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

NCT07597850 | Recruiting Phase 2

• 2 other identifiers: MBS-101115-1-N001
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and Week 12

Secondary Outcomes (11)

• Change in Hand Grip Strength at Week 24

  Baseline and Week 24.

• Change in Skeletal Muscle Mass

  Baseline, Week 12, and Week 24.

• Change in Calf Circumference

  Baseline, Week 12, and Week 24.

• Change in Gait Speed

  Baseline, Week 12, and Week 24.

• Change in Timed Up and Go (TUG) Test Time

  Baseline, Week 12, and Week 24.

Other Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events (Safety)

  Baseline up to Week 24.

• Number of Participants With Clinically Significant Laboratory Abnormalities

  Baseline up to Week 24

Study Arms (2)

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.

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.

Dietary Supplement: HMB (beta-Hydroxy-beta-methylbutyrate)

Interventions

TCM Formula DRUG

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

Experimental: TCM Group

HMB (beta-Hydroxy-beta-methylbutyrate) DIETARY_SUPPLEMENT

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

Active Comparator: HMB Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Tri-Service General Hospital: lead
• National Research Institute of Chinese Medicine, Ministry of Health and Welfare: collaborator

Study Sites (1)

Tri-Service General Hospital

Taipei, 114202, Taiwan

RECRUITING

Related Publications (15)

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MeSH Terms

Conditions

Sarcopenia; Muscular Atrophy; Asthenia; Osteoporosis

Interventions

beta-hydroxyisovaleric acid

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Jui-Shan Lin, MD

  Tri-Service General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jui-Shan Lin, MD

CONTACT

886-2-87923311; sunnylin@mail.ndmutsgh.edu.tw

Li-Wei Wu, MD

CONTACT

886-2-87923311; liweiwu@mail.ndmutsgh.edu.tw

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study. Due to the distinct physical characteristics of the interventions (TCM vs. HMB nutritional supplement), masking of participants and investigators is not feasible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Model Details: Randomized, parallel-group, active-controlled study with a 1:1 allocation ratio.

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 19, 2026
• Study Start: April 2, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)