UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056114 |
|---|---|
| Receipt number | R000064119 |
| Scientific Title | Study on the Effect of a Bento Rich in Dietary Fiber on Improving Gut Microbiota |
| Date of disclosure of the study information | 2024/11/11 |
| Last modified on | 2024/11/11 08:49:00 |
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Basic information
Public title
Study on the Effect of a Bento Rich in Dietary Fiber on Improving Gut Microbiota
Acronym
Study on the Effect of a Bento Rich in Dietary Fiber on Improving Gut Microbiota
Scientific Title
Study on the Effect of a Bento Rich in Dietary Fiber on Improving Gut Microbiota
Scientific Title:Acronym
Study on the Effect of a Bento Rich in Dietary Fiber on Improving Gut Microbiota
Region
| Japan |
Condition
Condition
Healthy Subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to propose a routine for improving gut health that can be easily incorporated into daily life. This study examines changes in the gut microbiota when consuming a Bento rich in dietary fiber five days a week (on weekdays only).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gut Microbiota
Self-Perception Survey(including defecation frequency)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
A bento containing an average of 7g of dietary fiber will be provided for lunch. The intervention period will last for 6 weeks, with bento provision on weekdays only.
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy faculty, staff, or graduate students (excluding undergraduates) commuting to the Hirakata Campus of Setsunan University.
Key exclusion criteria
Individuals who are likely unable to eat the Bento on weekdays or those currently undergoing treatment for any illness.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Inoue |
Organization
Setsunan University
Division name
Faculty of Agriculture
Zip code
573-0101
Address
45-1, Nagaotoge-cho, Hirakata, Oasaka
TEL
0728965469
ryo.inoue@setsunan.ac.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Inoue |
Organization
Setsunan University
Division name
Faculty of Agriculture
Zip code
573-0101
Address
45-1, Nagaotoge-cho, Hirakata, Oasaka
TEL
0728965469
Homepage URL
ryo.inoue@setsunan.ac.jp
Sponsor or person
Institute
Setsunan University
Institute
Department
Personal name
Funding Source
Organization
Primedica 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
Setsunan University
Address
17-8 Ikeda Nakamachi, Neyagawa City, Osaka
Tel
072-800-1160
SETSUNAN.Kenkyu.Shakai@josho.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
| 2024 | Year | 11 | 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
50
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
| 2024 | Year | 06 | Month | 11 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 11 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 09 | Day |
Last follow-up date
| 2025 | 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
| 2024 | Year | 11 | Month | 11 | Day |
Last modified on
| 2024 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064119
