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

February 6, 2023 updated by: Professor CHEUNG Wing hoi, Louis, Chinese University of Hong Kong

Dissecting the Therapeutic Mechanism of an Effective Combination Treatment Targeting Neuromuscular Junction Dengeneration and Myosteatosis to Combat Sarcopenia

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • The Chinese University of Hong Kong Jockey Club Centre for Osteoporosis Care and Control
      • Hong Kong, Hong Kong
        • Active, not recruiting
        • Evangelical Luthera Church Social Service - Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • The Chinese University of Hong Kong, Department of Orthopaedics and Traumatology, 1/F Li Ka Shing Outpatient Clinic (North), PWH
        • Contact:
          • Meng Chen Michelle Li, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Control Group
Subjects assigned to Contro Group will not receive VT or HMB. They will receive daily protein supplement for 6 months.
Dietary supplement: Protein supplement
Daily protein supplement intake
ACTIVE_COMPARATOR: HMB only Group
Subjects assigned to HMB only Group will receive HMB supplement at 3g/day and daily protein supplement for 6 months.
Dietary supplement: Protein supplement
Daily protein supplement intake
Dietary supplement: β-hydroxy β-methylbutyrate (HMB) supplement
Oral nutritional HMB supplement at 3g/day
ACTIVE_COMPARATOR: VT only Group
Subjects assigned to VT only Group will receive VT (0.3g, 35Hz, at least 3 times/week) and daily protein supplement for 6 months
Dietary supplement: Protein supplement
Daily protein supplement intake
Device: Low-magnitude High-frequency Vibration
0.3g, 35Hz, 20mins/day, at least 3 times/week
Other Names:
  • Vibration Treatment
EXPERIMENTAL: HMB + VT Group
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.
Dietary supplement: Protein supplement
Daily protein supplement intake
Dietary supplement: β-hydroxy β-methylbutyrate (HMB) supplement
Oral nutritional HMB supplement at 3g/day
Device: Low-magnitude High-frequency Vibration
0.3g, 35Hz, 20mins/day, at least 3 times/week
Other Names:
  • Vibration Treatment

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Collaborators

Abbott

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 12, 2023

Primary Completion (ANTICIPATED)

October 1, 2024

Study Completion (ANTICIPATED)

April 1, 2025

Study Registration Dates

First Submitted

August 30, 2022

First Submitted That Met QC Criteria

August 30, 2022

First Posted (ACTUAL)

September 1, 2022

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 6, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CREC 2022.233-T

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sarcopenia

Clinical Trials on Protein supplement

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cyprus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe