UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017635 |
|---|---|
| Receipt number | R000020435 |
| Scientific Title | The effects of extreme diet towards brain function before and after matches in professional boxers |
| Date of disclosure of the study information | 2015/05/20 |
| Last modified on | 2021/05/31 14:18:54 |
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Basic information
Public title
The effects of extreme diet towards brain function before and after matches in professional boxers
Acronym
Brain before and after matches in professional boxers
Scientific Title
The effects of extreme diet towards brain function before and after matches in professional boxers
Scientific Title:Acronym
Brain before and after matches in professional boxers
Region
| Japan |
Condition
Condition
Healthy professional boxers
Classification by specialty
| Radiology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate the effects of professional boxer's extreme diet before and after the matches.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Brain imaging, Weight, Match
Key secondary outcomes
MRI
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| 45 | years-old | > |
Gender
Male
Key inclusion criteria
Professional boxers
Key exclusion criteria
Unhealthy
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yuichi |
| Middle name | |
| Last name | Ogino |
Organization
Gunma University
Division name
Anesthesiology
Zip code
371-8511
Address
Maebashi, Gunma
TEL
027-220-7111
oginoyuichi@me.com
Public contact
Name of contact person
| 1st name | Yuichi |
| Middle name | |
| Last name | Ogino |
Organization
Gunma University
Division name
Anesthesiology
Zip code
371-8511
Address
Maebashi, Gunma
TEL
027-220-7111
Homepage URL
http://anesthesiology.med.gunma-u.ac.jp
oginoyuichi@me.com
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
Gunma University
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Teikyo University
Name of secondary funder(s)
Radiology
IRB Contact (For public release)
Organization
Teikyo University
Address
2-11-1, Kaga, Itabashi, Tokyo
Tel
03-3964-1211
oginoyuichi@me.com
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
帝京大学附属病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 20 | 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
45
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
In submission.
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
Completed
Date of protocol fixation
| 2014 | Year | 12 | Month | 11 | Day |
Date of IRB
| 2014 | Year | 12 | Month | 11 | Day |
Anticipated trial start date
| 2015 | Year | 05 | Month | 21 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Published.
https://www.nature.com/articles/s41598-021-88368-4
Management information
Registered date
| 2015 | Year | 05 | Month | 20 | Day |
Last modified on
| 2021 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020435
