UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059599 |
|---|---|
| Receipt number | R000068183 |
| Scientific Title | Study on Health, Intelligence, Nutrition, and Exercise, in Iwamizawa |
| Date of disclosure of the study information | 2025/11/05 |
| Last modified on | 2025/10/31 11:18:32 |
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Basic information
Public title
Study on Health, Intelligence, Nutrition, and Exercise, in Iwamizawa
Acronym
SHINE Iwamizawa
Scientific Title
Study on Health, Intelligence, Nutrition, and Exercise, in Iwamizawa
Scientific Title:Acronym
SHINE Iwamizawa
Region
| Japan |
Condition
Condition
Second-grade elementary school students
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the relationships among children's physical fitness, exercise habits, dietary habits, gut microbiome, daily lifestyle habits, and academic performance.
Basic objectives2
Others
Basic objectives -Others
Exploratory observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Learning proficiency and physical fitness
Key secondary outcomes
Gut microbiota and fecal substances
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 7 | years-old | <= |
Age-upper limit
| 9 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Second-grade students enrolled
2. Those whose guardians can give consent
Key exclusion criteria
Persons determined to be excluded by the principal investigator
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Noriteru |
| Middle name | |
| Last name | Morita |
Organization
Hokkaido University of Education, Iwamizawa, Japan.
Division name
Department of Sports Cultural Studies
Zip code
068-8642
Address
2-34-1 Midorigaoka, Iwamizawa-shi, Hokkaido, Japan
TEL
0126-32-0393
morita.noriteru@i.hokkyodai.ac.jp
Public contact
Name of contact person
| 1st name | Noriteru |
| Middle name | |
| Last name | Morita |
Organization
Hokkaido University of Education, Iwamizawa, Japan.
Division name
Department of Sports Cultural Studies
Zip code
068-8642
Address
2-34-1 Midorigaoka, Iwamizawa-shi, Hokkaido, Japan
TEL
0126-32-0393
Homepage URL
morita.noriteru@i.hokkyodai.ac.jp
Sponsor or person
Institute
Hokkaido University of Education
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hokkaido University Graduate School,
Morinaga Milk Industry Co., LTD.
Name of secondary funder(s)
Morinaga Milk Industry Co., LTD.
IRB Contact (For public release)
Organization
Hokkaido University of Education Research Ethics Committee
Address
5-3 Ainosato, Kita-ku, Sapporo, Hokkaido
Tel
011-778-0649
s-kenkyu@j.hokkyodai.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 05 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 08 | Month | 27 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 08 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this longitudinal study, we aim to elucidate the effects of the gut microbiome on physical fitness, academic performance, and lifestyle habits (such as exercise habits) among second-grade elementary school children in Hokkaido, Japan, through longitudinal investigation and analysis.
Management information
Registered date
| 2025 | Year | 10 | Month | 31 | Day |
Last modified on
| 2025 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068183
