UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045829
Receipt number R000052319
Scientific Title A study on task performance skill and e-sports performance by ingesting test foods.
Date of disclosure of the study information 2022/04/01
Last modified on 2022/06/24 15:31:45

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Basic information

Public title

A study on task performance skill and e-sports performance by ingesting test foods.

Acronym

A study on task performance skill and e-sports performance by ingesting test foods.

Scientific Title

A study on task performance skill and e-sports performance by ingesting test foods.

Scientific Title:Acronym

A study on task performance skill and e-sports performance by ingesting test foods.

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Concentration and performance of e-sports players were examining by consumption of commonly available test foods. The study contributes to improve of game performance and training efficiency a of e-sports players.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Task performance skill and performance indicators

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Single ingestion of test food- washout period- single ingestion of placebo food.

Interventions/Control_2

Single ingestion of placebo food- washout period- single ingestion of test food.

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


Not applicable

Gender

Male

Key inclusion criteria

(1) Subjects who have no underlying diseases and are in good health.
(2) Subjects who have received enough explanation and understood about this study, and who can obtain informed consent documents

Key exclusion criteria

(1) Subjects with health problems on the day of the experiment
(2)Subjects who intake excessive alcohol or caffeine.
(3)Subjects who have medicine, milk or gelatin allergy.
(4)Subjects who are planning some kind of treatment during the study period.
(5)Subjects who were judged ineligible for enrollment in the study by the principal investigator or sub-investigator.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Goichi
Middle name
Last name Hagiwara

Organization

Kyushu Sangyo University
Faculty of Human Sciences

Division name

Department of Sport Science and Health

Zip code

813-8503

Address

2-3-1 Matsukadai Higashi-ku Fukuoka

TEL

092-673-5501

Email

hagi-g@ip.kyusan-u.ac.jp


Public contact

Name of contact person

1st name Goichi
Middle name
Last name Hagiwara

Organization

Kyushu Sangyo University Faculty of Human Sciences

Division name

Department of Sport Science and Health

Zip code

813-8503

Address

2-3-1 Matsukadai Higashi-ku Fukuoka

TEL

092-673-5501

Homepage URL


Email

hagi-g@ip.kyusan-u.ac.jp


Sponsor or person

Institute

Kyushu Sangyo University
Faculty of Human Sciences,
Department of Sport Science and Health

Institute

Department

Personal name



Funding Source

Organization

Sankei Digital Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Nishinippon Institute of Technology
MORINAGA&CO.,LTD.

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kyushu Sangyo University Ethics Committee on Research Involving Human Subjects

Address

2-3-1 Matsukadai Higashi-ku Fukuoka

Tel

092-673-5488

Email

izumi@ip.kyusan-u.ac.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

九州産業大学 人間科学部 スポーツ健康科学科
西日本工業大学


Other administrative information

Date of disclosure of the study information

2022 Year 04 Month 01 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

20

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

No longer recruiting

Date of protocol fixation

2021 Year 04 Month 01 Day

Date of IRB

2021 Year 05 Month 20 Day

Anticipated trial start date

2021 Year 10 Month 01 Day

Last follow-up date

2021 Year 12 Month 31 Day

Date of closure to data entry

2022 Year 03 Month 01 Day

Date trial data considered complete

2022 Year 04 Month 01 Day

Date analysis concluded

2022 Year 04 Month 01 Day


Other

Other related information



Management information

Registered date

2021 Year 10 Month 22 Day

Last modified on

2022 Year 06 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052319