UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063336 |
|---|---|
| Receipt number | R000072480 |
| Scientific Title | A Cross-Sectional Study of Nutrition and Gut Microbiota Among Nursing Home Residents |
| Date of disclosure of the study information | 2026/10/28 |
| Last modified on | 2026/10/19 11:18:15 |
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Basic information
Public title
A Study of Nutrition and Gut Microbiota Among Nursing Home Residents
Acronym
A Study of Nutrition and Gut Microbiota Among Nursing Home Residents
Scientific Title
A Cross-Sectional Study of Nutrition and Gut Microbiota Among Nursing Home Residents
Scientific Title:Acronym
A Cross-Sectional Study of Nutrition and Gut Microbiota Among Nursing Home Residents
Region
| Japan |
Condition
Condition
Residents of Nursing Homes
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the nutritional status, gut microbiota, and physical function of nursing home residents.
Basic objectives2
Others
Basic objectives -Others
Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood test parameters (hematological tests, blood biochemical tests, and metabolomic analyses), dietary intake, bowel habits (frequency, stool consistency, and stool odor), gut microbiota, body composition, history of falls, activities of daily living (ADL), oral condition (OHAT), and long-term care services received.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Aged 65 years or older at the time of informed consent
2. Residents of a nursing home
Key exclusion criteria
1. Hospitalization and medical treatment within the past month
2. Planned hospitalization within the next month
3. Suspected infectious disease within the past 2 weeks
4. Current participation in another clinical trial
5. Judged by the principal investigator or sub-investigators to be unsuitable for participation in this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Hidaka |
Organization
SENSTYLE Co., Ltd.
Division name
Research Department
Zip code
862-0911
Address
1-37-6 Kengun, Higashi-ku, Kumamoto City, Kumamoto, Japan
TEL
096-234-6661
j.hidaka@senstyle.co.jp
Public contact
Name of contact person
| 1st name | Shuto |
| Middle name | |
| Last name | Higuchi |
Organization
SENSTYLE Co., Ltd.
Division name
Research Department
Zip code
862-0911
Address
1-37-6 Kengun, Higashi-ku, Kumamoto City, Kumamoto, Japan
TEL
096-234-6661
Homepage URL
laboratory@senstyle.co.jp
Sponsor or person
Institute
SENSTYLE Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry 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
Institutional Review Board of the Institute of Geriatric Behavioral Science, SENSTYLE Co., Ltd.
Address
1-37-6 Kengun, Higashi-ku, Kumamoto City, Kumamoto, Japan
Tel
096-234-6661
laboratory@senstyle.co.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 | 10 | Month | 28 | 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 | 10 | Month | 09 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 28 | 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
1.Research design
Observational study
2.Outcomes
Blood test parameters (hematological tests, blood biochemical tests, and metabolomic analyses), dietary intake, bowel habits (frequency, stool consistency, and stool odor), gut microbiota composition, body composition, fall history, activities of daily living (ADL), oral condition (OHAT), and long-term care services received.
Management information
Registered date
| 2026 | Year | 10 | Month | 19 | Day |
Last modified on
| 2026 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072480
