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基于肠-肌-脑轴的山药丸对肌少症患者的形状调节机制

2026年9月1日 更新者：Zhizhen Liu、Fujian University of Traditional Chinese Medicine
少肌症主要表现为肌肉力量、质量和身体机能下降，并具有与认知、情绪问题重叠、变化或转化的特点，属于身心疾病范畴。 目前，该病的有效治疗方法和发病机制尚不清楚。 团队初步研究发现，经方山药丸在“脾主肌肉”方面具有独特的优势，可以显着提高小鼠的骨骼肌质量、力量和耐力。 肠-肌-脑轴-脾虚证可能是肌少症的关键发病机制。 由此，该研究提出一个假设：山药丸对肌少症患者的干预是否是通过肠道菌群调节的肌脑轴的双向通讯通路实现了机体的双向平衡调节。 该项目采用随机、安慰剂对照、双盲RCT研究设计，以肌肉减少症患者为研究对象，利用肌肉骨骼超声、肠道微生物群、非靶向代谢组学、功能性近红外成像等多学科技术。 探讨山药丸通过调节“肠-肌-脑轴”介导的肠道微生态和代谢相关分子来调节肌少症患者的作用机制。

研究概览

地位

主动，不招人

条件

干预/治疗

详细说明

这项随机、双盲、安慰剂对照研究拟招募 94 名合格的脾虚少肌症患者。 该试验将在中国福建省福建中医药大学附属第二人民医院进行。 所有受试者在入组前均需填写基线信息，以确定随机分组前患者的一般情况。 随后，受试者按 1:1 的比例随机分为两组：山药丸组（n = 47）和安慰剂组（n = 47），随机序列由未参与整个试验的统计专家提供。 其中山药丸是由山药、白术、人参组成的中药配方丸剂，安慰剂主要成分是玉米淀粉，与外观、形状、大小、颜色、规格、包装完全一致和山药丸的标签。 两组中药剂型均以丸+米汤给药形式（每日1次，7天/周，共24周）。 此外，为提高干预期间患者的依从性，要求两组患者每月参加一次健康教育讲座，干预后均随访24周。

比较干预前（第0周）、干预期间（第12周结束后）、干预结束时（第24周结束后）和随访期间的四个时间点（第 48 周结束后）。 主要指标为肌肉质量变化（24周减去基线），次要指标为肌力变化（握力；5次椅立测试）；身体机能（例如 6分钟步行测试、步态速度、起身时间测试）；通过问卷调查的形式对认知功能、生活质量及中医临床疗效进行调查，探讨山药丸对脾虚证患者的临床疗效。 其次，基于双任务，利用近红外光谱成像（fNIRS）探讨山药丸干预24周后临床疗效的改善是否与前额皮质和运动皮质脑区的血流动力学变化有关。运动认知。 随后，利用16S-rRNA测序和非靶向代谢组学探讨山药丸干预24周后临床疗效的改善是否与肠道菌群及其代谢物的调节有关，最终阐明肌脑串扰干预过程并探讨其潜在的作用机制。

研究类型

介入性

注册 (实际的)

192

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 中国
    • Fujian
      • Fuzhou、Fujian、中国、350003
        • The Second Affiliated Hospital of Fujian University of Traditional Chinese Medicine
      • Fuzhou、Fujian、中国、350003
        • Rehabilitation Hospital Affiliated to Fujian University of Traditional Chinese Medicine
    • Guangdong
      • Guangzhou、Guangdong、中国、510655
        • The Sixth Affiliated Hospital, Sun Yat-sen University

