UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058786 |
|---|---|
| Receipt number | R000067222 |
| Scientific Title | Evaluation research on the effects of test food intake on children's intestinal health, lifestyle habits (emotions and stress), and learning |
| Date of disclosure of the study information | 2025/08/13 |
| Last modified on | 2025/08/13 13:42:02 |
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Basic information
Public title
Evaluation research on the effects of test food intake on children's intestinal health, lifestyle habits (emotions and stress), and learning
Acronym
Evaluation research on the effects of test food intake on children's intestinal health, lifestyle habits (emotions and stress), and learning
Scientific Title
Evaluation research on the effects of test food intake on children's intestinal health, lifestyle habits (emotions and stress), and learning
Scientific Title:Acronym
Evaluation research on the effects of test food intake on children's intestinal health, lifestyle habits (emotions and stress), and learning
Region
| Japan |
Condition
Condition
Healthy person
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine whether kestose-containing foods are actually effective in improving the intestinal environment, lifestyle habits (emotions and stress), and learning outcomes for healthy male and female parents and children attending cram schools who are concerned about their stomach conditions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bowel movements based on a questionnaire about stomach condition (frequency of bowel movements, stool characteristics, etc.)
Key secondary outcomes
Mood and lifestyle questionnaire, learning effect
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake 3 g (Adults) or 2 g (children) of test food every day for 4 weeks.
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
| 2 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Persons who are aged 2 to 75 at the time of consent, both men and women
2. Persons who are not suffering from intestinal diseases (including those who are judged not to require immediate treatment)
3. Persons who received a sufficient explanation of the purpose and contents of the research, have the capacity to consent by themselves or by legal representatives
Key exclusion criteria
1. Persons who are under the age of 18 and cannot obtain parental consent
2. Persons who may experience abdominal pain when eating ingredients containing oligosaccharides such as kestose
3. Persons who have been diagnosed with a digestive disease, previously undergone digestive surgery, and will require digestive surgery in the future
4. Persons who regularly use (at least 3 days a week) ingredients containing oligosaccharides such as kestose, or have regularly used within the 3 months prior to the pre-test
5. Persons who have been diagnosed with malignant tumors, currently receiving treatment for cranial nerve, heart, kidney, diabetes, or thyroid dysfunction, and with a history of serious illnesses such as liver disease, excluding illnesses like hypertension, which the principal investigator determined will not affect the evaluation of the research.
6. Persons who drink a large amount of alcohol (60 g or more of alcohol per day: approximately 1500 mL of beer, 540 mL of wine, 3 cups of sake, or 180 mL of double-sized whiskey)
7. Persons who are at risk of developing allergies related to the test foods
8. Persons who are judged unsuitable as research subjects based on their responses to a background survey
9. Persons who have participated in other research during one month prior to the start of this research, or plan to participate in other research after consenting to this research.
10. Persons who are judged to be ineligible by the principal investigator
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Masato |
| Middle name | |
| Last name | Shiomitsu |
Organization
Hama Gakuen Co., Ltd.
Division name
President's office
Zip code
662-0832
Address
1-5-24 Kofuuen, Nishinomiya, Hyogo, Japan
TEL
0798-64-1199
m-shiomitsu@hamagakuen.co.jp
Public contact
Name of contact person
| 1st name | Takumi |
| Middle name | |
| Last name | Tochio |
Organization
BIOSIS Lab. Co., Ltd.
Division name
CEO
Zip code
470-1101
Address
Room 506, Building No. 11, 1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, JAPAN
TEL
090-6904-6772
Homepage URL
takumitochiobiz@gmail.com
Sponsor or person
Institute
Hama Gakuen Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Hama Gakuen 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
The Ethics Committee
Address
1-18-26-204 Miharadai, Nerima-ku, Tokyo
Tel
080-7345-7947
info@okutoeru.com
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 | 08 | Month | 13 | 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
101
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 | 10 | Month | 12 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 12 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 13 | 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 | 08 | Month | 13 | Day |
Last modified on
| 2025 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067222
