Effects of BFR-training on Stem Cells and Immune Cells in Human Skeletal Muscle

July 9, 2026 updated by: Chia-Hua Kuo, University of Taipei
In this 3-year project, investigators will first measure stem cells (primary outcome) and immune cells (secondary outcome) in human skeletal muscle immediately after and 24 hour after the BFR-training. In the second and third year, the effect of β-NMN (vitamin B3 precursor) and antioxidant on the same outcomes after BFR-exercise will be assessed. The BFR-exercise in the study will consist of a 5 × 10-second sprinting with maximal voluntary efforts, 5 minutes after a BFR pre-conditioning to legs using pressurized cuffs. In Study 1 (1st year, N = 24, aged 20-30 year), a randomized crossover trial will be conducted to compare the efficacy of sprinting exercise using BFR pre-conditioning at 20 mmHg (control) or 180 mmHg (occlusion). Study 2 (2nd year, N = 24, aged 20-30 years) will be conducted to examine the effect of β-NMN supplementation on the aforementioned outcomes in human muscles using a randomized placebo-controlled crossover study design. Study 3 (third year, N = 24, aged 20-30 years) will be conducted to examine the effect of vitamin C on the same variables immediately after and 24 hours after resistance exercise intervention, using a randomized placebo-controlled crossover study design.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Primary outcome: Stem cells (Stro-1+ cells) assessed by immunofluorescence staining.

Secondary outcome: Immune cells (MPO+ cells) assessed by immunofluorescence staining.

Study 1: Two-arm intervention (counterbalanced crossover design): Sham-exercise, BFR-exercise Study 2: Two-arm intervention (counterbalanced crossover design): Placebo-BFR exercise, NMN-BFR exercise Study 3: Two-arm intervention (counterbalanced crossover design): Placebo-BFR exercise, Vitamin C-BFR exercise

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Taiwan
      • Taipei, Taiwan, Taiwan, 111
        • Laboratory of Exercise Biochemistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • healthy men

Exclusion Criteria:

  • inflammatory or immune conditions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Sham Comparator: Sham (20 mmHg)

Study 1:

Sham: blood flow restriction (20 mmHg on leg) for 3-5 min before exercise
Behavioral: BFR (180 mmHg)
Sprinting exercise after BFR
Other Names:
  • Sham (20 mmHg)
Experimental: BFR (180 mmHg)

Study 1:

BFR: blood flow restriction (180 mmHg on leg) for 3-5 min before exercise
Behavioral: BFR (180 mmHg)
Sprinting exercise after BFR
Other Names:
  • Sham (20 mmHg)
Placebo Comparator: Placebo-BFR exercise

Study 2:

Placebo (cornstarch)-ingestion before and after BFR-exercise
Dietary supplement: NMN-BFR exercise
NMN ingested before and after BFR exercise
Other Names:
  • Placebo-BFR exercise
Experimental: NMN-BFR exercise

Study 2:

NMN-ingestion before and after BFR-exercise
Dietary supplement: NMN-BFR exercise
NMN ingested before and after BFR exercise
Other Names:
  • Placebo-BFR exercise
Placebo Comparator: Placebo-resistance exercise

Study 3:

Cornstarch-ingestion before and after resistance exercise
Dietary supplement: Vitamin C-resistance exercise
Vitamin C ingested before and after resistance exercise
Other Names:
  • Placebo-resistance exercise
Experimental: Vitamin C-resistance exercise

Study 3:

Vitamin C-ingestion before and after BFR-exercise
Dietary supplement: Vitamin C-resistance exercise
Vitamin C ingested before and after resistance exercise
Other Names:
  • Placebo-resistance exercise

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Stem cells in muscle
Time Frame: Pre-exercise, immediately post-exercise, and 24-hour post-challenge (BFR-exercise) recovery
Stem cells are identified by Stro-1 cell marker
Pre-exercise, immediately post-exercise, and 24-hour post-challenge (BFR-exercise) recovery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Immune cells in muscle
Time Frame: At 24-hour post-challenge recovery
Immune cells are identified by myeloperoxidase (MPO) cell marker
At 24-hour post-challenge recovery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Taipei

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 7, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB-2021-082
  • MOST 111-2410-H-845 -005 -MY3 (Other Grant/Funding Number: National Science and Technology Council)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings