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临床试验/NCT07309120
NCT07309120已完成不适用

Nutrition Ameliorates the Muscle Loss of Pre-sarcopenia in Elderly

Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年12月24日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Appendicular Skeletal Muscle Index (ASMI)

研究概览

简要总结

This study evaluates the effects of a 12-week leucine-enriched protein supplementation in adults aged 60 years and more. Participants will undergo assessments of muscle mass and function, as well as metabolic profiles in blood, urine, and feces before and after the intervention.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
60 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Willing to provide written informed consent.
  • Participants who attend health check-ups at Songshan District, Taipei City, or at the Wellness Cultural Village, or who have participated in the pilot study.
  • Adults aged 60 years or older, male or female.
  • Able to ambulate independently.
  • Meets at least one of the following sarcopenia criteria:
  • Grip strength: Men < 28 kg; Women < 18 kg Gait speed: < 1.0 m/s Muscle mass (appendicular skeletal muscle mass / height²): Men < 7.0 kg/m²; Women < 5.7 kg/m²

排除标准

  • Impaired renal function.
  • Allergy or intolerance to protein supplements.
  • Currently undergoing cancer treatment.
  • Autoimmune diseases.
  • Assessed by a physician as unsuitable to participate.

研究组 & 干预措施

Protein Supplementation Group

Experimental

干预措施: Participants consume two sachets daily over a 12-week intervention period. (Dietary Supplement)

结局指标

主要结局

Appendicular Skeletal Muscle Index (ASMI)

时间窗: Baseline and 12 weeks after intervention

Muscle mass was assessed using bioelectrical impedance analysis (Tanita MC-780MA). The appendicular skeletal muscle index (ASMI, kg/m2) was calculated as appendicular skeletal muscle mass (ASM, kg) divided by height squared (m²).

Handgrip Strength (HGS)

时间窗: Baseline and 12 weeks after intervention

Functional performance was evaluated by handgrip strength (HGS, kg), measured with a digital hand dynamometer.

Gait speed (m/s)

时间窗: Baseline and 12 weeks after intervention

Gait speed was assessed as the time required to walk a 4 meters, expressed in meters per second (m/s).

次要结局

未报告次要终点

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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