-30
Last updated
2019-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging, Skeletal Muscle

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.

Interventions

Participants will not perform structured exercise and will continue with their normal physical activity for 12-weeks.

BEHAVIORALResistance Exercise Training

Participants will complete a 12-week whole-body progressive resistance exercise training program.

DIETARY_SUPPLEMENTPlacebo

Participants will be given placebo capsules to consume for 12-weeks.

DIETARY_SUPPLEMENTHMB+VitD

Participants will be given HMB+VitD capsules to consume for 12-weeks

Sponsors

Metabolic Technologies Inc.
CollaboratorINDUSTRY
University of Illinois at Urbana-Champaign
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Intervention model description

Participants will be randomized to 1 of 4, 12-week interventions. In a double-blinded fashion, participants will be randomized to consume either placebo or HMB + VitD supplementation. Group 1 will serve as a non-exercise control with placebo; Group 2 will serve as a non-exercise control with β-hydroxy β-methylbutyrate + Vitamin D; Group 3 will complete resistance exercise training with placebo; Group 4 will complete resistance exercise training with β-hydroxy β-methylbutyrate + Vitamin D

Eligibility

Sex/Gender
FEMALE
Age
45 Years to 60 Years
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)

Design outcomes

Primary

MeasureTime frameDescription
Myofiber SizeChange from baseline to after the 12 week interventionCross sectional area of muscle fibers will be evaluated with immunohistochemistry.
Skeletal Muscle Function - Knee extensor isometric performanceChange from baseline to after the 12 week interventionKnee 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 Function - Knee extensor isokinetic performanceChange from baseline to after the 12 week interventionKnee extensor isokinetic performance will be assessed by a dynamometer.
Skeletal Muscle Function - FatigueChange from baseline to after the 12 week interventionKnee extensor fatigue will be assessed by a dynamometer.
Skeletal Muscle Cross Sectional AreaChange from baseline to after the 12 week interventionSkeletal muscle cross sectional area will be assessed via magnetic resonance imaging (MRI).
Skeletal Muscle VolumeChange from baseline to after the 12 week interventionSkeletal muscle volume will be assessed via magnetic resonance imaging (MRI).
Body Composition - MassChange from baseline to after the 12 week interventionFat and fat free mass will be measured using by a dual x-ray absorptiometry (DEXA) scan.
Body Composition - PercentageChange from baseline to after the 12 week interventionFat and fat free percent will be measured using by a dual x-ray absorptiometry (DEXA) scan.
Skeletal Muscle Mitochondrial RespirationChange from baseline to after the 12 week interventionMitochondrial respiration will be assessed using high-resolution respirometry in permeabilized muscle fibers.
Skeletal Muscle Mitochondrial Hydrogen Peroxide EmissionsChange from baseline to after the 12 week interventionMitochondrial hydrogen peroxide emissions will be assessed using high-resolution fluorometry in permeabilized muscle fibers.

Secondary

MeasureTime frameDescription
Bone DensityChange from baseline to after the 12 week interventionBone mineral density will be evaluated by a dual x-ray absorptiometry (DEXA) scan.

Countries

United States

Contacts

Primary ContactAdam Konopka, PhD
ark@illinois.edu1 217 300 5844
Backup ContactAlexander Nichol, MS
adnicho2@illinois.edu1 708 903 1720

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026