Pre-FrailtyPhase 2TCM-HMB-PFNCT07597850

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

A Phase 2 study testing TCM Formula and HMB (beta-Hydroxy-beta-methylbutyrate) in people with Pre-Frailty and Sarcopenia, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

Who is it for?: Ages 65 years and older
Conditions the study is for: Pre-Frailty, Sarcopenia, Muscle Atrophy or Weakness
What is being tested?: TCM Formula and HMB (beta-Hydroxy-beta-methylbutyrate)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 90 participants
Where: 1 siteTaiwan
Study dates: 2 Apr 2026to 31 Dec 2026
Phase: Phase 2
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

Male or female participants aged 65 years or older at the time of screening.
Body Mass Index less than 30 kilograms per square meter.
Identified as pre-frail according to the Fried frailty phenotype, meeting 1 to 2 of the following 5 criteria: 1) Hand grip strength below specific thresholds based on gender and Body Mass Index. For males, Body Mass Index 24 or less is 29 kilograms or less, Body Mass Index 24.1 to 28 is 30 kilograms or less, Body Mass Index greater than 28 is 32 kilograms or less. For females, Body Mass Index 23 or less is 17 kilograms or less, Body Mass Index 23.1 to 26 is 17.3 kilograms or less, Body Mass Index 26.1 to 29 is 18 kilograms or less, Body Mass Index greater than 29 is 21 kilograms or less. 2) Slow walking speed. For a 4-meter distance, walking time of 7 seconds or more for males 173 centimeters or shorter, or 6 seconds or more for males taller than 173 centimeters. For females 159 centimeters or shorter, 7 seconds or more, or 6 seconds or more for females taller than 159 centimeters. 3) Self-reported exhaustion. Answering 3 days or more per week to either feeling that everything was an effort or could not get going in the past week. 4) Unintentional weight loss. Loss of 3 kilograms or more or more than 5 percent of body weight in the past year. 5) Low physical activity. Weekly energy expenditure less than 383 kilocalories for males or less than 270 kilocalories for females.
Ability to safely complete a 6-meter walk test in a single attempt without assistance or using only simple aids such as a cane.
Clinically stable condition allowing for follow-up visits every 4 weeks and participation in all study-related assessments.
Willingness to provide existing test data from within 90 days prior to randomization, including Bone Mineral Density by DXA and serum biochemistry or urinalysis results.
Sufficient cognitive function to understand the study and sign the informed consent form, or with the assistance of a legal representative.
Willingness to maintain existing diet and exercise habits during the study and not start high-intensity exercise programs or large amounts of nutritional supplements.

Who cannot join

Major acute illness such as acute myocardial infarction, pneumonia, or acute stroke within 2 weeks prior to screening.
Major organ dysfunction, including renal function with estimated glomerular filtration rate less than 45 milliliters per minute per 1.73 square meters within 1 month prior to screening, liver function with AST or ALT greater than 3 times the upper limit of normal within 1 month prior to screening, NYHA Class III or IV heart failure, or severe COPD requiring long-term oxygen therapy.
Unplanned hospitalization within 1 month prior to screening, or major surgery with incomplete functional recovery within 3 months prior to screening.
Current malignant tumor under treatment, or less than 12 months since the completion of cancer treatment.
Use of supplements containing the same ingredients as the study interventions, or products that may affect the primary endpoint including HMB, creatine, branched-chain amino acids, or high-dose protein powder within 4 weeks prior to screening.
Known significant clinical allergy or hypersensitivity to any components of the study formula or HMB nutritional supplement.

Show all 10Show fewer

Moderate to severe dementia, severe depression, or other psychiatric disorders resulting in inability to cooperate without a legal representative.
Participation in other interventional clinical trials involving drugs, biologics, or nutritional supplements within 3 months prior to screening.
New initiation or dose adjustment of medications affecting muscle or bone metabolism within 3 months prior to screening, including systemic glucocorticoids, anabolic steroids, testosterone, or growth hormones.
Any other condition that, in the opinion of the investigator, makes the participant unsuitable for the study due to safety or compliance concerns.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

Tri-Service General Hospital
Taipei, 114202

Other trials in Taiwan

About this study

Official title: Effects of Traditional Chinese Medicine (TCM) Formula vs. HMB on Muscle Strength and Bone Status in Pre-Frail Elders: A Comparative Study

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.

Read the detailed description

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.

Conditions: Pre-Frailty, Sarcopenia, Muscle Atrophy or Weakness, Osteoporosis, Aging
Being tested: TCM Formula, HMB (beta-Hydroxy-beta-methylbutyrate)
Keywords: Traditional Chinese Medicine, HMB (Hydroxy-beta-methylbutyrate), Muscle Strength, Handgrip Strength, Body Composition, Elderly Health, Randomized Controlled Trial
Medical subject headings: Sarcopenia, Muscular Atrophy, Asthenia, Osteoporosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TCM FormulaDrug
Also called TCM
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.
HMB (beta-Hydroxy-beta-methylbutyrate)Dietary supplement
Also called HMB
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.

