UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060035 |
|---|---|
| Receipt number | R000068637 |
| Scientific Title | Effects of Test Food Intake During Mental Work Tasks on Flow -Non-Blinded, Crossover Study- |
| Date of disclosure of the study information | 2025/12/10 |
| Last modified on | 2025/12/10 11:48:28 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of Test Food Intake During Mental Work Tasks on Flow
-Non-Blinded, Crossover Study-
Acronym
Effects of Test Food Intake During Mental Work Tasks on Flow
-Non-Blinded, Crossover Study-
Scientific Title
Effects of Test Food Intake During Mental Work Tasks on Flow
-Non-Blinded, Crossover Study-
Scientific Title:Acronym
Effects of Test Food Intake During Mental Work Tasks on Flow
-Non-Blinded, Crossover Study-
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A study will be conducted on healthy adult males to clarify the effects of the test food on flow states.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Subjective Evaluation
FLOW checklist
DJR
Key secondary outcomes
1)NASA-TLX
2)BJSQ
3)Numerical Search Tasks, Work Performance
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is 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
Main Test Phase I (Test Food) => Washout => Main Test Phase II (Control Food)
Interventions/Control_2
Main Test Phase I (Control Food) => Washout => Main Test Phase II (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
| 35 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Healthy White males aged 18 to 35 years at the time of informed consent
2) Individuals who are able to present health examination results conducted within the past year
3) Individuals without a habit of consuming test foods (3 cups or fewer per week)
4) Individuals who received a thorough explanation of the study's purpose and procedures, and signed the informed consent form prior to the start of the study
Key exclusion criteria
1) Individuals who are currently undergoing treatment for or have a history of malignant tumors, heart failure, or myocardial infarction
2) Individuals currently receiving treatment for the following chronic conditions:
Arrhythmia, liver dysfunction, kidney dysfunction, cerebrovascular disease, rheumatism, diabetes, dyslipidemia, hypertension, or other chronic diseases
3) Individuals receiving treatment for cardiovascular diseases such as arrhythmia
4) Individuals with severe symptoms of rhinitis
5) Individuals exhibiting symptoms of alcohol dependence or caffeine intoxication
6) Individuals who regularly medications (including herbal medicines), quasi-drugs, or supplements that may affect test parameters
7) Individuals who regularly consume Foods for Specified Health Uses (FOSHU), foods with functional claims, or other foods/beverages with potential functional properties that may affect test parameters
8) Individuals who has a smoking habit
9) Individuals experiencing physiological effects from water or Test food consumption (e.g., diarrhea, gastritis, stomach pain, etc.)
10) Individuals who are unable to understand English
11) Individuals who are unable to perform tests involving computer use following instructions in English
12) Individuals who do not agree to have the examination session recorded
13) Individuals who have participated in another clinical trial within 3 months prior to the date of consent acquisition, or who are scheduled to participate in another trial during the study period
14) Other individuals deemed unsuitable for participation in this trial by the principal investigator
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Kobayashi |
Organization
ITO EN, LTD.
Division name
Central Research Institute
Zip code
421-0516
Address
21 Mekami, Makinohara-shi, Shizuoka, Japan
TEL
0548-54-1247
m-kobayasi@itoen.co.jp
Public contact
Name of contact person
| 1st name | Masako |
| Middle name | |
| Last name | Mizuuchi |
Organization
APO PLUS STATION CO., LTD.
Division name
Clinical Operations Dept., CRO Business div.
Zip code
103-0027
Address
2-14-1, Nihonbashi, Chuo-ku, Tokyo 103-0027, Japan
TEL
03-6777-7789
Homepage URL
food-contact@apoplus.co.jp
Sponsor or person
Institute
APO PLUS STATION CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
ITO EN, 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
Ethics Review Committee of Watanabe Hospital
Address
1-5-16, Haneda, Otaku, Tokyo, 144-0043, Japan
Tel
03-3741-0223
food-contact@apoplus.co.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 | 12 | Month | 10 | 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 | 12 | Month | 03 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 03 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 11 | Day |
Last follow-up date
| 2026 | Year | 03 | 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 | 12 | Month | 10 | Day |
Last modified on
| 2025 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068637
