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

NCT ID: NCT05525039

Last Updated: 2025-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-12

Study Completion Date

2025-09-30

Brief Summary

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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.

Detailed Description

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In this study, a single-blinded RCT is to investigate the effect of combination treatment of VT and HMB on hand grip, gait speed, muscle mass (DXA) in sarcopenic subjects.

Subjects over age of 65 will be screened by performing SARC-F, handgrip, gait speed and bioelectric impedance assessment (BIA) based on AWGS definition. The participants failed in AWGS algorithm will be invited to join the research. Exclusion criteria are those with (1)pathological bone diseases, (2) chronic inflammatory conditions (e.g. rheumatoid arthritis), (3) neurological problems affecting gait, (4) taking regular supervised exercise training for more than 3 times/week, (5) chair-bound or bed-bound, and (6) malignancy.

Recruited 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. Subjects assigned to HMB+VT group will recieve both VT and HMB supplements for 6 months. The primary outcome is muscle strength showing subjects' functional ability. All primary and secondary outcome assessments for all groups will be performed in the investigators' institute at baseline, 3 months and 6 months post-treatment.

Conditions

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Sarcopenia Connective Tissue Diseases in Old Age Musculoskeletal Abnormalities

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control Group

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

Group Type PLACEBO_COMPARATOR

Protein supplement

Intervention Type DIETARY_SUPPLEMENT

Daily protein supplement intake

HMB only Group

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

Group Type ACTIVE_COMPARATOR

β-hydroxy β-methylbutyrate (HMB) supplement

Intervention Type DIETARY_SUPPLEMENT

Oral nutritional HMB supplement at 3g/day

Protein supplement

Intervention Type DIETARY_SUPPLEMENT

Daily protein supplement intake

VT only Group

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

Group Type ACTIVE_COMPARATOR

Low-magnitude High-frequency Vibration

Intervention Type DEVICE

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

Protein supplement

Intervention Type DIETARY_SUPPLEMENT

Daily protein supplement intake

HMB + VT Group

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.

Group Type EXPERIMENTAL

Low-magnitude High-frequency Vibration

Intervention Type DEVICE

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

β-hydroxy β-methylbutyrate (HMB) supplement

Intervention Type DIETARY_SUPPLEMENT

Oral nutritional HMB supplement at 3g/day

Protein supplement

Intervention Type DIETARY_SUPPLEMENT

Daily protein supplement intake

Interventions

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Low-magnitude High-frequency Vibration

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

Intervention Type DEVICE

β-hydroxy β-methylbutyrate (HMB) supplement

Oral nutritional HMB supplement at 3g/day

Intervention Type DIETARY_SUPPLEMENT

Protein supplement

Daily protein supplement intake

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Vibration Treatment

Eligibility Criteria

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Inclusion Criteria

* Subjects aged 60 years or above
* Subjects failed in AWGS algorithm

1. skeletal muscle mass by BIA (male at \<7.0 kg/m\^2, female at \<5.7 kg/m\^2), and
2. handgrip strength (male at \<28 kg, female at \<18kg), and/or
3. gait speed test (\>1m/s)

Exclusion Criteria

* 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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role collaborator

Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Professor CHEUNG Wing hoi, Louis

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wing Hoi Cheung, PhD

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

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Evangelical Luthera Church Social Service - Hong Kong

Hong Kong, , Hong Kong

Site Status ACTIVE_NOT_RECRUITING

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

Hong Kong, , Hong Kong

Site Status 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

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Wing Hoi Cheung, PhD

Role: CONTACT

Meng Chen Michelle Li, PhD

Role: CONTACT

Facility Contacts

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Zhihui Lu, PhD

Role: primary

Meng Chen Michelle Li, PhD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 24676848 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31994349 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23514626 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17601464 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30462162 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24461239 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38176874 (View on PubMed)

Other Identifiers

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CREC 2022.233-T

Identifier Type: -

Identifier Source: org_study_id

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