UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058783 |
|---|---|
| Receipt number | R000067167 |
| Scientific Title | Colonic fermentation characteristics of adzuki bean paste in vitro study using human fecal microbiota |
| Date of disclosure of the study information | 2025/08/13 |
| Last modified on | 2025/08/13 10:25:45 |
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Basic information
Public title
Study on the effect of adzuki bean paste on human colonic microbiota
Acronym
Colonic fermentation study of adzuki bean paste
Scientific Title
Colonic fermentation characteristics of adzuki bean paste in vitro study using human fecal microbiota
Scientific Title:Acronym
In vitro colonic fermentation study of adzuki bean paste
Region
| Japan |
Condition
Condition
Healthy individuals (adults)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of indigestible components of adzuki bean paste on the human colonic microbiota and fermentation metabolites in an in vitro system using human feces as an inoculum.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Both human feces and adzuki bean paste are cultured in an in vitro system, and the culture medium is collected after 0, 6, 12, 24, and 48 hours of incubation to analyze the microbial composition.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Men and women over 20 years old
2. Individuals who have not taken antibiotics in the two months prior to donation of fecal material.
3. Individuals who have received an explanation of the purpose and content of this study, understand it, and agree to participate in writing
Key exclusion criteria
Not applicable
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Kyu-Ho |
| Middle name | |
| Last name | Han |
Organization
Obihiro University of Agriculture and Veterinary Medicine
Division name
Department of Life and Food Sciences
Zip code
080-8555
Address
West 2-11, Inada, Obihiro, Hokkaido
TEL
0155495561
kyuho@obihiro.ac.jp
Public contact
Name of contact person
| 1st name | Ryuji |
| Middle name | |
| Last name | Nagata |
Organization
Obihiro University of Agriculture and Veterinary Medicine
Division name
Department of Life and Food Sciences
Zip code
080-8555
Address
West 2-11, Inada, Obihiro, Hokkaido
TEL
0155495419
Homepage URL
rnagata@obihiro.ac.jp
Sponsor or person
Institute
Obihiro University of Agriculture and Veterinary Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Pulse Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Obihiro University of Agriculture and Veterinary Medicine
Address
West 2-11, Inada, Obihiro, Hokkaido
Tel
0155495561
kyuho@obihiro.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 | 08 | Month | 13 | 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
4
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
In preparation for submission for publication
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
Completed
Date of protocol fixation
| 2022 | Year | 07 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study participants were asked to provide fecal material and no intervention was performed on it.
Management information
Registered date
| 2025 | Year | 08 | Month | 13 | Day |
Last modified on
| 2025 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067167
