UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048217 |
|---|---|
| Receipt number | R000054943 |
| Scientific Title | A exploratory study of the effect of yogurt intake on the health condition of elementary school students and school staff |
| Date of disclosure of the study information | 2022/11/30 |
| Last modified on | 2023/01/10 11:09:57 |
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Basic information
Public title
A exploratory study of the effect of yogurt intake on the health condition of elementary school students and school staff
Acronym
A exploratory study of the effect of yogurt intake on the health condition
Scientific Title
A exploratory study of the effect of yogurt intake on the health condition of elementary school students and school staff
Scientific Title:Acronym
A exploratory study of the effect of yogurt intake on the health condition
Region
| Japan |
Condition
Condition
Adult and child
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the effect of continuous intake of yogurt by elementary school students and school staff on the onset cold symptoms and health condition
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of absences due to cold symptoms
Key secondary outcomes
Cold symptoms (frequency and days)
Questionnaire of health condition
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of yogurt on school day for 4 weeks
Interventions/Control_2
Non-intake of yogurt on school day 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
School students
(1) Elementary school studends
(2) Students whose parent or guardian can understand the purpose and the contents of this study, and is willing to provide consent as student's proxy
(3) Students who is willing to provide informed ascent
School staff
(1) School staff over 18 years old
(2) School staff who can understand the purpose and the contents of this study, and are willing to provide consent
Key exclusion criteria
Subjects who intake yogurt
(1) Subjects with allergy or lactose in tolerance
(2) Subjects with phenylketonuria
Subjects who don't intake yogurt
None
Target sample size
1900
Research contact person
Name of lead principal investigator
| 1st name | Toshihiro |
| Middle name | |
| Last name | Sashihara |
Organization
Meiji Co., Ltd
Division name
Food microbiology and Function Research Laboratories
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachioji, Tokyo 192-0919, Japan
TEL
042-632-5842
toshihiro.sashihara@meiji.com
Public contact
Name of contact person
| 1st name | Yuka |
| Middle name | |
| Last name | Katsukura |
Organization
Meiji Co., Ltd
Division name
Food microbiology and Function Research Laboratories
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachioji, Tokyo 192-0919, Japan
TEL
042-632-5842
Homepage URL
yuka.katsukura@meiji.com
Sponsor or person
Institute
Meiji Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Meiji 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
Meiji Institutional Review Board
Address
1-29-1 Nanakuni, Hachioji, Tokyo 192-0919, Japan
Tel
042-632-5900
MEIJI.IRB@meiji.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
| 2022 | Year | 11 | Month | 30 | 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
1838
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
| 2022 | Year | 05 | Month | 23 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 12 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 06 | Month | 30 | Day |
Last modified on
| 2023 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054943