Study groups in NCT07597850
Study group	Role	What they receive
Experimental: TCM Group	Experimental	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. Receives: Drug: TCM Formula
Active Comparator: HMB Group	Active comparator	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. Receives: Dietary Supplement: HMB (beta-Hydroxy-beta-methylbutyrate)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline and Week 12

Secondary outcomes (11)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Baseline, Week 12, and Week 24.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Apr 202631 Dec 2026

First posted19 May 2026
Study start2 Apr 2026
Primary completion31 Oct 2026 (estimated)
Study completion31 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (15)Papers the sponsor has linked to this study.
Other trials for Pre-FrailtyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Randomized, parallel-group, active-controlled study with a 1:1 allocation ratio.
Masking: None (open label)
Enrolment: 90 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07597850
Sponsor's protocol ID: MBS-101
Other IDs: 115-1-N001
Acronym: TCM-HMB-PF
Status last verified: Oct 2026
First submitted: 5 May 2026
Last updated: 3 Nov 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: 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.

Publications

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.
PubMed 28378563
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.
PubMed 36707661
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.
PubMed 33850314
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.
PubMed 38195493
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.
PubMed 38644647
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.
PubMed 23782891
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.
PubMed 11253156
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.
PubMed 38040759
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.
PubMed 36096728
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.
PubMed 34179932
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.
PubMed 37248756
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.
PubMed 32766269
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.
PubMed 32860990
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.
PubMed 36578084
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.
PubMed 41099789

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Comparıson of the Effıcacy of Conventıonal Exercıse and Pılates ın Pre-fraıl and Fraıl Older Adults
Frailty Syndrome, Prefrail Elderly
Recruiting
Resistance vs Aerobic Prehabilitation Before Colorectal Cancer Surgery
Colorectal Cancer, Colorectal Neoplasms
Recruiting
Acupoint Stimulation and Exercise for Taiwanese Pre-frail Older Adults
Frailty, Sleep Quality
Not yet recruiting
In-Person, Online, and Hybrid Healthy-Aging Education for Pre-Frailty and Frailty in Older Adults
Frailty, Pre-Frailty
Enrolling by invitation
Targeted Prehabilitation With Physical Exercise and Inspiratory Muscle Training for Elderly Frail Patients Prior to Ventral Hernia Repair
Frailty, Ventral Hernia

All Pre-Frailty trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Traditional Chinese Medicine (TCM) Formula vs. HMB on Muscle Strength and Bone Status in Pre-Frail Elders: A Comparative Study
ClinicalTrials.gov ID: NCT07597850
Acronym / sponsor ID: TCM-HMB-PF / MBS-101
Conditions: Pre-Frailty, Sarcopenia, Muscle Atrophy or Weakness, Osteoporosis, Aging
Keywords: Traditional Chinese Medicine, HMB (Hydroxy-beta-methylbutyrate), Muscle Strength, Handgrip Strength, Body Composition, Elderly Health, Randomized Controlled Trial
Phase: Phase 2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 90 participants (estimated)
Lead sponsor: Tri-Service General Hospital (TSGH)University, hospital or other
Collaborators: National Research Institute of Chinese Medicine, Ministry of Health and Welfare
Study start: 2 Apr 2026 (actual)
Primary completion: 31 Oct 2026 (estimated)
Study completion: 31 Dec 2026 (estimated)
First posted: 19 May 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Randomized, parallel-group, active-controlled study with a 1:1 allocation ratio.

Arm	Type	Receives
Experimental: TCM Group	Experimental	Drug: TCM FormulaParticipants 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.
Active Comparator: HMB Group	Active comparator	Dietary Supplement: HMB (beta-Hydroxy-beta-methylbutyrate)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.

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (8 listed)

Male or female participants aged 65 years or older at the time of screening.
Body Mass Index less than 30 kilograms per square meter.
Identified as pre-frail according to the Fried frailty phenotype, meeting 1 to 2 of the following 5 criteria: 1) Hand grip strength below specific thresholds based on gender and Body Mass Index. For males, Body Mass Index 24 or less is 29 kilograms or less, Body Mass Index 24.1 to 28 is 30 kilograms or less, Body Mass Index greater than 28 is 32 kilograms or less. For females, Body Mass Index 23 or less is 17 kilograms or less, Body Mass Index 23.1 to 26 is 17.3 kilograms or less, Body Mass Index 26.1 to 29 is 18 kilograms or less, Body Mass Index greater than 29 is 21 kilograms or less. 2) Slow walking speed. For a 4-meter distance, walking time of 7 seconds or more for males 173 centimeters or shorter, or 6 seconds or more for males taller than 173 centimeters. For females 159 centimeters or shorter, 7 seconds or more, or 6 seconds or more for females taller than 159 centimeters. 3) Self-reported exhaustion. Answering 3 days or more per week to either feeling that everything was an effort or could not get going in the past week. 4) Unintentional weight loss. Loss of 3 kilograms or more or more than 5 percent of body weight in the past year. 5) Low physical activity. Weekly energy expenditure less than 383 kilocalories for males or less than 270 kilocalories for females.
Ability to safely complete a 6-meter walk test in a single attempt without assistance or using only simple aids such as a cane.
Clinically stable condition allowing for follow-up visits every 4 weeks and participation in all study-related assessments.

Key exclusion criteria (10 listed)

Major acute illness such as acute myocardial infarction, pneumonia, or acute stroke within 2 weeks prior to screening.
Major organ dysfunction, including renal function with estimated glomerular filtration rate less than 45 milliliters per minute per 1.73 square meters within 1 month prior to screening, liver function with AST or ALT greater than 3 times the upper limit of normal within 1 month prior to screening, NYHA Class III or IV heart failure, or severe COPD requiring long-term oxygen therapy.
Unplanned hospitalization within 1 month prior to screening, or major surgery with incomplete functional recovery within 3 months prior to screening.
Current malignant tumor under treatment, or less than 12 months since the completion of cancer treatment.
Use of supplements containing the same ingredients as the study interventions, or products that may affect the primary endpoint including HMB, creatine, branched-chain amino acids, or high-dose protein powder within 4 weeks prior to screening.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TCM FormulaAlso: TCMA 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.	Drug	Experimental: TCM Group
HMB (beta-Hydroxy-beta-methylbutyrate)Also: HMBThe 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.	Dietary supplement	Active Comparator: HMB Group

Primary outcome

Change from Baseline in Hand Grip Strength at Week 12
Time frame: Baseline and 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.

11 secondary outcomes

Change in Hand Grip Strength at Week 24
Time frame: Baseline and Week 24.
Change in Skeletal Muscle Mass
Time frame: Baseline, Week 12, and Week 24.
Change in Calf Circumference
Time frame: Baseline, Week 12, and Week 24.
Change in Gait Speed
Time frame: Baseline, Week 12, and Week 24.
Change in Timed Up and Go (TUG) Test Time
Time frame: Baseline, Week 12, and Week 24.
Change in Five Times Sit-to-Stand (5xSTS) Test Time
Time frame: Baseline, Week 12, and Week 24.
Change in Fried Frailty Phenotype Status
Time frame: Baseline, Week 12, and Week 24.
Change in Clinical Frailty Scale (CFS) Score
Time frame: Baseline, Week 12, and Week 24.
Change in Bone Mineral Density (BMD)
Time frame: Baseline, Week 12, and Week 24.
Change in Body Fat Percentage
Time frame: Baseline, Week 12, and Week 24.
Change in SF-12 Quality of Life Score
Time frame: Baseline, Week 12, and Week 24.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
Background: PubMed 28378563Yoo 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: PubMed 36707661Soares 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: PubMed 33850314Blanquet 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: PubMed 38195493Vaishya 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: PubMed 38644647Dwimartutie 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: PubMed 23782891Castell 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: PubMed 11253156Fried 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: PubMed 38040759Nari 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: PubMed 36096728Alvarez-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: PubMed 34179932Peng 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: PubMed 37248756Yang 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: PubMed 32766269Takayama 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.
Individual participant dataSharing planned: 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.

Related trials for Pre-Frailty

Recruiting
Comparıson of the Effıcacy of Conventıonal Exercıse and Pılates ın Pre-fraıl and Fraıl Older Adults
Frailty Syndrome, Prefrail Elderly
Recruiting
Resistance vs Aerobic Prehabilitation Before Colorectal Cancer Surgery
Colorectal Cancer, Colorectal Neoplasms
Recruiting
Acupoint Stimulation and Exercise for Taiwanese Pre-frail Older Adults
Frailty, Sleep Quality
Not yet recruiting
In-Person, Online, and Hybrid Healthy-Aging Education for Pre-Frailty and Frailty in Older Adults
Frailty, Pre-Frailty
Enrolling by invitation
Targeted Prehabilitation With Physical Exercise and Inspiratory Muscle Training for Elderly Frail Patients Prior to Ventral Hernia Repair
Frailty, Ventral Hernia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jui-Shan Lin, MD principal investigator

Tri-Service General Hospital (TSGH)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TCM Formula and HMB (beta-Hydroxy-beta-methylbutyrate) in people with Pre-Frailty and Sarcopenia, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Hand Grip Strength at Week 12 (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07597850, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.