UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059357 |
|---|---|
| Receipt number | R000067553 |
| Scientific Title | Verification study on improvement of bowel movement by 2-week intake of test food |
| Date of disclosure of the study information | 2026/06/30 |
| Last modified on | 2025/10/09 09:30:24 |
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Basic information
Public title
Verification study on improvement of bowel movement by 2-week intake of test food
Acronym
Verification study on improvement of bowel movement by 2-week intake of test food
Scientific Title
Verification study on improvement of bowel movement by 2-week intake of test food
Scientific Title:Acronym
Verification study on improvement of bowel movement by 2-week intake of test food
Region
| Japan |
Condition
Condition
N/A(healthy adults)
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of ingestion of the test food for 2 weeks on improving stool frequency.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stool frequency, Stool characteristics, fecal amount, postdefecation sensation, Japanese edition CAS-MT
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Oral ingestion of a test food for 2 weeks
Interventions/Control_2
Oral ingestion of a placebo 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
| 64 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)Healthy males and females aged 20 to 64 years
(2)Individuals who have a tendency towards constipation
(3)Individuals who can attend on the designated day
(4)Individuals whose written informed consent has been obtained
Key exclusion criteria
(1)Individuals with a history of diabetes, liver, kidney, gastrointestinal, heart, respiratory, vascular, or other serious diseases
(2)Individuals currently under treatment for diseases, especially internal or gastrointestinal diseases
(3)Individuals with food or drug allergies
(4)Individuals who are continuously receiving treatment with oral drugs (including OTC and prescription drugs)
(5)Individuals who are or are possibly pregnant, or lactating
(6)Individuals who have had a history of abdominal surgery within the past 5 years
(7)Individuals who have been diagnosed with functional constipation, etc. at a medical institution and are under treatment, and patients who are aware of irritable bowel syndrome
(8)Individuals who defecate once or twice a week
(9)Individuals who do not like a test food
(10)Individuals who are current smokers
(11)Individuals who are currently or in the past 3 months habitually taking health foods (Including foods for specified health use and foods with functional claims) or designated quasi-drugs that are claimed to regulate intestinal function, or who plan to take them during the study
(12)Individuals who are currently or in the past 3 months habitually taking Chinese medicine or supplements with intestinal-regulating ingredients (e.g., senna, aloe), or plan to do so during the study
(13)Individuals who may change their lifestyle during the study period (Night shift, long travel, etc.)
(14)Individuals who regularly consume excessive amounts of alcohol (For example, drinkers who consume an average of > 60 g/day of pure alcohol per week: 3 bottles(500ml) of beer) or who cannot abstain from alcohol from the day before to the day of the study
(15)Obtained consent to participate in the study. Individuals who are participating in or planning to participate in another clinical study within 1 month
(16)Other individuals judged by the investigator or the trustee to be inappropriate subjects for the study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Sadao |
| Middle name | |
| Last name | Mori |
Organization
Morinaga & Co., Ltd.
Division name
R&D institute
Zip code
230-8504
Address
2-1-1, Shimosueyoshi, Tsurumi-ku, Yokohama
TEL
045-571-6140
s-mori-ab@morinaga.co.jp
Public contact
Name of contact person
| 1st name | Rina |
| Middle name | |
| Last name | Takayanagi |
Organization
Morinaga & Co., Ltd.
Division name
Health Science and Research Center, R&D institute
Zip code
230-8504
Address
2-1-1, Shimosueyoshi, Tsurumi-ku, Yokohama, Kanagawa
TEL
045-571-6140
Homepage URL
r-takayanagi-be@morinaga.co.jp
Sponsor or person
Institute
Morinaga & Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Morinaga & 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
General Incorporated Association Crinical Research Review Center
Address
2972-8-603 Ishikawamachi Hachioji-shi, Tokyo, 192-0032, JAPAN
Tel
090-3547-6398
crrctakashima@kpd.biglobe.ne.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 | 06 | Month | 30 | 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 | 08 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 23 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 21 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 09 | Day |
Last modified on
| 2025 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067553
