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临床试验/NCT07703774
NCT07703774尚未招募不适用

Effect of Rg1-based Supplementation on Exercise Training-induced Stem Cell Recruitments and Skeletal Muscle Adaptation in Women Aged > 60

University of Taipei0 个研究点目标入组 60 人开始时间: 2026年8月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
主要终点
Bone marrow derived cells in skeletal muscle

研究概览

简要总结

This study will provide novel insights into the role of bone marrow-derived stem cells in muscle adaptation to long-term exercise and advance our understanding of an Rg-1 based supplement-Senactiv® as a potential intervention for preventing sarcopenia and cognitive decline in older adults.

详细描述

Background: We have recently observed increased mesenchymal stem cells (Stro-1+ MSCs) in exercised skeletal muscle in women > 60 years following consumption of a ginseng-derived Rg1-based supplement (Senactiv®). A substantial proportion of these mobilized stem cells differentiated into neural stem cells (Nestin+). Exercise-induced sex hormone depletion is completely attenuated. Together with our earlier finding that Senactiv® reduced perceived exertion during resistance exercise in young men, these results suggest that the supplement may enhance brain-muscle connection/rewiring to improve performance. This acute, single-dose study raises the important question of whether long-term Senactiv® consumption can augment muscle strength and mass in older women engaged in resistance training, a population at high risk of progressing into sarcopenia.

Study Design: To address this, we will conduct a 12-week, two-arm, randomized, double-blind, placebo-controlled trial. Primary and secondary outcomes will include muscle strength, perceived exertion, muscle mass, grip strength and sitting-rising test, sex hormones, Nestin+ neural stem cells, mitochondria-rich phagocytes (MPO-expressing cells), transcriptomic changes (RNA-seq) focusing on age-related biomarkers, bone marrow-derived cells and cognitive function. Skeletal muscle tissue will be analyzed using minimally invasive micro-biopsy at three time points: pre-exercise baseline, immediately after the first exercise bout (0 h, acute response), and 48 hours after the final training session (long-term adaptation). Cognitive function will be comprehensively assessed using available campus resources.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

Care providers will administer either the placebo or the treatment to participants without knowledge of the pill centent allocation. The placebo and treatment pills will be manufactured to be indistinguishable in appearance, ensuring blinding of both care providers and participants.

入排标准

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

入选标准

  • - Must be able to swallow pills

排除标准

  • Under anti-inflammatory medication.

研究组 & 干预措施

Placebo

Placebo Comparator

干预措施: Resistance exercise (Behavioral)

Senactiv

Experimental

Rg1-based supplement

干预措施: Resistance exercise (Behavioral)

结局指标

主要结局

Bone marrow derived cells in skeletal muscle

时间窗: * 3 weeks before exercise (baseline) * Immediately after exercise (0 hour) * 1-hour after exercise (1 h) * 24-hour after exercise (24 h)

Cell markers with bone marrow identity

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chia-Hua Kuo

Professor

University of Taipei

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