A Phase 2 interventional study of TCM Formula and HMB (beta-Hydroxy-beta-methylbutyrate) in Pre-Frailty, Sarcopenia and Muscle Atrophy or Weakness, sponsored by Tri-Service General Hospital (TSGH). Recruiting at 1 site in Taiwan. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-05-19.
Sponsored by Tri-Service General Hospital (TSGH) · Phase 2, Interventional, and Treatment
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.
This is a randomized, open-label, parallel-group comparative study designed to evaluate the clinical efficacy and safety of a standardized Traditional Chinese Medicine formula versus beta-hydroxy-beta-methylbutyrate supplementation in pre-frail older adults . Pre-frailty is identified as a reversible stage between robust health and frailty. This study aims to provide clinical evidence for the Traditional Chinese Medicine formula as an intervention to improve muscle strength, bone health, and physical function. Eligible participants aged 65 years or older who meet 1 to 2 of the 5 Fried frailty phenotype criteria will be randomized in a 1 to 1 ratio. The total study duration for each participant is approximately 26 weeks, including a screening period and a 24-week intervention period. Participants in the Traditional Chinese Medicine group receive a standardized herbal powder formula designed to tonify Qi, Blood, Liver, and Kidney. The total daily dosage is 18 grams, administered as 9 grams twice daily, taken 30 minutes before breakfast and lunch. Participants in the HMB group receive a total daily dose of 3 grams of beta-hydroxy-beta-methylbutyrate, administered as two 0.75-gram tablets twice daily after breakfast and lunch. The primary endpoint is the change from baseline in handgrip strength at Week 12 . Secondary endpoints assessed at Week 12 and Week 24 include changes in skeletal muscle mass, bone mineral density, body fat percentage, gait speed using a 6-meter test, Timed Up and Go test, Five Times Sit-to-Stand test, Fried frailty phenotype status, Clinical Frailty Scale scores, and SF-12 quality of life scores . Safety is monitored throughout the study by assessing adverse events and changes in laboratory parameters, including complete blood count, liver and renal function, and urinalysis . A total of 90 participants (45 per group) is required based on a non-inferiority t-test for the primary endpoint. The calculation assumed a power of 80 percent and a one-sided significance level of 0.025, accounting for an estimated 20 percent dropout rate.
Exclusion Criteria:
Participants will receive a standardized Traditional Chinese Medicine herbal powder formula. This formula is designed to tonify Qi, Blood, Liver, and Kidney to enhance physical function in elders. The daily dosage is 18 grams, administered as one 9-gram sachet twice daily. It is taken 30 minutes before breakfast and lunch for 24 consecutive weeks.
Drug: TCM Formula
Participants will receive beta-hydroxy-beta-methylbutyrate (HMB) as an active control. The intervention consists of a total daily dose of 3 grams, administered as two 0.75-gram tablets twice daily. The tablets are to be taken after breakfast and lunch for 24 consecutive weeks.
Dietary Supplement: HMB (beta-Hydroxy-beta-methylbutyrate)
A scientific TCM herbal powder formula prepared by the hospital pharmacy. The formula consists of 10 botanical ingredients focused on tonifying Qi, Blood, Liver, and Kidney. Participants will receive a total daily dose of 18 grams, administered as 9 grams twice daily (BID), 30 minutes before breakfast and lunch.
Also known as: TCM
The active ingredient is beta-hydroxy-beta-methylbutyrate (HMB), provided in 0.75g tablets. Participants will take 2 tablets twice daily (BID) after breakfast and lunch, resulting in a total daily dose of 3 grams. This is a common clinical dose used as a nutritional intervention for muscle strength and physical performance.
Also known as: HMB
Change from Baseline in Hand Grip Strength at Week 12
Hand grip strength is used as a functional biomarker to reflect overall muscle strength. Measurement will be performed using a standardized JAMAR dynamometer. Participants will follow a standardized procedure: seated position, elbow flexed at 90 degrees, with the forearm in a neutral position using the dominant hand. The "Change" is calculated as the value at Week 12 minus the baseline value . Higher values indicate improved muscle strength.
Time frame: Baseline and Week 12
Change in Hand Grip Strength at Week 24
Change from baseline in hand grip strength at Week 24. Measurement is performed using a standardized JAMAR dynamometer with the dominant hand. Higher values indicate better muscle strength.
