UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060397 |
|---|---|
| Receipt number | R000063313 |
| Scientific Title | Evaluation of the nutritional lunchbox on junior and senior highschool students attending private tutoring school. Cross-over test. |
| Date of disclosure of the study information | 2026/01/19 |
| Last modified on | 2026/01/18 13:01:46 |
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Basic information
Public title
Nutritinal luchbox trial at tutoring school.
Acronym
Nutritinal luchbox trial at tutoring school.
Scientific Title
Evaluation of the nutritional lunchbox on junior and senior highschool students attending private tutoring school. Cross-over test.
Scientific Title:Acronym
Evaluation of the nutritional lunchbox on junior and senior highschool students attending private tutoring school. Cross-over test.
Region
| Japan |
Condition
Condition
Japanese healthy junior and senior highschool students
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of a strong nutritional lunchbox on students' motivation to learn and fatigue through a human intervention study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective learning efficiency
Key secondary outcomes
Mental and physical complaints (fatigue, irritability, anxiety, somatic complaints)
Sleep quality
Mental and physical state during study
Stress during study
Skin condition
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Functional Lunch Boxes for 4 weeks, including 140g of sticky barley-rice, 230g of functional side dish and 2g of functional tea.
Interventions/Control_2
Regular meals daily taken for 4 weeks
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
| 12 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Healthy junior and senior highschool students who attend Tokushinkan Academy.
2. Junior and senior high schoolstudents who have a personal smartphone and can prepare a google account.
3. Students who fully understand the significance, content, and purpose of this examination, and who have given their consent in writing to participate in this examination.
Key exclusion criteria
1. Subjects who are under physicians advice, treatment, and/or medication for schizophrenia, depression, mania, neurological disorders, and/or sleep disorders.
2. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities.
3. Subjects with major surgical history relevant to the digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc.
4. Subjects with implantable electronic medical devices.
5. Subjects who are under nutritional advice by a physician.
6. Subjects who cannot continue to consume the test foods due to allergic reactions to drugs or foods.
7. Subjects who regularly use medicines (sleeping pills, psychotropic drugs, etc.) or health foods/supplements (glycine, gamma-aminobutyric acid, L-serine, L-theanine, L-ornithine, reduced coenzyme Q10, etc.) that affect stress and sleep.
8. Subjects with disordered lifestyle
9. Subjects who donated blood within 4 wks, prior to the current study.
10. Pregnant or lactating women or women who expect to be pregnant during this study.
11. Subjects who currently participate in other clinical trials or participated within the last 4 wks prior to the current study.
12. Subjects who have difficulty completing a full meal of the study food due to a small appetite.
13. Any other medical and/or health reasons unfavorable to participation in the current study, as judged by the principal investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Katsuhisa |
| Middle name | |
| Last name | Tanaka |
Organization
Flowing co. ltd.
Division name
Representative Director
Zip code
679-2162
Address
27-1, Noda, Kodera-cho, Himeji-city, Hyogo-prefecture, Japan
TEL
+81-79-232-6399
tanaka@flow-net.jp
Public contact
Name of contact person
| 1st name | Katsuhisa |
| Middle name | |
| Last name | Tanaka |
Organization
Flowing co. ltd.
Division name
Representative Director
Zip code
679-2162
Address
27-1, Noda, Kodera-cho, Himeji-city, Hyogo-prefecture, Japan
TEL
+81-79-232-6399
Homepage URL
uketuke@flow-net.jp
Sponsor or person
Institute
Flowing co. ltd.
Institute
Department
Personal name
Funding Source
Organization
Flowing co. ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NARO-Style Human Subjects Research Ethics Review Committee
Address
27-1, Noda, Kodera-cho, Himeji-city, Hyogo-prefecture, Japan
Tel
+81-79-232-6399
uketuke@flow-net.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
| 2026 | Year | 01 | Month | 19 | 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
46
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
Completed
Date of protocol fixation
| 2024 | Year | 05 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 21 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 01 | Month | 18 | Day |
Last modified on
| 2026 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000063313
