UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059001 |
|---|---|
| Receipt number | R000067477 |
| Scientific Title | A study on the prebiotic effects of whole Jinenjo processed foods on gut microbiota |
| Date of disclosure of the study information | 2025/09/12 |
| Last modified on | 2025/09/12 14:31:14 |
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Basic information
Public title
Food monitor survey on whole Jinenjo Dango for improving the gut environment
Acronym
Food monitor survey on whole Jinenjo Dango for improving the gut environment
Scientific Title
A study on the prebiotic effects of whole Jinenjo processed foods on gut microbiota
Scientific Title:Acronym
A study on the prebiotic effects of whole Jinenjo processed foods on gut microbiota
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the improvement of the gut environment after 8 weeks of consuming processed foods made with whole Jinenjo.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in the gut microbiota before and after the intervention
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
Intake of test food for 8 weeks
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Subjects aged 18 to 65 as of April 1, 2025
2. Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the study and being able to personally sign a written informed consent
3. Subjects who have not taken any foods for specified health uses, functional foods, dietary supplements, that may affect defecation, or who can maintain the same type and frequency of intake of these products they have been taking up until that point during the study period
Key exclusion criteria
1.Subjects with serious cardio-vascular, hepatic, renal, respiratory, endocrine or metabolic disorders or having a medical history of these disorders
2.Subjects receiving treatment for a gastrointestinal disease currently or those who have had gastrointestinal surgery
3.Subjects with an allergy to the test food
4.Subjects who are suffering from or have a history of a disease that may affect defecation
5.Subjects who take regularly pharmaceuticals or quasi-drugs which having the efficacy for microbiome such as intestinal regulator
6.Subjects who have used antibiotics within the past month
7.Subjects who have had the habit of drinking vinegar (including fruit vinegar, black vinegar, etc.) continuously within the past 3 months
7.Subjects who plan to make significant changes to their lifestyle (e.g., diet, sleep, exercise) during the study period
8.Subjects with smoking habits
9.Subjects with high alcohol consumption (60g or more of pure alcohol per day)
10.Subjects with a frequency of fewer than three bowel movements per week
11.Subjects with irregular lifestyles due to night shifts
12.Female subjects who are pregnant or lactating, or intending to become pregnant during the study
13.Subjects who took part in another study within 3 months prior to the start of the present study or who is currently taking part in another study
14.Subjects deemed unsuitable by the investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Harada |
Organization
M-TEX Corporation
Division name
Representative Director
Zip code
742-0009
Address
2-32,Shin-ichi, Yanai,Yamaguchi
TEL
0820-22-0654
k-harada@m-tex.co.jp
Public contact
Name of contact person
| 1st name | Hisao |
| Middle name | |
| Last name | Nakatani |
Organization
Yamaguchi Health Lab.
Division name
General manager
Zip code
754-0041
Address
MEDIFIT LAB 3F, 1-1-2, Ogori Reiwa, Yamaguchi-City, Yamaguchi-Pref.
TEL
083-976-4095
Homepage URL
info@yamaguchi-hl.com
Sponsor or person
Institute
M-TEX Corporation
Institute
Department
Personal name
Funding Source
Organization
M-TEX Corporation
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
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku
Tel
03-5408-1599
shiba_palace@s-palace-clinic.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 | 09 | Month | 12 | 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
| 2025 | Year | 08 | Month | 14 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 12 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 10 | 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 | 09 | Month | 05 | Day |
Last modified on
| 2025 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067477
