UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059138 |
|---|---|
| Receipt number | R000067370 |
| Scientific Title | Evaluation of the effects of test food intake on improving the gut environment |
| Date of disclosure of the study information | 2025/09/19 |
| Last modified on | 2025/09/19 18:02:00 |
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Basic information
Public title
Evaluation of the effects of test food intake on improving the gut environment
Acronym
Evaluation of the effects of test food intake on improving the gut environment
Scientific Title
Evaluation of the effects of test food intake on improving the gut environment
Scientific Title:Acronym
Evaluation of the effects of test food intake on improving the gut environment
Region
| Japan |
Condition
Condition
Healthy male/female adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is to exploratorily evaluate the effects of ingesting the test food for 4 weeks on the gut environment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gut Microbiota
Key secondary outcomes
Gut metabolites
Defecation status (including bowel movement frequency, number of days with bowel movements, stool volume, stool consistency, stool color, sensation of incomplete evacuation, abdominal pain during defecation, and odor)
Abdominal symptoms between bowel movements (including bloating, borborygmus, and gas)
Laboratory parameters
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Group A: Consume 10 test foods per day
Interventions/Control_2
Group B: Consume 2 test foods per day
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Male and female subjects, aged 20 to 64 years inclusive, at the time of informed consent.
(2) Subjects with a bowel movement frequency of 3 to 5 times per week.
(3) Subjects who have received a full explanation of the study, are capable of understanding the procedures, and have voluntarily provided written informed consent.
Key exclusion criteria
(1) Unable to comply with study dietary restrictions as specified in the "Prohibited/Restricted Food List".
(2) Current, recent (within 4 weeks), or planned participation in another clinical trial.
(3) Highly irregular lifestyle (e.g., night or rotating shifts).
(4) Extremely irregular dietary habits.
(5) Excessive alcohol consumption.
(6) Current smoker or smoking within the past year.
(7) Cohabiting with another study participant.
(8) Anticipating significant life changes (e.g., moving, job transfer) during the study.
(9) Use of medications affecting study outcomes (e.g., antibiotics, probiotics) within 1 month prior to or during the study.
(10) Receiving continuous oral medication for a medical condition.
(11) History of surgery potentially affecting study outcomes within 6 months prior to consent.
(12) History of appendectomy.
(13) History or current diagnosis of a severe cardiac, hepatic, renal, or digestive disease.
(14) Pregnant, lactating, or planning pregnancy during the study.
(15) Known allergies to drugs or foods.
(16) Donation of blood components or 200 mL whole blood within 1 month prior.
(17) Male with 400 mL whole blood donation within 3 months prior.
(18) Female with 400 mL whole blood donation within 4 months prior.
(19) Males whose 12-month total blood draw (including this study) would exceed 1200 mL.
(20) Females whose 12-month total blood draw (including this study) would exceed 800 mL.
(21) Deemed unsuitable for participation by the investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tatsuhiro |
| Middle name | |
| Last name | Nomaguchi |
Organization
Metagen, Inc.
Division name
Headquarters
Zip code
997-0052
Address
246-2 Mizukami, Kakuganji, Tsuruoka, Yamagata, Japan
TEL
+81-235-64-0330
research@metagen.co.jp
Public contact
Name of contact person
| 1st name | Fumiko |
| Middle name | |
| Last name | Nakamura |
Organization
CPCC Company Limited
Division name
Clinical Support Division
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongokucho, Chuo-ku, Tokyo, Japan
TEL
+81-3-6225-9001
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
Metagen, Inc.
Institute
Department
Personal name
Funding Source
Organization
Mannanlife 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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongokucho, Chuo-ku, Tokyo 103-0021, Japan
Tel
+81-3-6225-9005
IRB@cpcc.co.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 | 09 | Month | 19 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 07 | Month | 23 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 18 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 22 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 22 | 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 | 19 | Day |
Last modified on
| 2025 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067370
