Clinical trial NCT03848741: Independent and Combined Effects of Resistance Exercise Training and β-hydroxy β-methylbutyrate Plus Vitamin D
Official title: Independent and Combined Effects of Resistance Exercise Training and β-hydroxy β-methylbutyrate Plus Vitamin D on Body Composition and Skeletal Muscle Health
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aging
Skeletal Muscle
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
Collaborators: name: Metabolic Technologies Inc.
First posted: 2019-02-21
Enrollment: 48
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: BASIC_SCIENCE

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.

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)
* 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)

Primary outcomes:
measure: Skeletal Muscle Function - Knee extensor isometric performance
timeFrame: Change from baseline to after the 12 week intervention
measure: Skeletal Muscle Function - Knee extensor isokinetic performance
timeFrame: Change from baseline to after the 12 week intervention
measure: Skeletal Muscle Function - Fatigue
timeFrame: Change from baseline to after the 12 week intervention
measure: Skeletal Muscle Cross Sectional Area
timeFrame: Change from baseline to after the 12 week intervention
measure: Skeletal Muscle Volume
timeFrame: Change from baseline to after the 12 week intervention
measure: Body Composition - Mass
timeFrame: Change from baseline to after the 12 week intervention
measure: Body Composition - Percentage
timeFrame: Change from baseline to after the 12 week intervention
measure: Skeletal Muscle Mitochondrial Respiration
timeFrame: Change from baseline to after the 12 week intervention
measure: Skeletal Muscle Mitochondrial Hydrogen Peroxide Emissions
timeFrame: Change from baseline to after the 12 week intervention
measure: Myofiber Size
timeFrame: Change from baseline to after the 12 week intervention
Secondary outcomes:
measure: Bone Density
timeFrame: Change from baseline to after the 12 week intervention
Other outcomes:
Locations:
city: Urbana
country: United States
facility: Freer Hall
state: Illinois
Study officials:
affiliation: University of Illinois at Urbana-Champaign
name: Adam Konopka, PhD
role: PRINCIPAL_INVESTIGATOR
References: