UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061055 |
|---|---|
| Receipt number | R000069860 |
| Scientific Title | Effects of continuous intake of test food on intestinal microbiota and dietary habits |
| Date of disclosure of the study information | 2026/03/25 |
| Last modified on | 2026/03/25 16:12:59 |
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Basic information
Public title
Effects of continuous intake of test food on intestinal microbiota and dietary habits
Acronym
Effects of continuous intake of test food on intestinal microbiota and dietary habits
Scientific Title
Effects of continuous intake of test food on intestinal microbiota and dietary habits
Scientific Title:Acronym
Effects of continuous intake of test food on intestinal microbiota and dietary habits
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To exploratorily evaluate the effects of 4-week continuous intake of test food on intestinal microbiota and dietary habits in adults (18 to 64 years old).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intestinal microbiota analysis
Key secondary outcomes
Food Frequency Questionnaire (FFQ), Subjective Assessment of Bowel Habits
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake 15g of test food (syrup containing kestose and inulin) daily for 4 weeks.
Interventions/Control_2
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Persons who received a sufficient explanation of the purpose and contents of the study, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate.
2. Persons who are Japanese aged 18 to 64 years old at the time of consent.
3. Persons who do not have intestinal diseases (including those judged as not needing immediate treatment).
Key exclusion criteria
1. Persons who may develop abdominal pain due to materials containing kestose or inulin.
2. Persons who are currently diagnosed with small or large intestinal diseases (including inflammatory bowel disease (IBD)), or have a history of or scheduled for small or large intestinal resection.
3. Persons who are diagnosed with malignant tumors, or receiving treatment for serious diseases (cranial nerve, heart, kidney, diabetes, or thyroid dysfunction), or have a history of serious diseases such as liver disease (excluding diseases judged by the principal investigator to have no impact on the evaluation of this study, such as treatment for hypertension).
4. Persons who consume a large amount of alcohol (60 g or more per day in terms of alcohol).
5. Persons who are allergic to the test food.
6. Persons who usually consume a large amount of the test food.
7. Persons who regularly use medicines or functional foods (specified health foods, functional foods, and functional nutrition foods) that may affect the intestinal environment.
8. Persons who participated in other studies within one month before the start of the study, or those who plan to participate in other studies after consenting to this study.
9. Persons who are judged as inappropriate by the principal investigator.
10. Persons who are pregnant, breastfeeding, or planning/hoping to become pregnant during the study period.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Takumi |
| Middle name | |
| Last name | Tochio |
Organization
BIOSIS Lab. Co., Ltd.
Division name
CEO
Zip code
470-1101
Address
Room 506, Building No. 11, 1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, JAPAN
TEL
090-6904-6772
takumitochiobiz@gmail.com
Public contact
Name of contact person
| 1st name | Takumi |
| Middle name | |
| Last name | Tochio |
Organization
BIOSIS Lab. Co., Ltd.
Division name
CEO
Zip code
470-1101
Address
Room 506, Building No. 11, 1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, JAPAN
TEL
090-6904-6772
Homepage URL
takumitochiobiz@gmail.com
Sponsor or person
Institute
BIOSIS Lab. Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Yamashin Shoten Co., Ltd., Nambu 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
The Ethics Committee of Healthcare Systems Co., Ltd.
Address
1-14-18, Shirakane, Showa-ku, Nagoya, Aichi, JAPAN
Tel
03-6809-2722
soumu@hc-sys.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 | 03 | Month | 25 | 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 | 02 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 03 | Month | 26 | Day |
Last follow-up date
| 2026 | Year | 12 | 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 | 03 | Month | 25 | Day |
Last modified on
| 2026 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069860
