- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07703774
Effect of Rg1-based Supplementation on Exercise Training-induced Stem Cell Recruitments and Skeletal Muscle Adaptation in Women Aged > 60 (Senactiv)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Chia-Hua Kuo, PhD
- Telefonnummer: +85263057921
- E-mail: kuochiahua@gmail.com
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Must be able to swallow pills
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Placebo komparator: Placebo
|
4 sets of 8-RM leg squats
|
|
Eksperimentel: Senactiv
Rg1-based supplement
|
4 sets of 8-RM leg squats
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Bone marrow derived cells in skeletal muscle
Tidsramme: * 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
|
* 3 weeks before exercise (baseline) * Immediately after exercise (0 hour) * 1-hour after exercise (1 h) * 24-hour after exercise (24 h)
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2025-2026-0067
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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