UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061232 |
|---|---|
| Receipt number | R000070062 |
| Scientific Title | Gut microbiota mediates the association between aging and cognitive function: evidence from a population-based study linking diet, Bifidobacterium, and Mini-Mental State Examination (MMSE) score |
| Date of disclosure of the study information | 2026/04/11 |
| Last modified on | 2026/04/11 16:42:21 |
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Basic information
Public title
Gut microbiota mediates the association between aging and cognitive function: evidence from a population-based study linking diet, Bifidobacterium, and Mini-Mental State Examination (MMSE) score
Acronym
Research exploring the factors contributing to the decline of cognitive functions.
Scientific Title
Gut microbiota mediates the association between aging and cognitive function: evidence from a population-based study linking diet, Bifidobacterium, and Mini-Mental State Examination (MMSE) score
Scientific Title:Acronym
Mediation analysis among age, MMSE, and Bifidobacterium
Region
| Japan |
Condition
Condition
community-dwelling older adults
Classification by specialty
| Medicine in general | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the role of gut bacteria in cognitive decline.
Basic objectives2
Others
Basic objectives -Others
The relationship between gut bacteria and diet
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
To explore gut bacteria involved in age-related cognitive decline.
Key secondary outcomes
To clarify the relationship between gut bacteria and diet.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Local residents aged 65 and over who can cooperate
Key exclusion criteria
Nothing in particular.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Naito |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Human Immunology and Nutrition Science
Zip code
602-8566
Address
465 Kajii-cho, Kamigyo-ku, Kyoto 602-8566
TEL
075-251-5124
ynaito@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Naito |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Human Immunology and Nutrition Science
Zip code
602-8566
Address
465 Kajii-cho, Kamigyo-ku, Kyoto 602-8566
TEL
075-251-5124
Homepage URL
ynaito@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Yuji Naito
Funding Source
Organization
Others
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Prefectural University of Medicine
Address
465 Kajii-cho, Kamigyo-ku, Kyoto 602-8566
Tel
075-251-5505
ynaito@koto.kpu-m.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
| 2026 | Year | 04 | Month | 11 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2026 | Year | 04 | 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
578 local residents participated, and cognitive function testing using MMSE, gut microbiota analysis, and dietary surveys using BDHQ have been completed.
Management information
Registered date
| 2026 | Year | 04 | Month | 11 | Day |
Last modified on
| 2026 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070062
