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Completed

NCT Number: NCT07093190

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

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.

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Key information

Age range

60 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Taipei

Taipei, 11153, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

exercise following Rg1 consumption

Dietary Supplement

The effect of Rg1 on exercised skeletal muscle in older women

Placebo

Dietary Supplement

Resistance exercise performed 1 hour following placebo consumption

Primary outcomes

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

    Time frame: from enrolment to the end of study at 8 weeks

    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.

  2. Nestin+ neural stem cell area in skeletal muscle biopsies

    Time frame: from enrolment to the end of study at 8 weeks

    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.

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

    Time frame: from enrolment to the end of study at 8 weeks

    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.

  4. Serum sex hormone levels 24 h following resistance exercise

    Time frame: from enrolment to the end of study at 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Taipei

Other

Registry information

Official study title

Effect of Rg1 Supplementation on Stem Cells in Exercised Skeletal Muscles of Women > 60 y

Important dates

Study start
2022
Primary completion
2022
Study completion
2025
First posted
Jul 30, 2025
Registry last updated
Jul 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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