RCT of Combination Effect of Vibration Treatment and HMB Supplementation on Myosteatosis and NMJ Degeneration

NCT05525039 | Recruiting

• 1 other identifier: CREC 2022.233-T
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

Brief Summary

The investigators' pre-clinical study confirms the positive effects of combined treatment (VT + HMB) on reducing fat-to-lean tissue ratio, intramuscular fat infiltration and increasing muscle strength in sarcopenia animal model. The results showed that fat mass could be decreased by \~32%, while histology Oil Red O staining indicated a decrease of fat by almost 60%; in contrast, lean muscle mass increased by \~14%. On muscle strength, combined treatment increased twitch force, tetanic force and grip strength by \~30-66%. These in vivo results are very encouraging and the investigators should explore its potential in clinical translation. As VT and HMB supplement have been commercially available and their compliance rates are satisfactory, they can be translated to clinical application easily. The investigators' next step is to confirm its clinical efficacy, so that sarcopenia becomes a new indication of VT and HMB. The hypothesis is that combined treatment of VT and HMB can retard the progression of sarcopenia in human, in terms of muscle mass, muscle strength and performance.

Conditions

Sarcopenia; Connective Tissue Diseases in Old Age; Musculoskeletal Abnormalities

Keywords

Sarcopenia; Vibration; Hydroxymethylbutyrate

Outcome Measures

Primary Outcomes (2)

• Muscle strength-handgrip

  Handgrip strength will be measured by a dynamometer on each hand of the subject.

  6 months

• Muscle performance-gait speed

  Gait speed will be assessed by a 6-meter-walk test.

  6 months

Secondary Outcomes (5)

• Dual energy x-ray absortiometry (DXA)

  6 months

• Biodex Balance System-LOS

  6 months

• Biodex Balance System-OSI

  6 months

• Time-up-and-go test (TUG)

  6 months

• 36-item Short-Form Health Survey (SF-36)

  6 months

Study Arms (4)

Control Group

PLACEBO COMPARATOR

Subjects assigned to Contro Group will not receive VT or HMB. They will receive daily protein supplement for 6 months.

Dietary Supplement: Protein supplement

HMB only Group

ACTIVE COMPARATOR

Subjects assigned to HMB only Group will receive HMB supplement at 3g/day and daily protein supplement for 6 months.

Dietary Supplement: β-hydroxy β-methylbutyrate (HMB) supplement; Dietary Supplement: Protein supplement

VT only Group

ACTIVE COMPARATOR

Subjects assigned to VT only Group will receive VT (0.3g, 35Hz, at least 3 times/week) and daily protein supplement for 6 months

Device: Low-magnitude High-frequency Vibration; Dietary Supplement: Protein supplement

HMB + VT Group

EXPERIMENTAL

Subjects assigned to HMB + VT Group will receive HMB supplement at 3g/day, VT at least 3 times/week and daily protein supplement for 6 months.

Device: Low-magnitude High-frequency Vibration; Dietary Supplement: β-hydroxy β-methylbutyrate (HMB) supplement; Dietary Supplement: Protein supplement

Interventions

Low-magnitude High-frequency Vibration DEVICE

0.3g, 35Hz, 20mins/day, at least 3 times/week

Also known as: Vibration Treatment

HMB + VT Group; VT only Group

β-hydroxy β-methylbutyrate (HMB) supplement DIETARY_SUPPLEMENT

Oral nutritional HMB supplement at 3g/day

HMB + VT Group; HMB only Group

Protein supplement DIETARY_SUPPLEMENT

Daily protein supplement intake

Control Group; HMB + VT Group; HMB only Group; VT only Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects aged 60 years or above
• Subjects failed in AWGS algorithm
• skeletal muscle mass by BIA (male at \<7.0 kg/m\^2, female at \<5.7 kg/m\^2), and
• handgrip strength (male at \<28 kg, female at \<18kg), and/or
• gait speed test (\>1m/s)

You may not qualify if:

• Subjects with pathological bone diseases
• Subjects with chronic inflammatory condition (e.g. rheumatoid arthritis)
• Subjects with neurological problems
• Subjects receiving regular exercise
• Subjecs who are chair-/bed- bound
• Subjects with malignancy
• Subjects with cardiovascular concern such as with pace-maker in-situ
• Subjects with acute fractures or severe osteoarthritis

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Abbott: collaborator

Study Sites (3)

Evangelical Luthera Church Social Service - Hong Kong

Hong Kong, Hong Kong

ACTIVE NOT RECRUITING

The Chinese University of Hong Kong Jockey Club Centre for Osteoporosis Care and Control

