TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age65+
SponsorTri-Service General Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
TCM Formula
DrugA 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 supplementThe 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.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: Experimental: TCM GroupExperimental treatment 1 intervention
Group B: Active Comparator: HMB GroupActive comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline and Week 12Secondary outcomes
1
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 24.2
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 24.3
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 24.4
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.Other outcomes
1
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 24.2
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 24Sponsors and contacts
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Tri-Service General Hospital
Lead sponsor
National Research Institute of Chinese Medicine, Ministry of Health and Welfare
Collaborator
Source ClinicalTrials.gov