UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054246 |
|---|---|
| Receipt number | R000061945 |
| Scientific Title | A study to confirm the effects of test food consumption on oral function and health in children |
| Date of disclosure of the study information | 2024/07/31 |
| Last modified on | 2024/11/12 09:17:47 |
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Basic information
Public title
A study to confirm the effects of test food consumption on oral function and health in children
Acronym
A study to confirm the effects of test food consumption on oral function and health in children
Scientific Title
A study to confirm the effects of test food consumption on oral function and health in children
Scientific Title:Acronym
A study to confirm the effects of test food consumption on oral function and health in children
Region
| Japan |
Condition
Condition
N/A
Classification by specialty
| Not applicable | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine the changes in oral function and health in children due to the consumption of the test food.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
oral function and health index
Key secondary outcomes
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
Oral ingestion of the test food 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
| 6 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Child
(1) Healthy male and female aged 6 to 12 years at the time point of acquiring the informed consent.
(2) Those who do not currently have dental care affecting their occlusion.
(3) Those who do not currently have braces.
(4) Those whose first molars have erupted.
(5) Those who are able to eat the test food once daily.
(6) Those who have received explanation and understood about this study, and who can consent to the content on the informed consent documents.
(7) Those who are judged by the investigator that they have no problem participating in the study.
Parent
(8) Parents of healthy male and female aged 6 to 12 years at the time point of acquiring the informed consent.
(9) Those who can cooperate with diary and questionnaire
(10) Those who have received explanation and understood about this study, and who can consent to the content on the informed consent documents.
Key exclusion criteria
(1) Those who have a history of medication, hospitalization, or surgery within a year.
(2) Those who have or suspected infectious disease such as COVID-19, or who are in close contact with such a disease on study entry.
(3) Those who are currently on any medical treatments, or who are planning some kind of treatments during the study period.
(4) Those who cannot eat chewing soft candy.
(5) Those who have allergy in medicine, foods. (Especially gelatin).
(6) Those who are unable to come to the hospital on the day of the examination.
(7) Those who have participated in other clinical trials within 3 months prior to the date of consent, are currently participating in a clinical trial of another drug or health food, or are scheduled to participate in another clinical trial after consent to participate in this trial.
(8) Those who judged by the principal investigator to be unsuitable for participation in the study.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Watanabe |
Organization
Morinaga & Co., Ltd.
Division name
R&D institute
Zip code
230-8504
Address
2-1-1, Shimosueyoshi, Tsurumi-ku, Yokohama
TEL
045-571-6140
h-watanabe-if@morinaga.co.jp
Public contact
Name of contact person
| 1st name | Itaru |
| Middle name | |
| Last name | Aoyama |
Organization
Morinaga & Co., Ltd.
Division name
R&D institute
Zip code
230-8504
Address
2-1-1, Shimosueyoshi, Tsurumi-ku, Yokohama
TEL
045-571-6140
Homepage URL
i-aoyama-af@morinaga.co.jp
Sponsor or person
Institute
Morinaga & Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Morinaga & 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
Japan Conference of Clinical Research
Address
1-13-23 Minamiikebukuro Toshima-ku Tokyo
Tel
03-6868-7022
jccr-info@jccr.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
| 2024 | Year | 07 | Month | 31 | 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
30
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 | 03 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 11 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 04 | Month | 24 | Day |
Last modified on
| 2024 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061945
