UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049576 |
|---|---|
| Receipt number | R000056463 |
| Scientific Title | Search for blood biomarkers reflecting skeletal muscle fiber types |
| Date of disclosure of the study information | 2022/11/21 |
| Last modified on | 2024/05/14 15:43:32 |
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Basic information
Public title
Search for blood biomarkers reflecting skeletal muscle fiber types
Acronym
Search for blood biomarkers reflecting skeletal muscle fiber types
Scientific Title
Search for blood biomarkers reflecting skeletal muscle fiber types
Scientific Title:Acronym
Search for blood biomarkers reflecting skeletal muscle fiber types
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Search for blood biomarkers reflecting skeletal muscle fiber type and develop a non-invasive method of muscle fiber type identification
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Accuracy of blood biomarkers reflecting muscle fiber type
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Take blood samples, five times (five times of ten ml each collection)
Take muscle biopsy from leg, once
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 35 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy males whose age is between eighteen and thirty-five years old.
Healthy non-smoker males who is able to perform resistance exercise.
Healthy males with no dorastic lifestyle changes, such as dietary restrictions or strenuous exercise, during the experimental period.
Key exclusion criteria
Subjects whom investigators judge ineligible
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Akimoto |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1192
Address
2-579-15 Mikashima, Tokorozawa-shi, Saitama
TEL
04-2947-6848
axi@waseda.jp
Public contact
Name of contact person
| 1st name | Wataru |
| Middle name | |
| Last name | Emoto |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1192
Address
2-579-15 Mikashima, Tokorozawa-shi, Saitama
TEL
04-2947-6848
Homepage URL
emoto_wataru@fuji.waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Waseda University, Fuculty of Sport Sciences
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Management Division, Research Promotion Department, Waseda University
Address
1-104 Totsukacho, Shinjuku-ku, Tokyo
Tel
03-5272-4652
rps-management@list.waseda.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
早稲田大学所沢キャンパス（埼玉県）、多摩北整形外科病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 11 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 10 | Month | 27 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 26 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 30 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 11 | Month | 21 | Day |
Last modified on
| 2024 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056463
