UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062810 |
|---|---|
| Receipt number | R000071885 |
| Scientific Title | Study on the Association of Eating Efficiency with Oral Function and Salivary Bacterial Counts in Older Adults Requiring Long-term Care |
| Date of disclosure of the study information | 2026/09/03 |
| Last modified on | 2026/09/02 16:56:13 |
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Basic information
Public title
Study on the Association of Eating Efficiency with Oral Function and Salivary Bacterial Counts in Older Adults Requiring Long-term Care
Acronym
CARE-EAT Study
Scientific Title
Study on the Association of Eating Efficiency with Oral Function and Salivary Bacterial Counts in Older Adults Requiring Long-term Care
Scientific Title:Acronym
CARE-EAT Study
Region
| Japan |
Condition
Condition
Older adults requiring long-term care
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the associations of eating efficiency assessed using a simple sausage-based test with conventional oral function measures and salivary bacterial counts in older adults requiring long-term care, and to evaluate its potential usefulness as a simple screening indicator for aspiration pneumonia risk assessment.
Basic objectives2
Others
Basic objectives -Others
Assessment of the associations of eating efficiency with oral function and salivary bacterial counts
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Associations of sausage-based eating efficiency with oral function and salivary bacterial counts
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Aged 40 years or older
2.Individuals requiring long-term care who reside in facilities for older adults or persons with disabilities
3.Individuals who provide informed consent to participate in the study
Key exclusion criteria
1.Individuals with severe cognitive impairment that makes oral function testing difficult
2.Individuals with severe oral dryness that makes saliva collection difficult
3.Individuals with aspiration who are not receiving oral intake
4.Individuals with an allergy to any ingredient in the sausage
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Teruyuki |
| Middle name | |
| Last name | Niimi |
Organization
Aichi Gakuin University
Division name
Department of Oral and Maxillofacial Developmental Biology
Zip code
464-8651
Address
2-11 Suemoridori, Chikusa-ku, Nagoya
TEL
052-751-5835
niimi@dpc.agu.ac.jp
Public contact
Name of contact person
| 1st name | Teruyuki |
| Middle name | |
| Last name | Niimi |
Organization
Aichi Gakuin University
Division name
Division of Research and Treatment for Oral and Maxillofacial Congenital Anomalies
Zip code
464-8651
Address
2-11 Suemoridori, Chikusa-ku, Nagoya
TEL
052-751-7181
Homepage URL
niimi@dpc.agu.ac.jp
Sponsor or person
Institute
Aichi Gakuin University
Institute
Department
Personal name
Funding Source
Organization
Aichi Gakuin University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of the Japanese Society of Oral Care
Address
G-10E, 2-5 Hoo-cho, Chikusa-ku, Nagoya, Aichi,
Tel
052-784-5202
office@oralcare-jp.org
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 | 09 | 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 | 09 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 26 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 03 | 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
This is a prospective observational cross-sectional study in older adults requiring long-term care. Sausage-based eating efficiency, oral function including tongue pressure, maximum occlusal force, and masticatory efficiency, and salivary bacterial counts will be assessed, and the associations among these measures will be investigated. Salivary bacterial counts will be measured by real-time PCR using primers targeting the 16S rRNA gene. Associations of sausage-based eating efficiency and salivary bacterial counts with the assessed variables will be analyzed using the Mann-Whitney U test, Spearman's rank correlation coefficient, and multiple regression analysis.
Management information
Registered date
| 2026 | Year | 09 | Month | 03 | Day |
Last modified on
| 2026 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071885