Hong Kong, Hong Kong

RECRUITING

The Chinese University of Hong Kong, Department of Orthopaedics and Traumatology, 1/F Li Ka Shing Outpatient Clinic (North), PWH

Hong Kong, Hong Kong

RECRUITING

Related Publications (7)

• Leung KS, Li CY, Tse YK, Choy TK, Leung PC, Hung VW, Chan SY, Leung AH, Cheung WH. Effects of 18-month low-magnitude high-frequency vibration on fall rate and fracture risks in 710 community elderly--a cluster-randomized controlled trial. Osteoporos Int. 2014 Jun;25(6):1785-95. doi: 10.1007/s00198-014-2693-6. Epub 2014 Mar 28.

  PMID: 24676848 BACKGROUND

• Wang J, Cui C, Chim YN, Yao H, Shi L, Xu J, Wang J, Wong RMY, Leung KS, Chow SK, Cheung WH. Vibration and beta-hydroxy-beta-methylbutyrate treatment suppresses intramuscular fat infiltration and adipogenic differentiation in sarcopenic mice. J Cachexia Sarcopenia Muscle. 2020 Apr;11(2):564-577. doi: 10.1002/jcsm.12535. Epub 2020 Jan 28.

  PMID: 31994349 BACKGROUND

• Deutz NE, Pereira SL, Hays NP, Oliver JS, Edens NK, Evans CM, Wolfe RR. Effect of beta-hydroxy-beta-methylbutyrate (HMB) on lean body mass during 10 days of bed rest in older adults. Clin Nutr. 2013 Oct;32(5):704-12. doi: 10.1016/j.clnu.2013.02.011. Epub 2013 Mar 4.

  PMID: 23514626 BACKGROUND

• Cheung WH, Mok HW, Qin L, Sze PC, Lee KM, Leung KS. High-frequency whole-body vibration improves balancing ability in elderly women. Arch Phys Med Rehabil. 2007 Jul;88(7):852-7. doi: 10.1016/j.apmr.2007.03.028.

  PMID: 17601464 BACKGROUND

• Zhu LY, Chan R, Kwok T, Cheng KC, Ha A, Woo J. Effects of exercise and nutrition supplementation in community-dwelling older Chinese people with sarcopenia: a randomized controlled trial. Age Ageing. 2019 Mar 1;48(2):220-228. doi: 10.1093/ageing/afy179.

  PMID: 30462162 BACKGROUND

• Chen LK, Liu LK, Woo J, Assantachai P, Auyeung TW, Bahyah KS, Chou MY, Chen LY, Hsu PS, Krairit O, Lee JS, Lee WJ, Lee Y, Liang CK, Limpawattana P, Lin CS, Peng LN, Satake S, Suzuki T, Won CW, Wu CH, Wu SN, Zhang T, Zeng P, Akishita M, Arai H. Sarcopenia in Asia: consensus report of the Asian Working Group for Sarcopenia. J Am Med Dir Assoc. 2014 Feb;15(2):95-101. doi: 10.1016/j.jamda.2013.11.025.

  PMID: 24461239 BACKGROUND

• Li MCM, Cheng YK, Cui C, Chow SKH, Wong RMY, Kwok TC, Siu PM, Yang M, Tian M, Rubin C, Welch AA, Qin L, Law SW, Cheung WH. Biophysical and nutritional combination treatment for myosteatosis in patients with sarcopenia: a study protocol for single-blinded randomised controlled trial. BMJ Open. 2024 Jan 4;14(1):e074858. doi: 10.1136/bmjopen-2023-074858.

  PMID: 38176874 DERIVED

MeSH Terms

Conditions

Sarcopenia; Musculoskeletal Abnormalities

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Musculoskeletal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Wing Hoi Cheung, PhD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wing Hoi Cheung, PhD

CONTACT

35052715; louischeung@cuhk.edu.hk

Meng Chen Michelle Li, PhD

CONTACT

35053312; michellemcli@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Subjects will be randomized to either (1) Control, (2) HMB only, (3) VT only or (4) HMB +VT group. All subjects will be given protein supplement to ensure minimal daily protein intake. Subject assigned to VT group will receive VT (35Hz, 0.3g, 20min/day, at least 3 times/week) for 6 months. Subjects assigned to HMB group will take HMB capsules 3g/day for 6 months.

Study Record Dates

• First Submitted: August 30, 2022
• First Posted: September 1, 2022
• Study Start: January 12, 2023
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (3)