UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061610 |
|---|---|
| Receipt number | R000070488 |
| Scientific Title | Effects of consumption of the test food on the gut microbial metabolites in healthy adults |
| Date of disclosure of the study information | 2026/05/28 |
| Last modified on | 2026/05/28 16:48:47 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of consumption of the test food on the gut microbial metabolites in healthy adults
Acronym
Effects of consumption of the test food on the gut microbial metabolites in healthy adults
Scientific Title
Effects of consumption of the test food on the gut microbial metabolites in healthy adults
Scientific Title:Acronym
Effects of consumption of the test food on the gut microbial metabolites in healthy adults
Region
| Japan |
Condition
Condition
Healthy Japanese subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the effect of consumption of the test food on the gut microbial metabolites in healthy adults
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gut microbial metabolite X
Key secondary outcomes
Gut microbial metabolites other than X
Gut microbiota
Defecation status
Water content in feces
pH value in feces
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Daily intake of test food for 2 weeks -> Washout for 3 weeks -> Daily intake of placebo food for 2 weeks
Interventions/Control_2
Daily intake of placebo food for 2 weeks -> Washout for 3 weeks -> Daily intake of test food for 2 weeks
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
Eligibility criteria for participation in the screening:
1) Healthy adults aged 20 years or older
2) Subjects with a bowel movement frequency of at least twice per week
3) Subjects who are 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 to personally sign a written informed consent
Selection criteria in the screening:
1) Subjects who endogenously possess gut microbial metabolite X will be selected for participation in the subsequent intervention study
Key exclusion criteria
1) Subjects with severe cardiovascular, respiratory, gastrointestinal, urinary, endocrine, or hematological disease
2) Subjects with hypothyroidism
3) Subjects who, at the time of informed consent, are receiving treatment at a medical institution for the treatment or prevention of disease, including hormone therapy, pharmacotherapy, exercise therapy, or diet therapy, or who are judged to be in a condition requiring such treatment
4) Subjects with food or drug allergies
5) Subjects who habitually consume foods for specified health uses, foods with functional claims, supplements, or health foods rich in dietary fiber for the purpose of regulating bowel function or improving the intestinal environment
6) Subjects who consume excessive amounts of alcohol (average weekly alcohol intake exceeding 60 g/day [Reference Materials for Health Japan 21 (the Second Term)])
7) Subjects who are pregnant, breastfeeding, or intending to become pregnant during the study period
8) Subjects who are participating in another clinical study, including a clinical trial
9) Subjects who are judged by the principal investigator to be unsuitable for participation in the study
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Yayoi |
| Middle name | |
| Last name | Gotoh |
Organization
Fujicco Co., Ltd.
Division name
R&D Department
Zip code
650-8558
Address
6-13-4 Minatojima-Nakamachi, Chuo-ku, Kobe, Hyogo, Japan
TEL
078-303-5191
y-gotoh@fujicco.co.jp
Public contact
Name of contact person
| 1st name | Masamichi |
| Middle name | |
| Last name | Watanabe |
Organization
Fujicco Co., Ltd.
Division name
R&D Department
Zip code
650-8558
Address
6-13-4 Minatojima-Nakamachi, Chuo-ku, Kobe, Hyogo, Japan
TEL
078-303-5191
Homepage URL
m-watanabe@fujicco.co.jp
Sponsor or person
Institute
Fujicco Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Fujicco 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
Ethical review committee of Fujicco Co., Ltd.
Address
6-13-4 Minatojima-Nakamachi, Chuo-ku, Kobe, Hyogo, Japan
Tel
078-303-5191
research@fujicco.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 | 05 | Month | 28 | 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
18
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
Completed
Date of protocol fixation
| 2024 | Year | 08 | Month | 07 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 13 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | 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 | 05 | Month | 18 | Day |
Last modified on
| 2026 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070488
