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

Sponsor
Tri-Service General Hospital
Study ID
NCT07597850
Phase
PHASE2
Status
Recruiting
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Conditions

  • Aging
  • Muscle Atrophy or Weakness
  • Osteoporosis
  • Pre-Frailty
  • Sarcopenia

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Apr 2, 2026
Status verified
May 2026
Primary completion
Oct 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental: TCM Group
    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.
  • Active Comparator: Active Comparator: HMB Group
    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.

Primary Outcome Measure

Change from Baseline in Hand Grip Strength at Week 12 [ Time Frame: Baseline and Week 12 ]

Central Contacts

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