- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07569627
Effects of BFR-training on Stem Cells and Immune Cells in Human Skeletal Muscle
Study Overview
Status
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Taiwan
-
Taipei, Taiwan, Taiwan, 111
- Laboratory of Exercise Biochemistry
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- healthy men
Exclusion Criteria:
- inflammatory or immune conditions
Study Plan
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 |
Intervention / Treatment |
|---|---|
|
Sham Comparator: Sham (20 mmHg)
Study 1: Sham: blood flow restriction (20 mmHg on leg) for 3-5 min before exercise |
Sprinting exercise after BFR
Other Names:
|
|
Experimental: BFR (180 mmHg)
Study 1: BFR: blood flow restriction (180 mmHg on leg) for 3-5 min before exercise |
Sprinting exercise after BFR
Other Names:
|
|
Placebo Comparator: Placebo-BFR exercise
Study 2: Placebo (cornstarch)-ingestion before and after BFR-exercise |
NMN ingested before and after BFR exercise
Other Names:
|
|
Experimental: NMN-BFR exercise
Study 2: NMN-ingestion before and after BFR-exercise |
NMN ingested before and after BFR exercise
Other Names:
|
|
Placebo Comparator: Placebo-resistance exercise
Study 3: Cornstarch-ingestion before and after resistance exercise |
Vitamin C ingested before and after resistance exercise
Other Names:
|
|
Experimental: Vitamin C-resistance exercise
Study 3: Vitamin C-ingestion before and after BFR-exercise |
Vitamin C ingested before and after resistance exercise
Other Names:
|
What is the study measuring?
Primary Outcome Measures
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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