UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057437 |
|---|---|
| Receipt number | R000064653 |
| Scientific Title | Effects of Gum Chewing Training on Cognitive Function |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2025/03/28 16:40:45 |
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Basic information
Public title
Research on Mastication and Cognitive Function
Acronym
Research on Mastication and Cognitive Function
Scientific Title
Effects of Gum Chewing Training on Cognitive Function
Scientific Title:Acronym
Effects of Gum Chewing on Cognitive Function
Region
| Japan |
Condition
Condition
healthy older adults
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to determine the effects of gum chewing training on changes in cognitive function improvement through an open randomized parallel group study.
Basic objectives2
Others
Basic objectives -Others
Improvement of cognitive function
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
cognitive function
Key secondary outcomes
oral function, cognitive function, brain volume, resting state functional connectivity
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
chewing training with gum (3 times a day) and participation in lectures (once a month)
Interventions/Control_2
participation in lectures (once a month)
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Those who understand the purpose of this study and can consent to it.
2. Those who had masticatory function of 3 or higher (assessed by chewing gum).
3. Those who have at least 20 functional teeth.
4. Those who scored 24 or above on the MMSE-J
Key exclusion criteria
1. Those who have incomplete data
2. Those who have cerebrovascular disorder (including pre-existing)
3. Those who have been diagnosed with dementia
4. Those who have been diagnosed with depression
5. Those who cannot chew or eat gum
6. Those who use a cardiac pacemaker
7. Those who are contraindicated for MRI examinations due to the use of defi brillators, magnetic metal implants, etc.
8. Those who are participating in other intervention studies, or will be participating in such studies within 4 weeks
9. Those who are judged to be ineligible for the study by the dentists (principal investigators or research coordinators)
Target sample size
84
Research contact person
Name of lead principal investigator
| 1st name | Hirohiko |
| Middle name | |
| Last name | Hirano |
Organization
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Division name
Research Team for Promoting Independence and Mental Health
Zip code
173-0015
Address
35-2 Sakae-cho, Itabashi-ku, Tokyo
TEL
03-3964-1141
hhirano@tmig.or.jp
Public contact
Name of contact person
| 1st name | Maki |
| Middle name | |
| Last name | Shirobe |
Organization
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Division name
Research Team for Promoting Independence and Mental Health
Zip code
173-0015
Address
35-2 Sakae-cho, Itabashi-ku, Tokyo
TEL
03-3964-1141
Homepage URL
mshirobe@tmig.or.jp
Sponsor or person
Institute
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
LOTTE CO.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
LOTTE CO.,Ltd., Meiji University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tthe ethics committee of the Tokyo Metropolitan Institute for Geriatrics and Gerontology
Address
35-2 Sakae-cho, Itabashi-ku, Tokyo
Tel
03-3964-1141
rinsyoushiken@tmghig.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
| 2025 | Year | 04 | Month | 01 | 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 | 02 | Month | 05 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 05 | Day |
Anticipated trial start date
| 2025 | Year | 05 | 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
| 2025 | Year | 03 | Month | 28 | Day |
Last modified on
| 2025 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064653
