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NCT Number: NCT05525039

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

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.

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Key information

Conditions

Sarcopenia Atrophy Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases in Old Age Muscular Atrophy Musculoskeletal Abnormalities Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Evangelical Luthera Church Social Service - Hong Kong, Hong Kong

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

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

Treatment and study plan

Low-magnitude High-frequency Vibration

Device

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

Other names: Vibration Treatment

β-hydroxy β-methylbutyrate (HMB) supplement

Dietary Supplement

Oral nutritional HMB supplement at 3g/day

Protein Supplement

Dietary Supplement

Daily protein supplement intake

Primary outcomes

  1. Muscle strength-handgrip

    Time frame: 6 months

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

  2. Muscle performance-gait speed

    Time frame: 6 months

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

Secondary outcomes

  1. Dual energy x-ray absortiometry (DXA)

    Time frame: 6 months

    Whole body muscle mass measurement

  2. Biodex Balance System-LOS

    Time frame: 6 months

    Limits of stability will be recorded to evaluate the dynamic posture stability. Maximum scores will be 100 where the higher scores indicate better performance.

  3. Biodex Balance System-OSI

    Time frame: 6 months

    Posture stability (Overall Stability Index) will be recorded. High scores indicate poorer balancing abillity.

  4. Time-up-and-go test (TUG)

    Time frame: 6 months

    Time will be recorded for participants to rise from a chair, walk 3 meters, turn around, and walk back to the chair then sitting down

  5. 36-item Short-Form Health Survey (SF-36)

    Time frame: 6 months

    Health-related quality of life will be assessed by the validated Chinese version of SF-36. Scores range from 0 to 100 where higher scores indicate better health status

Study contacts

Contact information is provided by the study sponsor or research team.

Meng Chen Michelle Li, PhD

CONTACT

[email protected]

35053312

Wing Hoi Cheung, PhD

CONTACT

[email protected]

35052715

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Collaborators

  • Abbott

Registry information

Official study title

Dissecting the Therapeutic Mechanism of an Effective Combination Treatment Targeting Neuromuscular Junction Dengeneration and Myosteatosis to Combat Sarcopenia

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 1, 2022
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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