UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057511 |
|---|---|
| Receipt number | R000065186 |
| Scientific Title | Study on changes in intestinal microflora and metabolites due to amazake consumption |
| Date of disclosure of the study information | 2025/04/10 |
| Last modified on | 2026/04/08 21:09:38 |
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Basic information
Public title
Study on changes in intestinal microflora and metabolites due to amazake consumption
Acronym
Study on changes in intestinal microflora and metabolites due to amazake consumption
Scientific Title
Study on changes in intestinal microflora and metabolites due to amazake consumption
Scientific Title:Acronym
Study on changes in intestinal microflora and metabolites due to amazake consumption
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of amazake intake on the gut microbiota composition and the metabolites produced by collecting stool samples before and after amazake consumption and analyzing the gut microbiota and its metabolic compounds.
To assess the impact of amazake on overall health by conducting body measurements, lifestyle surveys, dietary intake assessments, and blood tests before and after amazake consumption to analyze changes in these parameters combining with evaluations of gut microbiota and fecal metabolites.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in fecal metabolites and gut microbiota.
Key secondary outcomes
Fecal bioactive substances, immune factors, metabolic enzymes, microbial genes; general blood test parameters; blood bioactive substances, immune factors, metabolites, metabolic enzymes; body measurements, physical condition, and lifestyle habits.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
A two-week consumption of amazake with added soy and inulin, adjusted for flavor.
Interventions/Control_2
A two-week consumption of amazake with added germinated pressed barley and inulin, adjusted for flavor.
Interventions/Control_3
A two-week consumption of amazake with oligosaccharide, adjusted for flavor.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participants must be part of the study "Research on the Relationship Between Lifestyle Habits and Resident Microbiota" conducted by the Health Lab Station and the National Institutes of Biomedical Innovation, Health, and Nutrition.
Participants must attend an explanatory session and express their willingness to participate in the study.
Previously collected data from observational studies, including vitamin B1 intake, the proportion of butyrate-producing bacteria in stool, and the levels of butyrate and acetate in stool, must be available.
Key exclusion criteria
Individuals who regularly consume amazake, those with allergies to rice, wheat, or soy, and those deemed unsuitable as participants (e.g., individuals unable to properly collect samples, unable to provide health examination results and related information, or those who may have difficulty continuing the intervention, such as those with a history of adverse reactions to amazake consumption)
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | OMURA |
| Middle name | |
| Last name | TOMONORI |
Organization
CORAZON Corporation
Division name
CEO
Zip code
162-0825
Address
2F, 1-12-6 Kagurazaka, Shinjuku-ku, Tokyo, Japan
TEL
03-5579-2328
omura-t@corazon.jp
Public contact
Name of contact person
| 1st name | YUKA |
| Middle name | |
| Last name | KAWAMURA |
Organization
CORAZON Corporation
Division name
Branding Department
Zip code
162-0825
Address
2F, 1-12-6 Kagurazaka, Shinjuku-ku, Tokyo, Japan
TEL
090-4301-4139
Homepage URL
kawamura-y@corazon.jp
Sponsor or person
Institute
CORAZON Corporation
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
National Institutes of Biomedical Innovation, Health and Nutrition
Name of secondary funder(s)
General Incorporated Association, Precision Healthcare Research Organization
IRB Contact (For public release)
Organization
Precision Healthcare Research Organization
Address
609, OAP Tower, 1-8-30 Tenmabashi, Kita-ku, Osaka, Japan
Tel
06-4309-6075
info@j-phr.org
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 | 04 | Month | 10 | 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
24
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
| 2025 | Year | 04 | Month | 03 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 03 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2025 | Year | 12 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 04 | Month | 04 | Day |
Last modified on
| 2026 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000065186
