Health TrialsbyHealthPanel

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

ConditionsSarcopeniaConnective Tissue Diseases in Old AgeMusculoskeletal Abnormalities
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorChinese University of Hong Kong

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects aged 60 years or above

Subjects failed in AWGS algorithm

skeletal muscle mass by BIA (male at <7.0 kg/m², female at <5.7 kg/m²), and

handgrip strength (male at <28 kg, female at <18kg), and/or

Disqualifiers

Subjects with pathological bone diseases

Subjects with chronic inflammatory condition (e.g. rheumatoid arthritis)

Subjects with neurological problems

Subjects receiving regular exercise

Trial design

Design model

Parallel

Treatments tested in this trial

  • Low-magnitude High-frequency Vibration

    Device

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

  • β-hydroxy β-methylbutyrate (HMB) supplement

    Dietary supplement

    Oral nutritional HMB supplement at 3g/day

  • Protein supplement

    Dietary supplement

    Daily protein supplement intake

Treatment groups

200 Participants
are divided into 4 treatment groups
Group A: Control GroupPlacebo comparator 1 intervention
Group B: HMB only GroupActive comparator 2 interventions
Group C: VT only GroupActive comparator 2 interventions
Group D: HMB + VT GroupExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Muscle strength-handgrip

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

Time frame
6 months
2

Muscle performance-gait speed

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

Time frame
6 months

Secondary outcomes

1

Dual energy x-ray absortiometry (DXA)

Whole body muscle mass measurement

Time frame
6 months
2

Biodex Balance System-LOS

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

Time frame
6 months
3

Biodex Balance System-OSI

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

Time frame
6 months
4

Time-up-and-go test (TUG)

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

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chinese University of Hong Kong

Lead sponsor

Abbott

Collaborator

Source ClinicalTrials.gov
Apply now