UMIN-CTR Clinical Trial

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
Email	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
Email	oginoyuichi@me.com

Sponsor
Institute	Gunma University
Institute
Department

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
Email	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	No longer recruiting
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	Seriatim Arising.

Management information
Registered date	2015 Year 05 Month 20 Day
Last modified on	2020 Year 11 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020435

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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