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

13. května 2026 aktualizováno: Jui-Shan Lin, MD, Tri-Service General Hospital

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.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

90

Fáze

  • Fáze 2

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

  • Tchaj-wan
      • Taipei, Tchaj-wan, 114202
        • Nábor
        • Tri-Service General Hospital
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Jui-Shan Lin, MD
        • Dílčí vyšetřovatel:
          • Li-Wei Wu, MD
        • Dílčí vyšetřovatel:
          • Sui-Lung Su, Prof.
        • Dílčí vyšetřovatel:
          • Wen-Hui Fang, MD
        • Dílčí vyšetřovatel:
          • Yaw-Wen Chang, MD
        • Dílčí vyšetřovatel:
          • Tung-Wei Kao, MD
        • Dílčí vyšetřovatel:
          • Hung-Yi Chen, MD
        • Dílčí vyšetřovatel:
          • Yan-Ru Wang, MD
        • Dílčí vyšetřovatel:
          • Yu-Heng Wang, MD
        • Dílčí vyšetřovatel:
          • Po-Han Lin, MD
        • Dílčí vyšetřovatel:
          • Tao-Chun Peng, MD
        • Dílčí vyšetřovatel:
          • Ting-Ching Chen, MD
        • Dílčí vyšetřovatel:
          • Wan-Ting Soong, MD
        • Dílčí vyšetřovatel:
          • Yu-Ting Cheng, MD
        • Dílčí vyšetřovatel:
          • Yi-Ru Lei, MD

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Lék: TCM Formula
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.
Ostatní jména:
  • TCM
Aktivní komparátor: 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.
Doplněk stravy: HMB (beta-Hydroxy-beta-methylbutyrate)
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.
Ostatní jména:
  • HMB

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change from Baseline in Hand Grip Strength at Week 12
Časové okno: 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.
Baseline and Week 12

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in Hand Grip Strength at Week 24
Časové okno: Baseline and 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.
Baseline and Week 24.
Change in Skeletal Muscle Mass
Časové okno: Baseline, Week 12, and Week 24.
Change from baseline in skeletal muscle mass measured by Bioelectrical Impedance Analysis (BIA). This reflects structural changes in muscle quantity.
Baseline, Week 12, and Week 24.
Change in Calf Circumference
Časové okno: Baseline, Week 12, and Week 24.
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.
Baseline, Week 12, and Week 24.
Change in Gait Speed
Časové okno: Baseline, Week 12, and Week 24.
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.
Baseline, Week 12, and Week 24.
Change in Timed Up and Go (TUG) Test Time
Časové okno: Baseline, Week 12, and Week 24.
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.
Baseline, Week 12, and Week 24.
Change in Five Times Sit-to-Stand (5xSTS) Test Time
Časové okno: Baseline, Week 12, and Week 24.
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.
Baseline, Week 12, and Week 24.
Change in Fried Frailty Phenotype Status
Časové okno: Baseline, Week 12, and Week 24.
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.
Baseline, Week 12, and Week 24.
Change in Clinical Frailty Scale (CFS) Score
Časové okno: Baseline, Week 12, and Week 24.
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.
Baseline, Week 12, and Week 24.
Change in Bone Mineral Density (BMD)
Časové okno: Baseline, Week 12, and Week 24.
Change from baseline in bone mineral density measured by Dual-energy X-ray Absorptiometry (DXA, Lunar iDXA).
Baseline, Week 12, and Week 24.
Change in Body Fat Percentage
Časové okno: Baseline, Week 12, and Week 24.
Change from baseline in body fat percentage analyzed using DXA (Lunar iDXA). This reflects changes in body composition related to metabolic health.
Baseline, Week 12, and Week 24.
Change in SF-12 Quality of Life Score
Časové okno: Baseline, Week 12, and Week 24.
Change from baseline in the 12-Item Short Form Health Survey (SF-12) scores. Higher scores represent better health-related quality of life.
Baseline, Week 12, and Week 24.

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Incidence of Treatment-Emergent Adverse Events (Safety)
Časové okno: Baseline up to Week 24.
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).
Baseline up to Week 24.
Number of Participants With Clinically Significant Laboratory Abnormalities
Časové okno: Baseline up to Week 24
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) .
Baseline up to Week 24

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Tri-Service General Hospital

Spolupracovníci

National Research Institute of Chinese Medicine, Ministry of Health and Welfare

Vyšetřovatelé

  • Vrchní vyšetřovatel: Jui-Shan Lin, MD, Tri-Service General Hospital

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

2. dubna 2026

Primární dokončení (Odhadovaný)

31. října 2026

Dokončení studie (Odhadovaný)

31. prosince 2026

Termíny zápisu do studia

První předloženo

5. května 2026

První předloženo, které splnilo kritéria kontroly kvality

13. května 2026

První zveřejněno (Aktuální)

19. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

19. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

13. května 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • MBS-101
  • 115-1-N001 (Jiné číslo grantu/financování: NRICM, MOHW)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

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.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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