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

Not Applicable

Recruiting

• Conditions: Musculoskeletal Abnormalities; Sarcopenia; Connective Tissue Diseases in Old Age
• Interventions: Device: Low-magnitude High-frequency Vibration; Dietary Supplement: β-hydroxy β-methylbutyrate (HMB) supplement; Dietary Supplement: Protein supplement

• Registration Number: NCT05525039
• Lead Sponsor: Chinese University of Hong Kong

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-08-30
• Study First Submitted QC: 2022-08-30
• Study First Posted: 2022-09-01
• Study Start: 2023-01-12
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-06
• Last Update Posted: 2023-02-08
• Primary Completion: 2024-10
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Subjects aged 65 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 <26 kg, female at <18kg), and/or
  3. gait speed test (<1m/s)

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HMB only Group	Protein supplement	Subjects assigned to HMB only Group will receive HMB supplement at 3g/day and daily protein supplement for 6 months.
VT only Group	Low-magnitude High-frequency Vibration	Subjects assigned to VT only Group will receive VT (0.3g, 35Hz, at least 3 times/week) and daily protein supplement for 6 months
VT only Group	Protein supplement	Subjects assigned to VT only Group will receive VT (0.3g, 35Hz, at least 3 times/week) and daily protein supplement for 6 months
Control Group	Protein supplement	Subjects assigned to Contro Group will not receive VT or HMB. They will receive daily protein supplement for 6 months.
HMB + VT Group	Low-magnitude High-frequency Vibration	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.
HMB only Group	β-hydroxy β-methylbutyrate (HMB) supplement	Subjects assigned to HMB only Group will receive HMB supplement at 3g/day and daily protein supplement for 6 months.
HMB + VT Group	β-hydroxy β-methylbutyrate (HMB) supplement	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.
HMB + VT Group	Protein supplement	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.

Primary Outcome Measures

Name	Time	Method
Muscle strength-handgrip	6 months	Handgrip strength will be measured by a dynamometer on each hand of the subject.
Muscle performance-gait speed	6 months	Gait speed will be assessed by a 6-meter-walk test.

Secondary Outcome Measures

Name	Time	Method
Dual energy x-ray absortiometry (DXA)	6 months	Whole body muscle mass measurement
Biodex Balance System-LOS	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.
Time-up-and-go test (TUG)	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
Biodex Balance System-OSI	6 months	Posture stability (Overall Stability Index) will be recorded. High scores indicate poorer balancing abillity.
36-item Short-Form Health Survey (SF-36)	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

Trial Locations

Locations (3)

The Chinese University of Hong Kong Jockey Club Centre for Osteoporosis Care and Control; 🇭🇰 Hong Kong, Hong Kong

Evangelical Luthera Church Social Service - Hong Kong; 🇭🇰 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