UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057418 |
|---|---|
| Receipt number | R000065601 |
| Scientific Title | Verification of health promotion effects of chewing on the elderly based on oral frailty prevention. |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2025/03/27 08:24:03 |
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Basic information
Public title
Verification of health promotion effects of chewing on the elderly based on oral frailty prevention.
Acronym
Verification of health promotion effects of chewing on the elderly based on oral frailty prevention.
Scientific Title
Verification of health promotion effects of chewing on the elderly based on oral frailty prevention.
Scientific Title:Acronym
Verification of health promotion effects of chewing on the elderly based on oral frailty prevention.
Region
| Japan |
Condition
Condition
Community-Dwelling Elderly
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examining how chewing affects the health of the elderly.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Bite force
Key secondary outcomes
Dental formula
Oral hygiene
Oral motor function
Tongue pressure
Chewing ability
Oral moisture
Oral frailty
Cognitive function (Moca-J)
Body composition (In body)
Grip strength
Walking speed
Standing on one leg with eyes open
Frail
Sarcopenia
Lifestyle questionnaire
Medical expenses data
Nursing care data
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Test food
Interventions/Control_2
No treatment
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) Men and women aged 65 or older who are citizens of Fujimi City
(2) Elderly people who can attend health checkups at the Health Promotion Center
(3) Those who can consent to providing medical and nursing care cost data
Key exclusion criteria
(1) Those who are extremely weak
(2) Those who are visiting the hospital due to an unstable illness
(3) Those who also have an acute illness, including an infectious disease
(4) Those who the researcher (dentist) judges to be unable to chew gum
(5) Those whose intervention implementation rate is below 70% and who have no intention of increasing the implementation rate at the time of follow-up
(6) Those who are otherwise deemed inappropriate by the principal investigator or co-researcher
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Hama |
Organization
Institute of Science Tokyo
Division name
Department of Gerodontology and Oral Rehabilitation, Graduate School of Medical and Dental Sciences
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5856
y.hama.gerd@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Hama |
Organization
Institute of Science Tokyo
Division name
Department of Gerodontology and Oral Rehabilitation, Graduate School of Medical and Dental Sciences
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5856
Homepage URL
y.hama.gerd@tmd.ac.jp
Sponsor or person
Institute
Lotte Co., Ltd.
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institute of Science Tokyo, Ethicala Review Committee
Address
1-5-45, Yushima, Bunkyo-Ku, Tokyo, 113-8519, Japan
Tel
03-5803-4547
rinri.adm@tmd.ac.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 | 01 | Month | 10 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 04 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 05 | Day |
Last follow-up date
| 2029 | 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 | 27 | Day |
Last modified on
| 2025 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065601
