Recruiting

Resistance Exercise Training & β-Hydroxy β-Methylbutyrate

Sponsor:

University of Illinois at Urbana-Champaign

Code:

NCT03848741

Conditions

Aging

Skeletal Muscle

Eligibility Criteria

Sex: Female

Age: 45 - 60

Healthy Volunteers: Accepted

Interventions

Non-Exercise Control

Resistance Exercise Training

Placebo

HMB+VitD

Study Details

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.

Conditions

Aging

Skeletal Muscle

Study ID

NCT03848741

Start date

Apr 1, 2019

Status verified date

Jul, 2019

Completion date

Apr, 2021

Anticipated

Primary completion date

Dec, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 45 - 60

Healthy Volunteers: Accepted

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

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

placebo comparator: Non-exercise control with placebo

Participants will be asked to maintain their normal physical activity and dietary habits during the 12-week intervention. Physical activity, diet, urine and blood samples will be collected every 4 weeks. Each participant will consume 3 placebo capsules (calcium lactate), twice a day with a meal or snack for a total of 6 capsules per day. Placebo capsules match the size, color, weight, and number of capsules per dose compared to the β-hydroxy β-methylbutyrate (HMB) Plus Vitamin D (VitD) capsules.

experimental: Non-exercise control with HMB+VitD

Participants will be asked to maintain their normal physical activity and dietary habits during the 12-week intervention. Physical activity, diet, urine and blood samples will be collected every 4 weeks. Each participant will consume 3 HMB+VitD capsules, twice a day with a meal or snack for a total of 6 capsules per day. Each capsule contains 500 mg calcium HMB and 333.33 IU Vitamin D for a total of 3.0 g HMB and 2000 IU Vitamin D per day.

active comparator: Resistance exercise training with placebo

Participants will complete 12-weeks (3 days per week) of a whole-body progressive resistance exercise training program. Physical activity, diet, urine and blood samples will be collected every 4 weeks. Each participant will consume 3 placebo capsules (calcium lactate), twice a day with a meal or snack for a total of 6 capsules per day. Participants will be asked to take capsules \~30-60 minutes before resistance exercise. Placebo capsules match the size, color, weight, and number of capsules per dose compared to the HMB + VitD capsules.

experimental: Resistance exercise training with HMB+VitD

Participants will complete 12-weeks (3 days per week) of a whole-body progressive resistance exercise training program. Physical activity, diet, urine and blood samples will be collected every 4 weeks. Each participant will consume 3 HMB+VitD capsules, twice a day with a meal or snack for a total of 6 capsules per day. Participants will be asked to take capsules \~30-60 minutes before resistance exercise. Each capsule contains 500 mg calcium HMB and 333.33 IU Vitamin D for a total of 3.0 g HMB and 2000 IU Vitamin D per day.

Interventions

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.

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

Primary outcome measure

  • Skeletal Muscle Function - Knee extensor isometric performance [ Time Frame: Change from baseline to after the 12 week intervention ]
  • Skeletal Muscle Function - Knee extensor isokinetic performance [ Time Frame: Change from baseline to after the 12 week intervention ]
  • Skeletal Muscle Function - Fatigue [ Time Frame: Change from baseline to after the 12 week intervention ]
  • Skeletal Muscle Cross Sectional Area [ Time Frame: Change from baseline to after the 12 week intervention ]
  • Skeletal Muscle Volume [ Time Frame: Change from baseline to after the 12 week intervention ]
  • Body Composition - Mass [ Time Frame: Change from baseline to after the 12 week intervention ]
  • Body Composition - Percentage [ Time Frame: Change from baseline to after the 12 week intervention ]
  • Skeletal Muscle Mitochondrial Respiration [ Time Frame: Change from baseline to after the 12 week intervention ]
  • Skeletal Muscle Mitochondrial Hydrogen Peroxide Emissions [ Time Frame: Change from baseline to after the 12 week intervention ]
  • Myofiber Size [ Time Frame: Change from baseline to after the 12 week intervention ]

Central Contacts and Locations

Central contacts

Adam Konopka, PhD

1 217 300 5844ark@illinois.edu

Alexander Nichol, MS

1 708 903 1720adnicho2@illinois.edu

Locations

Freer Hall

Recruiting

Urbana, Illinois, United States, 61822

Contacts

Adam Konopka

217-300-5844ark@illinois.edu

More Information

Sponsor

University of Illinois at Urbana-Champaign

Last update posted

Jul 17, 2019

Last verified

Jul, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Illinois at Urbana-Champaign on 2019-07-17.