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

Aging Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03848741
• Other study ID #: 093635
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: April 2021

Study information

• Verified date: July 2019
• Source: University of Illinois at Urbana-Champaign
• Contact: Adam Konopka, PhD
• Phone: 1 217 300 5844
• Email: ark[@]illinois.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: April 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 60 Years

Eligibility

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 ß-hydroxy ß-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)

Related Conditions & MeSH terms

• Aging
• Skeletal Muscle

Intervention

Behavioral:
• Non-Exercise Control
Participants will not perform structured exercise and will continue with their normal physical activity for 12-weeks.
• Resistance Exercise Training
Participants will complete a 12-week whole-body progressive resistance exercise training program.

Dietary Supplement:
• Placebo
Participants will be given placebo capsules to consume for 12-weeks.
• HMB+VitD
Participants will be given HMB+VitD capsules to consume for 12-weeks

Locations

Country	Name	City	State
United States	Freer Hall	Urbana	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Urbana-Champaign	Metabolic Technologies Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skeletal Muscle Function - Knee extensor isometric performance	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.	Change from baseline to after the 12 week intervention
Primary	Skeletal Muscle Function - Knee extensor isokinetic performance	Knee extensor isokinetic performance will be assessed by a dynamometer.	Change from baseline to after the 12 week intervention
Primary	Skeletal Muscle Function - Fatigue	Knee extensor fatigue will be assessed by a dynamometer.	Change from baseline to after the 12 week intervention
Primary	Skeletal Muscle Cross Sectional Area	Skeletal muscle cross sectional area will be assessed via magnetic resonance imaging (MRI).	Change from baseline to after the 12 week intervention
Primary	Skeletal Muscle Volume	Skeletal muscle volume will be assessed via magnetic resonance imaging (MRI).	Change from baseline to after the 12 week intervention
Primary	Body Composition - Mass	Fat and fat free mass will be measured using by a dual x-ray absorptiometry (DEXA) scan.	Change from baseline to after the 12 week intervention
Primary	Body Composition - Percentage	Fat and fat free percent will be measured using by a dual x-ray absorptiometry (DEXA) scan.	Change from baseline to after the 12 week intervention
Primary	Skeletal Muscle Mitochondrial Respiration	Mitochondrial respiration will be assessed using high-resolution respirometry in permeabilized muscle fibers.	Change from baseline to after the 12 week intervention
Primary	Skeletal Muscle Mitochondrial Hydrogen Peroxide Emissions	Mitochondrial hydrogen peroxide emissions will be assessed using high-resolution fluorometry in permeabilized muscle fibers.	Change from baseline to after the 12 week intervention
Primary	Myofiber Size	Cross sectional area of muscle fibers will be evaluated with immunohistochemistry.	Change from baseline to after the 12 week intervention
Secondary	Bone Density	Bone mineral density will be evaluated by a dual x-ray absorptiometry (DEXA) scan.	Change from baseline to after the 12 week intervention