UMIN-CTR Clinical Trial

Basic information
Public title	Effects of functional food intake and playing esports on physical condition
Acronym	Effects of functional food intake and playing esports on physical condition
Scientific Title	Effects of functional food intake and playing esports on physical condition
Scientific Title:Acronym	Effects of functional food intake and playing esports on physical condition
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluate the effect of functional food intake and esports
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Esports score Stress marker
Key secondary outcomes	Questionnaire Blood oxygen saturations Pulse

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	Intake a test food- washout- intake a placebo food
Interventions/Control_2	Intake a placebo food- washout- intake a 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	18 years-old <=
Age-upper limit	60 years-old >
Gender	Male and Female
Key inclusion criteria	Healthy people playing esports
Key exclusion criteria	1)Regularly use excessive alcohol and tobacco 2)Extremely irregular diet 3)Taking ingest foods for specified health use, foods with functional claims, and other foods and beverages with possible functionalities 4)Willing to become pregnant during pregnancy, breastfeeding, or during the study period 5)Participated in other clinical trials or plan to participate during this research period 6)Diagnosed with some kind of illness and are being treated or taking medication 7)Serious illness 8)Persons who will not be judged suitable to the participants by the investigator
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Atsushi Middle name Last name Taga
Organization	Kindai University
Division name	Faculty of Pharmacy
Zip code	577-0818
Address	3-4-1, Kowakae, Higashi-osaka, Osaka
TEL	06-4307-4005
Email	punk@phar.kindai.ac.jp

Public contact
Name of contact person	1st name Rina Middle name Last name Kato
Organization	UHA Mikakuto Co., Ltd.
Division name	Global Healthcare Research Laboratory
Zip code	5400016
Address	4-12, Kanzaki-cho, Osaka-shi, Osaka
TEL	06-6767-6050
Homepage URL
Email	katour@uha-mikakuto.co.jp

Sponsor
Institute	Kindai University
Institute
Department

Funding Source
Organization	UHA Mikakuto Co.,Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kindai University
Address	3-4-1, Kowakae, Higashi-osaka, Osaka
Tel	06-6721-2332
Email	nakayama@phar.kindai.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	近畿大学 (大阪府)　Kindai University, Osaka

Other administrative information
Date of disclosure of the study information	2023 Year 08 Month 23 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	Preinitiation
Date of protocol fixation	2022 Year 08 Month 22 Day
Date of IRB	2022 Year 04 Month 16 Day
Anticipated trial start date	2022 Year 08 Month 22 Day
Last follow-up date	2022 Year 12 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 08 Month 22 Day
Last modified on	2022 Year 08 Month 22 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055513