TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status (TCM-HMB-PF)
2026年5月13日 更新者：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.
調査の概要
状態
募集
詳細な説明
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.
研究の種類
介入
入学 (推定)
90
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Jui-Shan Lin, MD
- 電話番号：24260 886-2-87923311
- メール：sunnylin@mail.ndmutsgh.edu.tw
研究連絡先のバックアップ
- 名前：Li-Wei Wu, MD
- 電話番号：12618 886-2-87923311
- メール：liweiwu@mail.ndmutsgh.edu.tw
研究場所
-
-
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Taipei、台湾、114202
- 募集
- Tri-Service General Hospital
-
コンタクト：
- Jui-Shan Lin, MD
- 電話番号：24260 886-2-87923311
- メール：sunnylin@mail.ndmutsgh.edu.tw
-
主任研究者：
- Jui-Shan Lin, MD
-
副調査官：
- Li-Wei Wu, MD
-
副調査官：
- Sui-Lung Su, Prof.
-
副調査官：
- Wen-Hui Fang, MD
-
副調査官：
- Yaw-Wen Chang, MD
-
副調査官：
- Tung-Wei Kao, MD
-
副調査官：
- Hung-Yi Chen, MD
-
副調査官：
- Yan-Ru Wang, MD
-
副調査官：
- Yu-Heng Wang, MD
-
副調査官：
- Po-Han Lin, MD
-
副調査官：
- Tao-Chun Peng, MD
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副調査官：
- Ting-Ching Chen, MD
-
副調査官：
- Wan-Ting Soong, MD
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副調査官：
- Yu-Ting Cheng, MD
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副調査官：
- Yi-Ru Lei, MD
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
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.
他の名前：
|
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アクティブコンパレータ：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.
|
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.
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from Baseline in Hand Grip Strength at Week 12
時間枠：Baseline and Week 12
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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.
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Baseline and Week 12
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Hand Grip Strength at Week 24
時間枠：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.
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Baseline and Week 24.
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Change in Skeletal Muscle Mass
時間枠：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.
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Baseline, Week 12, and Week 24.
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Change in Calf Circumference
時間枠：Baseline, Week 12, and Week 24.
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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.
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Baseline, Week 12, and Week 24.
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Change in Gait Speed
時間枠：Baseline, Week 12, and Week 24.
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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.
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Baseline, Week 12, and Week 24.
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Change in Timed Up and Go (TUG) Test Time
時間枠：Baseline, Week 12, and Week 24.
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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.
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Baseline, Week 12, and Week 24.
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Change in Five Times Sit-to-Stand (5xSTS) Test Time
時間枠：Baseline, Week 12, and Week 24.
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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.
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Baseline, Week 12, and Week 24.
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Change in Fried Frailty Phenotype Status
時間枠：Baseline, Week 12, and Week 24.
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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.
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Baseline, Week 12, and Week 24.
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Change in Clinical Frailty Scale (CFS) Score
時間枠：Baseline, Week 12, and Week 24.
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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.
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Baseline, Week 12, and Week 24.
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Change in Bone Mineral Density (BMD)
時間枠：Baseline, Week 12, and Week 24.
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Change from baseline in bone mineral density measured by Dual-energy X-ray Absorptiometry (DXA, Lunar iDXA).
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Baseline, Week 12, and Week 24.
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Change in Body Fat Percentage
時間枠：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.
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Baseline, Week 12, and Week 24.
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Change in SF-12 Quality of Life Score
時間枠：Baseline, Week 12, and Week 24.
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Change from baseline in the 12-Item Short Form Health Survey (SF-12) scores.
Higher scores represent better health-related quality of life.
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Baseline, Week 12, and Week 24.
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of Treatment-Emergent Adverse Events (Safety)
時間枠：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).
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Baseline up to Week 24.
|
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Number of Participants With Clinically Significant Laboratory Abnormalities
時間枠：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) .
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Baseline up to Week 24
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Jui-Shan Lin, MD、Tri-Service General Hospital
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年4月2日
一次修了 (推定)
2026年10月31日
研究の完了 (推定)
2026年12月31日
試験登録日
最初に提出
2026年5月5日
QC基準を満たした最初の提出物
2026年5月13日
最初の投稿 (実際)
2026年5月19日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月19日
QC基準を満たした最後の更新が送信されました
2026年5月13日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- MBS-101
- 115-1-N001 (その他の助成金/資金番号：NRICM, MOHW)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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