UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062327 |
|---|---|
| Receipt number | R000071256 |
| Scientific Title | Evaluation Study on Preventive Health Measures Through Improvement of the Gut Microbiome via Consumption of Test Foods |
| Date of disclosure of the study information | 2026/07/27 |
| Last modified on | 2026/07/24 10:34:19 |
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Basic information
Public title
Evaluation Study on Preventive Health Measures Through Improvement of the Gut Microbiome via Consumption of Test Foods
Acronym
Evaluation Study on Preventive Health Measures Through Improvement of the Gut Microbiome via Consumption of Test Foods
Scientific Title
Evaluation Study on Preventive Health Measures Through Improvement of the Gut Microbiome via Consumption of Test Foods
Scientific Title:Acronym
Evaluation Study on Preventive Health Measures Through Improvement of the Gut Microbiome via Consumption of Test Foods
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the effectiveness of selecting gut health improvement solutions based on gut microbiota profiles, and assessment of their association with physical condition and health screening parameters
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total Short-Chain Fatty Acids in Feces (Total of Acetic Acid, Propionic Acid, and Butyric Acid)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Test Group 1: A group that consumed low-sugar granola containing prebiotic ingredients tailored to the gut bacteria most prevalent in the individual test subjects
Interventions/Control_2
Test Group 2: A group that consumed low-sugar granola containing prebiotic ingredients tailored to the gut bacteria least prevalent in the individual test subjects
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 Individuals who are 20 years of age or older at the time consent is obtained
2 Individuals who reside or work in Kanagawa Prefecture at the time consent is obtained
3 Individuals who can consume granola daily
4 Individuals who can collect stool samples and perform fingerstick blood draws at home and mail them to the designated testing facility
5 Individuals who can independently complete online questionnaires, maintain a lifestyle diary, and update their My ME-BYO Medical Record via a PC or smartphone
6 Individuals who have received a thorough explanation of this study, are able to understand its contents, and can provide their own informed consent
Key exclusion criteria
1 Individuals who have taken medications that may affect the trial (such as antibiotics, probiotics, or laxatives) within one month prior to Screening 1, or who plan to take such medications during the trial period
2 Individuals who have undergone surgery that is considered likely to affect the trial within six months prior to obtaining informed consent (such as colonoscopy, gallstone or gallbladder removal, or gastric bypass surgery)
3 Individuals who are pregnant, breastfeeding, or intend to become pregnant during the trial period
4 Individuals for whom significant changes in their living environment (e.g., family or work circumstances, such as moving or a job transfer) are anticipated during the trial period
5 Individuals with a history or current diagnosis of liver cancer, inflammatory bowel disease, Crohn's disease, or Parkinson's disease
6 Individuals with allergies to medications or foods
7 Participants who are currently participating in a clinical trial for another pharmaceutical product or dietary supplement, who have done so within the past 4 weeks, or who plan to participate in another clinical trial after providing informed consent for this trial
8 Any other participants deemed unsuitable for this trial by the principal investigator or the trial representative
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Shinji |
| Middle name | |
| Last name | Fukuda |
Organization
Metagen,Inc.
Division name
Headquarters
Zip code
997-0052
Address
246-2 Mizukami, Kakuganji, Tsuruoka, Yamagata, Japan
TEL
+81-235-64-0330
clinical-trials@metagen.co.jp
Public contact
Name of contact person
| 1st name | Maki |
| Middle name | |
| Last name | Funada |
Organization
CPCC Company Limited
Division name
Clinical Trials Planning Department
Zip code
103-0021
Address
4th Floor, Daiwa Building, 3-3-10 Nihonbashi-Honishicho, Chuo-ku, Tokyo, Japan
TEL
+81-3-5297-5548
Homepage URL
IRB@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
Kanagawa Prefecture Town, People, and Jobs Revitalization Fund: Research and Development Project on the Regional Implementation of Pre-disease Indicators (Gut Microbiome, etc.)
Organization
Division
Category of Funding Organization
Local Government
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
2nd Floor, Daiwa Building, 3-3-10 Nihonbashi-Honishicho, Chuo-ku, Tokyo, Japan
Tel
+81-3-5297-5548
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
| 2026 | Year | 07 | Month | 27 | 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
| 2026 | Year | 07 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 08 | Month | 17 | Day |
Last follow-up date
| 2028 | 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
| 2026 | Year | 07 | Month | 24 | Day |
Last modified on
| 2026 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071256
