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

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 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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name