UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059050 |
|---|---|
| Receipt number | R000067539 |
| Scientific Title | Research on the functional and safety assessment of test food intake : Open-label study |
| Date of disclosure of the study information | 2025/09/17 |
| Last modified on | 2025/09/10 12:53:28 |
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Basic information
Public title
Research on the functional and safety assessment of test food intake
Acronym
Research on the functional and safety assessment of test food intake
Scientific Title
Research on the functional and safety assessment of test food intake
: Open-label study
Scientific Title:Acronym
Research on the functional and safety assessment of test food intake
: Open-label study
Region
| Japan |
Condition
Condition
Healthy elementary school student
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the effects and safety on immune function by continuously ingestion of test food for 8 weeks.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diary
Key secondary outcomes
Medical examination
s-IgA in saliva
Height measurement
Blood pressure
Inbody (weight, muscle mass)
Brief-type Diet History Questionnaire for 15-year-old
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 of test food for 8 consecutive 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
| 6 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Healthy elementary school students (1st to 6th grades: excluding menstrual periods)
(2) Subjects whose parents or legal guardians (hereinafter referred to as 'guardians') received a full explanation of the purpose and content of the study, fully understood it, and voluntarily provided written informed consent for the subject's participation in the study
Key exclusion criteria
(1) Subjects with a history of mental illness, diabetes, liver diseases, renal disease, gastrointestinal disease, cardiac disease, respiratory disease, peripheral vascular disease, or other serious disease.
(2) Subjects who have undergone gastrointestinal surgery.
(3) Subjects showing abnormal liver and kidney function test values.
(4) Subjects with a current medical condition. (excluding cavity treatment)
(5) Subjects who are allergic to food and drugs.
(6) Subjects who participate in strenuous sports and subjects who are trying to lose weight.
(7) Subjects with extremely irregular eating habits.
(8) Subjects who cannot stop taking health foods (including foods for specified health use and foods with functional claims) and quasi-drugs during the study period.
(9) Subjects who are continuously treated with medications (including OTC, prescription drugs).
(10) Subjects who are currently participating in other clinical studies or are scheduled to participate in research at the start of this study.
(11) Other subjects judged by the investigator or the investigator to be inappropriate for the examination.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yumi |
| Middle name | |
| Last name | Takeda |
Organization
Kewpie Corporation
Division name
R&D Division
Zip code
1820002
Address
2-5-7 Sengawacho, Chofu-shi, Tokyo
TEL
03-5384-7759
yumi_takeda@kewpie.co.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Terashima |
Organization
Oneness Support Co., Ltd.
Division name
Clinical Trial Division
Zip code
5300044
Address
Higashitenma building 6F, 1-7-17, Higashitenma, Kita-ku, Osaka
TEL
06-4801-8917
Homepage URL
mterashima@oneness-sup.co.jp
Sponsor or person
Institute
Miura Clinic, Medical Corporation Kanonkai
Institute
Department
Personal name
Funding Source
Organization
Kewpie Corporation
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 Committe of Miura Clinic, Medical Corporation Kanonkai
Address
Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka
Tel
06-6135-5200
mterashima@miura-cl.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
医療法人花音会みうらクリニック（大阪府）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 17 | 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 | 08 | Month | 28 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 18 | 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 | 09 | Month | 10 | Day |
Last modified on
| 2025 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067539
