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Not yet recruiting NCT07703774

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

No phase Interventional Myeloid Cell Infiltration

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Resistance exercise.
Who it may be relevant to
Registry conditions: Myeloid Cell Infiltration. Basic parameters: 20 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Detailed description

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.

Interventions

  • Behavioral Resistance exercise
    4 sets of 8-RM leg squats

Primary outcome measures

  • Bone marrow derived cells in skeletal muscle [Time frame: * 3 weeks before exercise (baseline) * Immediately after exercise (0 hour) * 1-hour after exercise (1 h) * 24-hour after exercise (24 h)]

Eligibility criteria

Inclusion criteria

\- Must be able to swallow pills

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Basic science

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07703774 · 2025-2026-0067

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