UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062625 |
|---|---|
| Receipt number | R000071688 |
| Scientific Title | Investigation of the Effect of Test Food on the Regulation of intestinal function -A Randomized, Double-Blind, Placebo-Controlled trial- |
| Date of disclosure of the study information | 2026/08/19 |
| Last modified on | 2026/08/19 21:25:16 |
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Basic information
Public title
Investigation of the Effect of Test Food on the Regulation of intestinal function
Acronym
Investigation of the Effect of Test Food on the Regulation of intestinal function
Scientific Title
Investigation of the Effect of Test Food on the Regulation of intestinal function
-A Randomized, Double-Blind, Placebo-Controlled trial-
Scientific Title:Acronym
Investigation of the Effect of Test Food on the Regulation of intestinal function
-A Randomized, Double-Blind, Placebo-Controlled trial-
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of food components in the test food on the regulation of intestinal function in healthy male and female subjects aged 20 to less than 65 years following consumption of the test food.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of bowel function (fecal frequency, number of fecal days, fecal characteristics, fecal output, fecal odor)
Key secondary outcomes
(Secondary outcomes)
Evaluation of Intestinal Flora (16S rRNA Gene Analysis, Organic acids in stool), health-related Quality of Life
(Safety evaluation)
Doctor's questions, Physical measurement, Physical examination, Clinical examination(Hematological test, Blood biochemical test, Urinalysis), Adverse event, side effects
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
Continuous intake of the test foods for 4 weeks.
Interventions/Control_2
Continuous intake of the placebo foods for 4 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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.At informed consent, male/female subjects aged more than or equal to 20, and less than 65 years old
2.Subjects who have a tendency toward constipation with 2 to 5 bowel movements per week.
3.Subjects who received an enough explanation of the test objectives and detail, who have consent ability, who are willing to participate with well understandings and who have signed the informed consent document.
Key exclusion criteria
1.Subjects diagnosed with constipation.
2.Subjects with diabetes, liver, kidney, digestive, heart, respiratory, peripheral vascular, or metabolic diseases, or a history of severe manifestations.
3.Subjects with mental disorders, sleep disorders, or a history of such conditions.
4.Subjects who had a gastrointestinal surgery.
5.Subjects with abnormal parameters in liver and/or kidney function.
6.Subjects with a disease currently under treatment.
7.Subjects who are at risk of having allergic reactions to drugs or foods.
8.Subjects with anemia.
9.Subjects who regularly consume medicines, supplements, or health foods that support the regulation of intestinal function, or foods rich in components that may influence the regulation of intestinal function, such as lactic acid bacteria, bifidobacteria, oligosaccharides, or dietary fiber.
10.Subjects using antibiotics or other drugs affecting intestinal microbiota, or planning to use them during the study.
11.Subjects who have extremely irregular life rhythms due to night work, shift work, etc.
12.Subjects who play high intensity sports and/or are on a diet.
13.Subjects whose eating, sleeping, and other habits are extremely irregular.
14.Subjects unable to discontinue health foods, supplements, or quasi-drugs during the study.
15.Subjects who are under treatment with medications (including OTC and/or prescribed medications).
16.Subjects who consume more than 40 g of alcohol per day.
17.Subjects who smoke 21 or more cigarettes per day.
18.Subjects who participated in another clinical study within 3 months before consent or plan to participate during this study.
19.Subjects who have undergone blood donation (200 mL or more within 1 month, or 400 mL or more within 3 months prior to giving informed consent).
20.Subjects who are pregnant, planning to become pregnant during the study period, or currently breastfeeding.
21.Subjects judged unsuitable for the study by the investigator.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tatsuhiko |
| Middle name | |
| Last name | Hirota |
Organization
Asahi Quality & Innovations, Ltd
Division name
Core Technology Laboratories
Zip code
302-0106
Address
1-1-21 Midori, Moriya, Ibaraki 302-0106, Japan
TEL
0297-46-4064
tatsuhiko.hirota@asahi-qi.co.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Terashima |
Organization
Oneness support Co., Ltd.
Division name
Clinical trial Division
Zip code
530-0044
Address
Higashitenma building 6F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
TEL
06-4801-8917
Homepage URL
mterashima@oneness-sup.co.jp
Sponsor or person
Institute
Miura Clinic, Medical Corporation Kanonkai
Institute
Department
Personal name
Funding Source
Organization
Asahi Quality & Innovations, 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 Miura Clinic, Medical Corporation Kanonkai
Address
Higashitenma building 4F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
Tel
06-6809-5220
mterashima@oneness-sup.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
医療法人花音会みうらクリニック（大阪府） Miura Clinic, Medical Corporation Kanonkai（Osaka）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 19 | 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 | 22 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 06 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2027 | 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 | 08 | Month | 19 | Day |
Last modified on
| 2026 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071688
