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

NCT03848741 | Unknown

• 1 other identifier: 093635
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (10)

• 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

• 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

• Skeletal Muscle Function - Fatigue

  Knee extensor fatigue will be assessed by a dynamometer.

  Change from baseline to after the 12 week intervention

• 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

• Skeletal Muscle Volume

  Skeletal muscle volume will be assessed via magnetic resonance imaging (MRI).

  Change from baseline to after the 12 week intervention

• 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

• 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

• 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

• 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

• Myofiber Size

  Cross sectional area of muscle fibers will be evaluated with immunohistochemistry.

  Change from baseline to after the 12 week intervention

Secondary Outcomes (1)

• Bone Density

  Change from baseline to after the 12 week intervention

Study Arms (4)

Non-exercise control with placebo

PLACEBO COMPARATOR

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.

Behavioral: Non-Exercise Control; Dietary Supplement: Placebo

Non-exercise control with HMB+VitD

EXPERIMENTAL

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.

Behavioral: Non-Exercise Control; Dietary Supplement: HMB+VitD

Resistance exercise training with placebo

ACTIVE COMPARATOR

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.

Behavioral: Resistance Exercise Training; Dietary Supplement: Placebo

Resistance exercise training with HMB+VitD

EXPERIMENTAL

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.

Behavioral: Resistance Exercise Training; Dietary Supplement: HMB+VitD

Interventions

Non-Exercise Control BEHAVIORAL

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

Non-exercise control with HMB+VitD; Non-exercise control with placebo

Resistance Exercise Training BEHAVIORAL

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

Resistance exercise training with HMB+VitD; Resistance exercise training with placebo

Placebo DIETARY_SUPPLEMENT

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

Non-exercise control with placebo; Resistance exercise training with placebo

HMB+VitD DIETARY_SUPPLEMENT

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

Non-exercise control with HMB+VitD; Resistance exercise training with HMB+VitD

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Illinois at Urbana-Champaign: lead
• Metabolic Technologies Inc.: collaborator

Study Sites (1)

Freer Hall

Urbana, Illinois, 61822, United States

RECRUITING

MeSH Terms

Interventions

Resistance Training

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Adam Konopka, PhD

  University of Illinois at Urbana-Champaign

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adam Konopka, PhD

CONTACT

1 217 300 5844; ark@illinois.edu

Alexander Nichol, MS

CONTACT

1 708 903 1720; adnicho2@illinois.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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

Study Record Dates

• First Submitted: February 18, 2019
• First Posted: February 21, 2019
• Study Start: April 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: April 1, 2021
• Last Updated: July 17, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)