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

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The Chinese University of Hong Kong

Status

Enrolling

Conditions

Connective Tissue Diseases in Old Age
Musculoskeletal Abnormalities
Sarcopenia

Treatments

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

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

65+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects aged 65 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 <26 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

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

Trial contacts and locations

0

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Central trial contact

Meng Chen Michelle Li, PhD; Wing Hoi Cheung, PhD

Data sourced from clinicaltrials.gov

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