Stem Cell Recruitment in Exercised Skeletal Muscles of Older Women by Phytosteroid Rg1

NCT07093190 | Completed

• 3 other identifiers: IRB-2021-045NSTC 110-2622-H-845-00413A1-CG-CO-05-2426-3
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this interventional study is to observe the effects of bone marrow stem cell behavior in skeletal muscle of women between 60 to 75 years old after a single moderate resistance exercise session. Plant sterol Rg1, a compound known to enhance stem cell infiltration following exercise in young men will be tested against a placebo in a double blinded crossover design. The main questions to be answered are:

• Does Rg1 supplementation alter serum sex hormone levels in recovery from exercise?
• Does Rg1 supplementation influence bone marrow stem cell differentiation in skeletal muscles of older women? Participants will:
• Pre-test body composition, maximal leg strength, blood and muscle tissue.
• One hour after taking the supplement, participants will perform 4 sets of 10 repetitions of 70% of maximal strength (1RM) leg press and have two thigh muscle biopsies (0 and 24 h after exercise).
• Repeat the protocol one month later on the alternative supplement. Researchers will understand whether Rg1 improves recovery response to resistance exercise in post-menopausal women.

Conditions

Exercise Training; Post-menopausal Women; Bone Marrow Stem Cells; Skeletal Muscle Recovery

Outcome Measures

Primary Outcomes (4)

• Stro-1+ bone marrow stem cell area in skeletal muscle biopsies

  Immunofluorescence staining will be used to semi-quantitatively analyze Stro-1+ BMSC presence in skeletal muscle of older women before, 0h and 24h after a moderate resistance exercise session.

  from enrolment to the end of study at 8 weeks

• Nestin+ neural stem cell area in skeletal muscle biopsies

  Immunofluorescence staining will be used to semi-quantitatively analyze Nestin+ neural stem cell presence in skeletal muscle of older women before, 0h and 24h after a moderate resistance exercise session.

  from enrolment to the end of study at 8 weeks

• CD34+/CD31+ vascular stem cell area in skeletal muscle biopsies

  Immunofluorescence staining will be used to semi-quantitatively analyzeCD34+/CD31+ vascular stem cell presence in skeletal muscle of older women before, 0h and 24h after a moderate resistance exercise session.

  from enrolment to the end of study at 8 weeks

• Serum sex hormone levels 24 h following resistance exercise

  Forearm blood draw and Elisa analysis of serum for estradiol, progesterone, and testosterone of older women before and 24h after a moderate resistance exercise session.

  from enrolment to the end of study at 8 weeks

Study Arms (2)

exercise following Rg1 consumption

EXPERIMENTAL

1 hour following the consumption of the Rg1 supplement, participants performed exercise intervention before muscle biopsies were taken.

Dietary Supplement: exercise following Rg1 consumption

exercise only following placebo consumption

PLACEBO COMPARATOR

Crossover trial with placebo supplementation consumed before exercise

Dietary Supplement: Placebo

Interventions

exercise following Rg1 consumption DIETARY_SUPPLEMENT

The effect of Rg1 on exercised skeletal muscle in older women

exercise following Rg1 consumption

Placebo DIETARY_SUPPLEMENT

Resistance exercise performed 1 hour following placebo consumption

exercise only following placebo consumption

Eligibility Criteria

• Age: 60 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• sedentary, able to cease medications and supplements for 48 h before and 24 h after exercise session, medically sound for lower body moderate resistance exercise

You may not qualify if:

• use of insulin, sex hormone and immune-modulating medications, smoking and regular alcohol consumption

Sponsors & Collaborators

• University of Taipei: lead

Study Sites (1)

University of Taipei

Taipei, Taipei, 11153, Taiwan

Location

Related Publications (1)

• Glaziou P, Martin PM. Study of factors that influence the clinical response to ciguatera fish poisoning. Toxicon. 1993 Sep;31(9):1151-4. doi: 10.1016/0041-0101(93)90130-b.

  PMID: 8266347 BACKGROUND

Study Officials

• Chia-hua Kuo, PhD

  University of Taipei

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: July 30, 2025
• Study Start: March 18, 2022
• Primary Completion: December 2, 2022
• Study Completion: July 1, 2025
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

TW (1)