UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056889 |
|---|---|
| Receipt number | R000064841 |
| Scientific Title | Association Between Food Intake and Gut Microbiota: A Retrospective Cohort Study in Japanese Adult Men and Women |
| Date of disclosure of the study information | 2025/02/04 |
| Last modified on | 2025/01/28 17:08:36 |
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Basic information
Public title
Study on the Association Between Food Intake and Gut Microbiota
Acronym
Study on the Association Between Food Intake and Gut Microbiota
Scientific Title
Association Between Food Intake and Gut Microbiota: A Retrospective Cohort Study in Japanese Adult Men and Women
Scientific Title:Acronym
Association Between Food Intake and Gut Microbiota: A Retrospective Cohort Study in Japanese Adult Men and Women
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the study is to clarify the relationship between the consumption of the specific food and the gut microbiota.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fluctuation in gut microbiota
Key secondary outcomes
frequency of bowel movements, stool characteristics, Questionnaire(diet, constitution, lifestyle habits, abdominal symptoms)
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Subjects who consume the specific food four or more days per week, or subjects whose consumption frequency of the specific food is one day or less per week.
Key exclusion criteria
Subjects
1.who have been diagnosed with gastrointestinal diseases, have undergone gastrointestinal surgery in the past, or expected to require gastrointestinal surgery in the future.
2.who are deemed unsuitable as participants based on their answers to the lifestyle questionnaire.
3.who have participated in other clinical studies within one month prior to obtaining consent to participate in this study, or who plan to participate in other clinical studies after obtaining consent to participate in this study.
4.who are deemed unsuitable as participants by the principal investigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Katsuhiro |
| Middle name | |
| Last name | Shiba |
Organization
Ina Food Industry Co.,Ltd.
Division name
Development Division
Zip code
399-4498
Address
5074 Nishi-haruchika, Ina City, Nagano, Japan
TEL
0265-78-1121
kshiba@kantenpp.co.jp
Public contact
Name of contact person
| 1st name | Ikuya |
| Middle name | |
| Last name | Shirai |
Organization
Ina Food Industry Co.,Ltd.
Division name
Development Division
Zip code
399-4498
Address
5074 Nishi-haruchika, Ina City, Nagano, Japan
TEL
0265-78-1121
Homepage URL
shirai-ikuya@kantenpp.co.jp
Sponsor or person
Institute
Ina Food Industry Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Cykinso, Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board
Address
1-14-26-204 Mihara-dai, Nerima-ku, Tokyo, Japan
Tel
080-7345-7947
info@okutoeru.com
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 | 02 | Month | 04 | 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
38
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 | 11 | Month | 29 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 30 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 16 | 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
This study is a retrospective cohort study examining the relationship between the consumption of specific foods and the gut microbiota.
Management information
Registered date
| 2025 | Year | 01 | Month | 31 | Day |
Last modified on
| 2025 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064841
