UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057030 |
|---|---|
| Receipt number | R000065187 |
| Scientific Title | A cross-sectional study of the intestinal environment and frailty in older adults |
| Date of disclosure of the study information | 2025/12/31 |
| Last modified on | 2025/08/01 14:03:33 |
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Basic information
Public title
A cross-sectional study of the intestinal environment and frailty in older adults
Acronym
A cross-sectional study of the intestinal environment and frailty in older adults
Scientific Title
A cross-sectional study of the intestinal environment and frailty in older adults
Scientific Title:Acronym
A cross-sectional study of the intestinal environment and frailty in older adults
Region
| Japan |
Condition
Condition
Healthy older adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the relationship between the intestinal environment and frailty in older adults.
Basic objectives2
Others
Basic objectives -Others
Relevance
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Gut microbiota and parameters of intestinal barrier function
Key secondary outcomes
Frailty score, body composition, physical function, geriatric depression scale, cognitive function, inflammation, and oxidative stress
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. Subjects aged 65 years or older at the time of obtaining consent
2. Subjects who have been fully informed about the study and understand its contents, and who can sign a written informed consent
Key exclusion criteria
1. Subjects who are restricted from exercising by their physician or who cannot obtain consent from their physician to participate in this study
2. Subjects who have a history of major gastrointestinal surgery, such as gastrectomy, gastroenterostomy, or intestinal resection
3. Subjects who have participated in other clinical trials (except observational studies) within one month before obtaining consent to participate in this study
4. Subjects who are deemed inappropriate by the research director or physician to participate in this study
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Shuichi |
| Middle name | |
| Last name | Machida |
Organization
Juntendo University
Division name
Graduate School of Health and Sports Science
Zip code
270-1695
Address
1-1 Hiraka-gakuendai, Inzai, Chiba
TEL
0476-98-1001
machidas@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Shuichi |
| Middle name | |
| Last name | Machida |
Organization
Juntendo University
Division name
Graduate School of Health and Sports Science
Zip code
270-1695
Address
1-1 Hiraka-gakuendai, Inzai, Chiba
TEL
0476-98-1001
Homepage URL
machidas@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Meiji 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
Ethics Committee of the Faculty of Health and Sports Science, Juntendo University
Address
1-1 Hiraka-gakuendai, Inzai-shi, Chiba
Tel
0476-98-1001
sc-rinri@juntendo.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
順天堂大学（千葉県）/ Juntendo University (Chiba)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 31 | 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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 01 | Month | 09 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 09 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
It has been reported that the diversity of gut microbiota and intestinal barrier function decrease with aging, which affects muscle mass and muscle strength. In this study, we will conduct a case-control sampling of elderly subjects to clarify the relationship between gut environment and frailty.
Management information
Registered date
| 2025 | Year | 02 | Month | 14 | Day |
Last modified on
| 2025 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065187
