TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status

Summary

The purpose of this study is to compare the effects of a standardized Traditional Chinese Medicine (TCM) formula versus beta-hydroxy-beta-methylbutyrate (HMB) on muscle strength and bone health in pre-frail older adults . Pre-frailty is a critical stage where functional decline may still be reversed through proper intervention. The study will enroll 90 participants aged 65 years or older who meet the criteria for pre-frailty. Participants will be randomly assigned to either the TCM group (receiving a standardized herbal powder formula) or the HMB group (receiving nutritional supplement tablets) for 24 weeks . The primary objective is to evaluate the change in handgrip strength from baseline to Week 12 . Researchers will also assess changes in skeletal muscle mass, bone mineral density, and overall physical performance . The goal is to determine if the TCM formula is an effective alternative or complementary intervention for managing geriatric frailty.

Timeline

Start

2026-04-02

Primary completion

2026-10-31

Completion

2026-12-31

Publications

• Background Yoo JI, Choi H, Ha YC. Mean Hand Grip Strength and Cut-off Value for Sarcopenia in Korean Adults Using KNHANES VI. J Korean Med Sci. 2017 May;32(5):868-872. doi: 10.3346/jkms.2017.32.5.868.
• Background Soares LA, Lima LP, Prates ACN, Arrieiro AN, Da Costa Teixeira LA, Duarte TC, Dos Santos JM, da Silva Lage VK, de Paula FA, Costa HS, Figueiredo PHS, de Almeida VMTL, de Sara Abreu N, Costa SP, Brant FP, Lima RR, Thomasini RL, Pereira LSM, Pereira FSM, Parentoni AN, de Avelar NCP, Leopoldino AAO, Mendonca VA, Lacerda ACR. Accuracy of handgrip and respiratory muscle strength in identifying sarcopenia in older, community-dwelling, Brazilian women. Sci Rep. 2023 Jan 27;13(1):1553. doi: 10.1038/s41598-023-28549-5.
• Background Blanquet M, Ducher G, Sauvage A, Dadet S, Guiyedi V, Farigon N, Guiguet-Auclair C, Berland P, Bohatier J, Boirie Y, Gerbaud L. Handgrip strength as a valid practical tool to screen early-onset sarcopenia in acute care wards: a first evaluation. Eur J Clin Nutr. 2022 Jan;76(1):56-64. doi: 10.1038/s41430-021-00906-5. Epub 2021 Apr 13.
• Background Vaishya R, Misra A, Vaish A, Ursino N, D'Ambrosi R. Hand grip strength as a proposed new vital sign of health: a narrative review of evidences. J Health Popul Nutr. 2024 Jan 9;43(1):7. doi: 10.1186/s41043-024-00500-y.
• Background Dwimartutie N, Setiati S, Tamin TZ, Prijanti AR, Harahap AR, Purnamasari D, Harimurti K, Pramantara IDP, Suwarto S, Kojima T. Effect of cholecalciferol supplementation on hand grip strength, walking speed, and expression of vitamin D receptor, interleukin-6, and insulin-like growth factor-1 in monocyte in pre-frail older adults: A randomized double-blind placebo-controlled trial. Geriatr Gerontol Int. 2024 Jun;24(6):554-562. doi: 10.1111/ggi.14881. Epub 2024 Apr 21.
• Background Castell MV, Sanchez M, Julian R, Queipo R, Martin S, Otero A. Frailty prevalence and slow walking speed in persons age 65 and older: implications for primary care. BMC Fam Pract. 2013 Jun 19;14:86. doi: 10.1186/1471-2296-14-86.
• Background Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
• Background Nari F, Park EC, Nam CM, Jang SI. Impact of frailty on mortality and healthcare costs and utilization among older adults in South Korea. Sci Rep. 2023 Dec 1;13(1):21203. doi: 10.1038/s41598-023-48403-y.
• Background Alvarez-Bustos A, Rodriguez-Sanchez B, Carnicero-Carreno JA, Sepulveda-Loyola W, Garcia-Garcia FJ, Rodriguez-Manas L. Healthcare cost expenditures associated to frailty and sarcopenia. BMC Geriatr. 2022 Sep 13;22(1):747. doi: 10.1186/s12877-022-03439-z.
• Background Peng LN, Cheng YC, Yu PC, Lee WJ, Lin MH, Chen LK. Oral Nutritional Supplement with beta-hydroxy-beta-methylbutyrate (HMB) Improves Nutrition, Physical Performance and Ameliorates Intramuscular Adiposity in Pre-Frail Older Adults: A Randomized Controlled Trial. J Nutr Health Aging. 2021;25(6):767-773. doi: 10.1007/s12603-021-1621-7.
• Background Yang C, Song Y, Li T, Chen X, Zhou J, Pan Q, Jiang W, Wang M, Jia H. Effects of Beta-Hydroxy-Beta-Methylbutyrate Supplementation on Older Adults with Sarcopenia: A Randomized, Double-Blind, Placebo-Controlled Study. J Nutr Health Aging. 2023;27(5):329-339. doi: 10.1007/s12603-023-1911-1.
• Background Takayama S, Tomita N, Arita R, Ono R, Kikuchi A, Ishii T. Kampo Medicine for Various Aging-Related Symptoms: A Review of Geriatric Syndrome. Front Nutr. 2020 Jul 15;7:86. doi: 10.3389/fnut.2020.00086. eCollection 2020.
• Background Buto MSS, de Oliveira MPB, Carvalho C, Vassimon-Barroso V, Takahashi ACM. Effect of complementary therapies on functional capacity and quality of life among prefrail and frail older adults: A systematic review of randomized controlled trials. Arch Gerontol Geriatr. 2020 Nov/Dec;91:104236. doi: 10.1016/j.archger.2020.104236. Epub 2020 Aug 21.
• Background Yakabe M, Hosoi T, Sasakawa H, Akishita M, Ogawa S. Kampo formula hochu-ekki-to (Bu-Zhong-Yi-Qi-Tang, TJ-41) ameliorates muscle atrophy by modulating atrogenes and AMPK in vivo and in vitro. BMC Complement Med Ther. 2022 Dec 28;22(1):341. doi: 10.1186/s12906-022-03812-w.
• Background Schonenberg A, Heimrich KG, Sternkopf A, Lochbihler P, Prell T. Patient-reported geriatric syndromes and their association with quality of life: findings from a cross-sectional study in German older adults. Eur Geriatr Med. 2026 Apr;17(2):721-733. doi: 10.1007/s41999-025-01332-7. Epub 2025 Oct 16.

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