UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062359 |
|---|---|
| Receipt number | R000071346 |
| Scientific Title | Food Intake Training for Working-Age Adults |
| Date of disclosure of the study information | 2026/08/03 |
| Last modified on | 2026/07/28 11:31:30 |
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Basic information
Public title
Food Intake Training for Working-Age Adults
Acronym
Food Intake Training for Working-Age Adults
Scientific Title
Food Intake Training for Working-Age Adults
Scientific Title:Acronym
Food Intake Training for Working-Age Adults
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effects of Food Intake Training on Physical and Oral Health in Working-Age Adults
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oral Health, Physical Health, Cognitive Function, Questionnaire
Key secondary outcomes
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
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Test food
Interventions/Control_2
No intake
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Subjects giving written informed consent
(2) Individuals with no oral health issues regarding the consumption of test foods
(3) Individuals capable of participating in the training
Key exclusion criteria
(1) Participants who withdrew their consent to participate in the trial for reasons unrelated to the trial itself, but due to their own personal circumstances
(2) Participants who experienced a serious adverse event, and for whom the principal investigator or co-investigator determined that the trial should be discontinued
(3) Participants for whom the principal investigator or co-investigator determined that continuing the trial was unfeasible based on subjective or objective symptoms
(4) Participants for whom it was determined after the start of the trial that they did not meet the eligibility criteria
(5) Participants who do not follow the instructions of the principal investigator, sub-investigator, or other designated personnel
(6) Other participants for whom the principal investigator or sub-investigator determined that trial participation should be discontinued
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kazuto |
| Middle name | |
| Last name | Okabayashi |
Organization
Lotte Co., Ltd.
Division name
Research and Development Center, Kamukoto Research Department
Zip code
336-8601
Address
1-1, Numakage-3chome, Minami-ku, Saitama
TEL
048-837-0744
okabayashi_kazuto@lotte.co.jp
Public contact
Name of contact person
| 1st name | N/A |
| Middle name | |
| Last name | N/A |
Organization
Yachiyo City Dental Association
Division name
Yachiyo Dental Association Oral Care Center
Zip code
276-0042
Address
2-10 Yurinokidai, Yachiyo-shi, Chiba
TEL
047-485-7535
Homepage URL
none@example.com
Sponsor or person
Institute
Lotte Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
LOTTE Co., Lte
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Yachiyo City Dental Association
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiba Palace Clinic
Address
6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
Tel
03-5408-1590
jimukyoku@mail.souken-r.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
| 2026 | Year | 08 | Month | 03 | 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
| 2026 | Year | 06 | Month | 18 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 09 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | 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
| 2026 | Year | 07 | Month | 28 | Day |
Last modified on
| 2026 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071346
