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Dissecting the therapeutic mechanism of an effective combination treatment targeting neuromuscular junction dengeneration and myosteatosis to combat sarcopenia

NCT ID NCT05525039

Sponsor: Chinese University of Hong Kong Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Oct 21, 2026 · Last updated Oct 22, 2026 · Updated 1 time

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.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

200 people

The number who actually took part.

Started

Jan 2023

Finished

May 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Musculoskeletal Abnormalities Sarcopenia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Connective tissue diseases in old age Musculoskeletal abnormalities Sarcopenia

Contacts and locations

Locations

  • Evangelical Luthera Church Social Service - Hong Kong

    Hong Kong, Hong Kong

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

    Hong Kong, Hong Kong

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

    Hong Kong, Hong Kong

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