UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058201 |
|---|---|
| Receipt number | R000066535 |
| Scientific Title | Study on the prevention and improvement of frailty and malnutrition using prebiotics |
| Date of disclosure of the study information | 2025/06/17 |
| Last modified on | 2025/06/16 23:40:21 |
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Basic information
Public title
Study on the prevention and improvement of frailty and malnutrition using prebiotics
Acronym
Study on the prevention and improvement of frailty and malnutrition using prebiotics
Scientific Title
Study on the prevention and improvement of frailty and malnutrition using prebiotics
Scientific Title:Acronym
Study on the prevention and improvement of frailty and malnutrition using prebiotics
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine how prebiotic intake affects the pathogenesis of malnutrition and frailty through changes in intestinal bacteria
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Nutritional status, physical condition, intestinal microbiota, metabolome analysis, etc. at 6 weeks after consumption
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Prebiotic-containing beverage 100 g/day for 6 weeks
Interventions/Control_2
Prebiotic-free beverage 100 g/day for 6 weeks
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
None
Key exclusion criteria
Subjects deemed inappropriate as research participants by the principal investigator
(e.g., inability to collect specimens properly)
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Irie |
Organization
Okayama Prefectural University
Division name
Faculty of Health and Welfare Science
Zip code
719-1112
Address
111 Kuboki, Soja-shi, Okayama
TEL
0866-94-2111
yirie@fhw.oka-pu.ac.jp
Public contact
Name of contact person
| 1st name | Rikako |
| Middle name | |
| Last name | Inoue |
Organization
Okayama Prefectural University
Division name
Faculty of Health and Welfare Science
Zip code
719-1112
Address
111 Kuboki, Soja-shi, Okayama
TEL
0866-94-2111
Homepage URL
rinoue@fhw.oka-pu.ac.jp
Sponsor or person
Institute
Okayama Prefectural University
Institute
Department
Personal name
Funding Source
Organization
Meiji Holdings Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Meiji Holdings Co., Ltd.
Meiji Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama Prefectural University Ethics Committee
Address
111 Kuboki, Soja-shi, Okayama
Tel
0866-94-2111
kenkyu2@ad.oka-pu.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 | 06 | Month | 17 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 11 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 01 | 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 | 06 | Month | 16 | Day |
Last modified on
| 2025 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066535
