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

The Chinese University of Hong Kong

Status: Enrolling

Conditions: Connective Tissue Diseases in Old Age; Musculoskeletal Abnormalities; Sarcopenia

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05525039

CREC 2022.233-T

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 4 patient groups, including a placebo group

Control Group

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Protein supplement

HMB only Group

Active Comparator group

Description:

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

Treatment:

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

Dietary Supplement: Protein supplement

VT only Group

Active Comparator group

Description:

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

Treatment:

Device: Low-magnitude High-frequency Vibration

Dietary Supplement: Protein supplement

HMB + VT Group

Experimental group

Description:

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.

Treatment:

Device: Low-magnitude High-frequency Vibration

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

Dietary Supplement: Protein supplement