Exercise TrainingNCT07093190
Stem Cell Recruitment in Exercised Skeletal Muscles of Older Women by Phytosteroid Rg1
A study testing exercise following Rg1 consumption in people with Exercise Training and Post-menopausal Women, run by University of Taipei at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Exercise Training, Post-menopausal Women, Bone Marrow Stem Cells
- What is being tested?
- exercise following Rg1 consumption
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteTaiwan
- Study dates
- 18 Mar 2022to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- use of insulin, sex hormone and immune-modulating medications, smoking and regular alcohol consumption
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Rg1 Supplementation on Stem Cells in Exercised Skeletal Muscles of Women > 60 y
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:
Read more
- 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
- Being tested
- exercise following Rg1 consumption, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise following Rg1 consumptionDietary supplement
The effect of Rg1 on exercised skeletal muscle in older women
PlaceboDietary supplement
Resistance exercise performed 1 hour following placebo consumption
| Study group | Role | What they receive |
|---|---|---|
| exercise following Rg1 consumption | Experimental | 1 hour following the consumption of the Rg1 supplement, participants performed exercise intervention before muscle biopsies were taken. Receives: Dietary Supplement: exercise following Rg1 consumption |
| exercise only following placebo consumption | Placebo comparator | Crossover trial with placebo supplementation consumed before exercise Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: from enrolment to the end of study at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start18 Mar 2022
- Primary completion2 Dec 2022
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Exercise TrainingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Taipei
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chia-Hua Kuo, University of Taipei
- Investigators
- Chia-hua Kuo, PhD, Principal investigator, University of Taipei
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07093190
- Sponsor's protocol ID
- IRB-2021-045
- Other IDs
- NSTC 110-2622-H-845-004, 13A1-CG-CO-05-2426-3
- Status last verified
- Jul 2025
- First submitted
- 21 Jul 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The National Research Institutes of Health (Taiwan) will conduct gene analysis on remaining muscle samples for aiding understanding of sarcopenia
Publications
Lee TXY, Wu J, Jean WH, Condello G, Alkhatib A, Hsieh CC, Hsieh YW, Huang CY, Kuo CH. Reduced stem cell aging in exercised human skeletal muscle is enhanced by ginsenoside Rg1. Aging (Albany NY). 2021 Jun 28;13(12):16567-16576. doi: 10.18632/aging.203176. Epub 2021 Jun 28.
PubMed 34181580
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Rg1 Supplementation on Stem Cells in Exercised Skeletal Muscles of Women > 60 y
- ClinicalTrials.gov ID
- NCT07093190
- Acronym / sponsor ID
- IRB-2021-045
- Conditions
- Exercise Training, Post-menopausal Women, Bone Marrow Stem Cells, Skeletal Muscle Recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of TaipeiUniversity, hospital or other
- Study start
- 18 Mar 2022 (actual)
- Primary completion
- 2 Dec 2022 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 30 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exercise following Rg1 consumption | Experimental | Dietary Supplement: exercise following Rg1 consumption1 hour following the consumption of the Rg1 supplement, participants performed exercise intervention before muscle biopsies were taken. |
| exercise only following placebo consumption | Placebo comparator | Dietary Supplement: PlaceboCrossover trial with placebo supplementation consumed before exercise |
Who may qualify
- Ages
- 60 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- use of insulin, sex hormone and immune-modulating medications, smoking and regular alcohol consumption
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercise following Rg1 consumptionThe effect of Rg1 on exercised skeletal muscle in older women | Dietary supplement | exercise following Rg1 consumption |
| PlaceboResistance exercise performed 1 hour following placebo consumption | Dietary supplement | exercise only following placebo consumption |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Background: PubMed 34181580Lee TXY, Wu J, Jean WH, Condello G, Alkhatib A, Hsieh CC, Hsieh YW, Huang CY, Kuo CH. Reduced stem cell aging in exercised human skeletal muscle is enhanced by ginsenoside Rg1. Aging (Albany NY). 2021 Jun 28;13(12):16567-16576. doi: 10.18632/aging.203176. Epub 2021 Jun 28.
- Individual participant dataSharing planned: Yes. The National Research Institutes of Health (Taiwan) will conduct gene analysis on remaining muscle samples for aiding understanding of sarcopenia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chia-hua Kuo, PhD principal investigator
University of Taipei
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise following Rg1 consumption in people with Exercise Training and Post-menopausal Women, run by University of Taipei at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stro-1+ bone marrow stem cell area in skeletal muscle biopsies (time frame: from enrolment to the end of study at 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07093190, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.