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

纳入标准：

  1. 年龄≥60岁，符合AWGS肌少症诊断标准，符合中医脾虚证辨证标准；
  2. 能够理解并配合试验，并自愿签署知情同意书。

排除标准：

  1. 严重神经系统疾病、肌肉骨骼系统疾病骨质疏松、严重骨关节炎引起的运动功能障碍；
  2. 严重的心脏、肺部或精神疾病，不受控制的内分泌或代谢疾病，或严重的肝肾功能（如肝硬化、肾结石病史、肾衰竭或透析病史）；
  3. 由于言语或未矫正的听力障碍而无法与研究者正常沟通；
  4. 严重认知障碍（简易精神状态检查：MMSE评分<24分），无法理解问卷和量表所包含的内容；
  5. 使用生长激素、雌激素、黄体酮或睾酮补充剂近3个月，或严重营养缺乏；
  6. 近三个月内参加过其他试验或中药补充试验。

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：三倍

武器和干预

参与者组/臂
干预/治疗
实验性的：Shanyu pill group
It consists of Chinese yam, Atractylodes macrocephala, and ginseng.
膳食补充剂：Shanyu pill
It consists of Chinese yam, Atractylodes macrocephala, and ginseng.
安慰剂比较：Placebo group
It consists of corn starch and dextrin
膳食补充剂：Placebo
It consists of corn starch and dextrin

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change From Baseline in Appendicular Skeletal Muscle Mass Index (ASMI)
大体时间：Baseline, Week 12, Week 24, and 2 years after completion of the 24-week intervention
Appendicular skeletal muscle mass (ASM) is assessed using dual-energy X-ray absorptiometry (DXA). ASM is calculated as the sum of lean soft tissue mass of the arms and legs. Appendicular skeletal muscle mass index (ASMI) is calculated as ASM divided by height squared (kg/m²). Changes in ASMI from baseline are assessed at week 12, week 24, and 2 years after completion of the 24-week intervention.The primary efficacy endpoint is the change in ASMI from baseline to week 24.
Baseline, Week 12, Week 24, and 2 years after completion of the 24-week intervention