Time frame: Baseline and Week 24.
Change in Skeletal Muscle Mass
Change from baseline in skeletal muscle mass measured by Bioelectrical Impedance Analysis (BIA). This reflects structural changes in muscle quantity.
Time frame: Baseline, Week 12, and Week 24.
Change in Calf Circumference
Change from baseline in calf circumference measured at the widest part of the calf using a soft tape. It serves as a proxy indicator for lower limb muscle mass.
Time frame: Baseline, Week 12, and Week 24.
Change in Gait Speed
Change from baseline in gait speed using the 6-meter gait speed test. Participants walk at a normal pace, and the time taken is recorded to reflect functional mobility.
Time frame: Baseline, Week 12, and Week 24.
Change in Timed Up and Go (TUG) Test Time
Change from baseline in the time required to rise from a chair, walk 3 meters, turn, return, and sit down again. This test evaluates dynamic balance and agility.
Time frame: Baseline, Week 12, and Week 24.
Change in Five Times Sit-to-Stand (5xSTS) Test Time
Change from baseline in the time taken to complete five consecutive sit-to-stand cycles as quickly as possible. This reflects lower limb muscle power and endurance.
Time frame: Baseline, Week 12, and Week 24.
Change in Fried Frailty Phenotype Status
Change from baseline in frailty status categorized as Robust (0 criteria), Pre-frail (1-2 criteria), or Frail (3-5 criteria) based on 5 indicators: grip strength, walking speed, exhaustion, weight loss, and physical activity.
Time frame: Baseline, Week 12, and Week 24.
Change in Clinical Frailty Scale (CFS) Score
Change from baseline in the Clinical Frailty Scale score, which ranges from 1 (Very Fit) to 9 (Terminally Ill). It provides a holistic clinical assessment of frailty level.
Time frame: Baseline, Week 12, and Week 24.
Change in Bone Mineral Density (BMD)
Change from baseline in bone mineral density measured by Dual-energy X-ray Absorptiometry (DXA, Lunar iDXA).
Time frame: Baseline, Week 12, and Week 24.
Change in Body Fat Percentage
Change from baseline in body fat percentage analyzed using DXA (Lunar iDXA). This reflects changes in body composition related to metabolic health.
Time frame: Baseline, Week 12, and Week 24.
Change in SF-12 Quality of Life Score
Change from baseline in the 12-Item Short Form Health Survey (SF-12) scores. Higher scores represent better health-related quality of life.
Time frame: Baseline, Week 12, and Week 24.
Incidence of Treatment-Emergent Adverse Events (Safety)
Number of participants with treatment-emergent adverse events (AEs) and serious adverse events (SAEs) . AEs will be assessed for severity (mild, moderate, or severe) and their causal relationship to the study interventions (TCM formula or HMB supplement).
Time frame: Baseline up to Week 24.
Number of Participants With Clinically Significant Laboratory Abnormalities
Number of participants with laboratory values that are outside the reference range and judged by the investigator to be clinically significant. Laboratory assessments include: Complete Blood Count (CBC); Liver function (ALT, AST, Albumin); Renal function (BUN, Creatinine, eGFR, Uric acid); Electrolytes (Na, K, Ca, Mg); Fasting blood glucose; and General Urinalysis (protein, glucose, urobilinogen, bilirubin, sediment, specific gravity, pH, occult blood) .
Time frame: Baseline up to Week 24
Plan to share: No — Individual participant data collected during the trial will not be shared with the general public. According to the study protocol, all research data and intellectual property are jointly owned by the National Research Institute of Chinese Medicine and Tri-Service General Hospital. To protect participant privacy and maintain strict confidentiality, access to de-identified participant data is limited to the principal investigator and authorized research team members. Direct access to original records is permitted only for the trial sponsor, the Institutional Review Board, and regulatory authorities for the purposes of monitoring and auditing to ensure compliance with Good Clinical Practice and relevant data protection laws. There is currently no plan to make the individual participant data available to external researchers or the public to maintain the highest standards of participant confidentiality and protect the research interests of the participating institutions.
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Tri-Service General Hospital (TSGH)