UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060262 |
|---|---|
| Receipt number | R000068898 |
| Scientific Title | Verification of the Comprehensive Health Effects Originating from the Gut Environment of the Test Food |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2026/01/05 18:24:57 |
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Basic information
Public title
Verification of the Comprehensive Health Effects Originating from the Gut Environment of the Test Food
Acronym
Verification of the Comprehensive Health Effects Originating from the Gut Environment of the Test Food
Scientific Title
Verification of the Comprehensive Health Effects Originating from the Gut Environment of the Test Food
Scientific Title:Acronym
Verification of the Comprehensive Health Effects Originating from the Gut Environment of the Test Food
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine the effects of consuming the test food on bowel movements, sleep, mental health, and other related parameters.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gut microbiota after 4 weeks of test food intake.
Key secondary outcomes
Bowel Movement Survey, the Pittsburgh Sleep Quality Index (PSQI), the Patient Health Questionnaire-9 (PHQ-9), the MOS Short-Form 36-Item Health Survey (SF-36), cytokine levels, antibody titers
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
Participants will freely consume the test food, an unprocessed food that has been eaten in Japan since ancient times, twice a day at home for four weeks.
Interventions/Control_2
Participants will freely consume the placebo test food - an unprocessed food - twice daily at home for a period of four 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
| 18 | years-old | <= |
Age-upper limit
| 30 | years-old | > |
Gender
Female
Key inclusion criteria
Participants will be healthy adult women who understand the study's purpose and content and submit written informed consent before the start of the trial.
Key exclusion criteria
Individuals with barley or wheat allergies, as well as those who regularly use supplements or medications that may affect bowel movements, sleep, or mental health, will be excluded.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | MARI |
| Middle name | |
| Last name | HONDA |
Organization
Kobe Women's University
Division name
Department of Health, Sports, and Nutrition, Faculty of Health and Welfare
Zip code
650-0046
Address
4-7-2 Minatojima-nakamachi, Chuo-Ku, Kobe City, Hyogo
TEL
078-303-4700
mhonda@kwjc.kobe-wu.ac.jp
Public contact
Name of contact person
| 1st name | HONDA |
| Middle name | |
| Last name | MARI |
Organization
Kobe Women's University
Division name
Department of Health, Sports, and Nutrition, Faculty of Health and Welfare
Zip code
650-0046
Address
4-7-2 Minatojima-nakamachi, Chuo-Ku, Kobe City, Hyogo
TEL
078-303-4700
Homepage URL
mhonda@kwjc.kobe-wu.ac.jp
Sponsor or person
Institute
Kobe Women's University
Institute
Department
Personal name
Funding Source
Organization
Kobe Women's University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe Women's University Human Research Ethics Committee
Address
4-7-2 Minatojima-nakamachi, Chuo-Ku, Kobe City, Hyogo
Tel
078-303-4700
mhonda@kwjc.kobe-wu.ac.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 | 04 | Month | 01 | 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 | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 05 | Month | 11 | Day |
Last follow-up date
| 2026 | Year | 07 | 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 | 01 | Month | 05 | Day |
Last modified on
| 2026 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068898
