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

NCT ID: NCT07093190

Last Updated: 2025-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-18

Study Completion Date

2025-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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exercise following Rg1 consumption

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

Group Type EXPERIMENTAL

exercise following Rg1 consumption

Intervention Type DIETARY_SUPPLEMENT

The effect of Rg1 on exercised skeletal muscle in older women

exercise only following placebo consumption

Crossover trial with placebo supplementation consumed before exercise

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Resistance exercise performed 1 hour following placebo consumption

Interventions

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exercise following Rg1 consumption

The effect of Rg1 on exercised skeletal muscle in older women

Intervention Type DIETARY_SUPPLEMENT

Placebo

Resistance exercise performed 1 hour following placebo consumption

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Taipei

OTHER

Sponsor Role lead

Responsible Party

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Chia-Hua Kuo

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chia-hua Kuo, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Taipei

Locations

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University of Taipei

Taipei, Taipei, Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type BACKGROUND
PMID: 8266347 (View on PubMed)

Other Identifiers

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NSTC 110-2622-H-845-004

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

13A1-CG-CO-05-2426-3

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB-2021-045

Identifier Type: -

Identifier Source: org_study_id

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