UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059833 |
|---|---|
| Receipt number | R000068425 |
| Scientific Title | Examination of the effects of test food intake on objective and subjective flow states. - A randomized, double-blind, placebo-controlled, crossover study- |
| Date of disclosure of the study information | 2025/11/20 |
| Last modified on | 2025/11/20 14:21:47 |
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Basic information
Public title
Examination of the effects of test food intake on objective and subjective flow states.
Acronym
Examination of the effects of test food intake on objective and subjective flow states.
Scientific Title
Examination of the effects of test food intake on objective and subjective flow states. - A randomized, double-blind, placebo-controlled, crossover study-
Scientific Title:Acronym
Examination of the effects of test food intake on objective and subjective flow states.
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effects of a single dose of test food on objective and subjective flow states and game performance during game play in healthy adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
EEG (SMR-wave)
Key secondary outcomes
EEG (alpha-wave, beta-wave)
Flow Short Scale
Scores associated with game
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
A single administration of the test food is performed. After a washout period, a single administration of placebo is performed.
Interventions/Control_2
A single administration of the placebo is performed. After a washout period, a single administration of test food is performed.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
a. healthy men and woman aged 18 years or older at the time of consent.
b. people who regularly play games.
c. people who have received a full explanation of the purpose and content of the study, are competent to consent, fully understand the content, and voluntarily volunteer to participate in the study and provide written consent.
Key exclusion criteria
a. taking medication or under medical treatment
b. under exercise therapy or dietetic therapy
c. allergic to test food
d. current dependence or history of either medicine or alcohol dependence syndrome
e. current or prior diagnosis of mental illness (depression) or sleep disturbance
f. on a night-shift or shift worker
g. extremely irregular lifestyle
h. unbalanced diet
i. current or past history of serious illnesses such as diabetes, liver disease (hepatitis), kidney disease, heart disease, thyroid disease, adrenal gland disease, or other metabolic disorders.
j. excessive amounts of energy drinks.
k. participation in other clinical studies within the past 3 months from the day of consent or planning to participate in other clinical studies during the current study.
l. pregnant, lactating, or intending to become pregnant during the study period
m. deemed unsuitable as subjects based on EEG measurements during SCR.
n. considered as an inappropriate candidate by the doctor in charge.
Target sample size
11
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Yamashita |
Organization
Pharma Foods International Co., Ltd.
Division name
Research and Development
Zip code
6158245
Address
1-49, Goryo-ohara, nishikyo-ku, Kyoto city, Kyoto, Japan.
TEL
0757489829
y-yamashita@pharmafoods.co.jp
Public contact
Name of contact person
| 1st name | Ryosuke |
| Middle name | |
| Last name | Furukado |
Organization
NISHINIPPON INSUTITUTE OF TECHNOLOGY
Division name
Faculty of Engineering
Zip code
8000344
Address
1-11 Aratsu Kanda-machi Miyako-gun Fukuoka Japan
TEL
0930-23-1491
Homepage URL
furukado@nishitech.ac.jp
Sponsor or person
Institute
Pharma Foods International Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Pharma Foods International Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Yg R&D Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Corporation Taihukukai, Tokyo Shinjuku Clinic Ethics Review Committee
Address
SIL Shinjuku Building 5F, 2-46-3 Kabukicho, Shinjuku-ku, Tokyo
Tel
03-6709-6071
irb@ml.taifukukai.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | 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
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
| 2025 | Year | 11 | Month | 13 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 14 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2025 | 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
| 2025 | Year | 11 | Month | 20 | Day |
Last modified on
| 2025 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068425
