Sarcopenia Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | April 2025 |
Est. primary completion date | October 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Evangelical Luthera Church Social Service - Hong Kong | Hong Kong | |
Hong Kong | The Chinese University of Hong Kong Jockey Club Centre for Osteoporosis Care and Control | 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 |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong | Abbott |
Hong Kong,
Chen LK, Liu LK, Woo J, Assantachai P, Auyeung TW, Bahyah KS, Chou MY, Chen LY, Hsu PS, Krairit O, Lee JS, Lee WJ, Lee Y, Liang CK, Limpawattana P, Lin CS, Peng LN, Satake S, Suzuki T, Won CW, Wu CH, Wu SN, Zhang T, Zeng P, Akishita M, Arai H. Sarcopenia in Asia: consensus report of the Asian Working Group for Sarcopenia. J Am Med Dir Assoc. 2014 Feb;15(2):95-101. doi: 10.1016/j.jamda.2013.11.025. — View Citation
Cheung WH, Mok HW, Qin L, Sze PC, Lee KM, Leung KS. High-frequency whole-body vibration improves balancing ability in elderly women. Arch Phys Med Rehabil. 2007 Jul;88(7):852-7. doi: 10.1016/j.apmr.2007.03.028. — View Citation
Deutz NE, Pereira SL, Hays NP, Oliver JS, Edens NK, Evans CM, Wolfe RR. Effect of beta-hydroxy-beta-methylbutyrate (HMB) on lean body mass during 10 days of bed rest in older adults. Clin Nutr. 2013 Oct;32(5):704-12. doi: 10.1016/j.clnu.2013.02.011. Epub 2013 Mar 4. — View Citation
Leung KS, Li CY, Tse YK, Choy TK, Leung PC, Hung VW, Chan SY, Leung AH, Cheung WH. Effects of 18-month low-magnitude high-frequency vibration on fall rate and fracture risks in 710 community elderly--a cluster-randomized controlled trial. Osteoporos Int. 2014 Jun;25(6):1785-95. doi: 10.1007/s00198-014-2693-6. Epub 2014 Mar 28. — View Citation
Wang J, Cui C, Chim YN, Yao H, Shi L, Xu J, Wang J, Wong RMY, Leung KS, Chow SK, Cheung WH. Vibration and beta-hydroxy-beta-methylbutyrate treatment suppresses intramuscular fat infiltration and adipogenic differentiation in sarcopenic mice. J Cachexia Sarcopenia Muscle. 2020 Apr;11(2):564-577. doi: 10.1002/jcsm.12535. Epub 2020 Jan 28. — View Citation
Zhu LY, Chan R, Kwok T, Cheng KC, Ha A, Woo J. Effects of exercise and nutrition supplementation in community-dwelling older Chinese people with sarcopenia: a randomized controlled trial. Age Ageing. 2019 Mar 1;48(2):220-228. doi: 10.1093/ageing/afy179. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Muscle strength-handgrip | Handgrip strength will be measured by a dynamometer on each hand of the subject. | 6 months | |
Primary | Muscle performance-gait speed | Gait speed will be assessed by a 6-meter-walk test. | 6 months | |
Secondary | Dual energy x-ray absortiometry (DXA) | Whole body muscle mass measurement | 6 months | |
Secondary | 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. | 6 months | |
Secondary | Biodex Balance System-OSI | Posture stability (Overall Stability Index) will be recorded. High scores indicate poorer balancing abillity. | 6 months | |
Secondary | 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 | 6 months | |
Secondary | 36-item Short-Form Health Survey (SF-36) | 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 |
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