次要结果测量

结果测量
措施说明
大体时间
Change From Baseline in Handgrip Strength
大体时间：Baseline, Week 12, Week 24, and 2 years after completion of the 24-week intervention
Handgrip strength is measured using a handgrip dynamometer and reported in kilograms (kg), with higher values indicating greater muscle strength.
Baseline, Week 12, Week 24, and 2 years after completion of the 24-week intervention
Change From Baseline in Five-Times Sit-to-Stand Test Performance
大体时间：Baseline, Week 12, Week 24, and 2 years after completion of the 24-week intervention
Lower-extremity functional strength is assessed using the five-times sit-to-stand test. Completion time is recorded in seconds, with a shorter completion time indicating better performance.
Baseline, Week 12, Week 24, and 2 years after completion of the 24-week intervention
Change From Baseline in Traditional Chinese Medicine Syndrome Score for Spleen Qi Deficiency
大体时间：Baseline, Week 12, Week 24, and 2 years after completion of the 24-week intervention
Traditional Chinese medicine syndrome severity is assessed using the Spleen Qi Deficiency Syndrome Score. The scale evaluates predefined signs and symptoms associated with spleen qi deficiency syndrome, and a total syndrome score is calculated according to the prespecified scoring criteria. Higher scores indicate greater severity of spleen qi deficiency syndrome.
Baseline, Week 12, Week 24, and 2 years after completion of the 24-week intervention
Change From Baseline in Gut Microbiota Composition
大体时间：Baseline, Week 24, and 2 years after completion of the 24-week intervention
Gut microbiota composition is assessed using 16S rRNA gene sequencing of fecal samples. Changes in microbial community structure are evaluated using measures of microbial diversity and the relative abundance of bacterial taxa to characterize intervention-related alterations in the gut microbiota.
Baseline, Week 24, and 2 years after completion of the 24-week intervention
Change From Baseline in Cortical Hemodynamic Responses Assessed by Functional Near-Infrared Spectroscopy
大体时间：Baseline, Week 24, and 2 years after completion of the 24-week intervention
Cortical hemodynamic responses are assessed using functional near-infrared spectroscopy (fNIRS) during motor-cognitive dual-task performance. Changes in cerebral oxygenation, including oxygenated hemoglobin responses in prefrontal and motor-related cortical regions, are evaluated to characterize intervention-related changes in cortical activation and brain functional responses.
Baseline, Week 24, and 2 years after completion of the 24-week intervention
Change From Baseline in Gait Speed
大体时间：Baseline, Week 12, Week 24, and 2 years after completion of the 24-week intervention.
Gait speed is measured in meters per second (m/s), with higher values indicating better walking performance.
Baseline, Week 12, Week 24, and 2 years after completion of the 24-week intervention.
Change From Baseline in 6-Minute Walk Distance
大体时间：Baseline, Week 12, Week 24, and 2 years after completion of the 24-week intervention.
Functional exercise capacity is assessed using the 6-minute walk test. The total distance walked is recorded in meters, with a longer distance indicating better exercise capacity.
Baseline, Week 12, Week 24, and 2 years after completion of the 24-week intervention.
Change From Baseline in Short Physical Performance Battery Score
大体时间：Baseline, Week 12, Week 24, and 2 years after completion of the 24-week intervention.
Physical performance is assessed using the Short Physical Performance Battery (SPPB). The total score ranges from 0 to 12, with higher scores indicating better lower-extremity physical performance.
Baseline, Week 12, Week 24, and 2 years after completion of the 24-week intervention.
Change From Baseline in Timed Up and Go Test Completion Time
大体时间：Baseline, Week 12, Week 24, and 2 years after completion of the 24-week intervention.
Mobility is assessed using the Timed Up and Go (TUG) test. Completion time is recorded in seconds, with a shorter completion time indicating better mobility.
Baseline, Week 12, Week 24, and 2 years after completion of the 24-week intervention.
Change From Baseline in Montreal Cognitive Assessment Score
大体时间：Baseline, Week 12, Week 24, and 2 years after completion of the 24-week intervention.
Global cognitive function is assessed using the Montreal Cognitive Assessment (MoCA). The total score ranges from 0 to 30, with higher scores indicating better global cognitive function.
Baseline, Week 12, Week 24, and 2 years after completion of the 24-week intervention.
Change From Baseline in Stroop Color-Word Test Completion Time
大体时间：Baseline, Week 12, Week 24, and 2 years after completion of the 24-week intervention.
Executive function and inhibitory control are assessed using the Stroop Color-Word Test. Completion time is recorded in seconds, with shorter completion time indicating better performance.
Baseline, Week 12, Week 24, and 2 years after completion of the 24-week intervention.
Change From Baseline in Stroop Color-Word Test Accuracy
大体时间：Baseline, Week 12, Week 24, and 2 years after completion of the 24-week intervention.
Executive function and inhibitory control are assessed using the Stroop Color-Word Test. Accuracy is calculated as the percentage of correct responses, with higher percentages indicating better performance.
Baseline, Week 12, Week 24, and 2 years after completion of the 24-week intervention.
Change From Baseline in Relative Abundance of Metabolites Detected by Untargeted Metabolomics
大体时间：Baseline, Week 24, and 2 years after completion of the 24-week intervention.
Untargeted metabolomics is performed on serum and fecal samples using liquid chromatography-mass spectrometry. Metabolite abundance is assessed semi-quantitatively based on LC-MS peak signals after XCMS preprocessing, internal-standard correction, and quality-control filtering. Changes from baseline are used to characterize intervention-related metabolic alterations.
Baseline, Week 24, and 2 years after completion of the 24-week intervention.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Fujian University of Traditional Chinese Medicine

调查人员

  • 首席研究员：Zhizhen Liu、Fujian University of Traditional Chinese Medicine

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2023年7月17日

初级完成 (实际的)

2024年12月10日

研究完成 (估计的)

2026年12月10日

研究注册日期

首次提交

2023年6月9日

首先提交符合 QC 标准的

2023年6月16日

首次发布 (实际的)

2023年6月26日

研究记录更新

最后更新发布 (实际的)

2026年9月4日

上次提交的符合 QC 标准的更新

2026年9月1日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • KFKT-2022-012

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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