UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058455 |
|---|---|
| Receipt number | R000066799 |
| Scientific Title | Investigation of the effects of the test food on the regulation of intestinal function |
| Date of disclosure of the study information | 2025/07/14 |
| Last modified on | 2025/07/11 11:14:31 |
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Basic information
Public title
Investigation of the effects of the test food on the regulation of intestinal function
Acronym
Investigation of the effects of the test food on the regulation of intestinal function
Scientific Title
Investigation of the effects of the test food on the regulation of intestinal function
Scientific Title:Acronym
Investigation of the effects of the test food on the regulation of intestinal function
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 (defecation frequency, number of defecation days, fecal output)
Key secondary outcomes
(Secondary outcomes)
Evaluation of bowel function(defecation questionnaire(stool consistency, stool color, stool color, post-defecation feeling)), Evaluation of Intestinal Flora (16S rRNA Gene Analysis), extracellular water ratio, Visual analog scale (swelling, skin, QOL)
(Safety evaluation)
Vital signs, physical measurements (weight, BMI), blood biochemistry, hematology, adverse events
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 2 weeks.
Interventions/Control_2
Continuous intake of the placebo foods 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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Japanese males and females who are aged 20 to less than 65 at the time of written informed consent.
2.Subjects who have a tendency toward chronic constipation with 2 to 4 bowel movements per week.
3.Subjects who are fully explained the purpose and details of the study, have ability to consent, are volunteering to participate in the study with a full understanding of the explanation, and have consented to participate in the study.
Key exclusion criteria
1.Subjects diagnosed with constipated by a physician.
2.Subjects with brain disease, malignancies, immune disease, diabetes mellitus, liver disease (hepatitis), kidney, heart, thyroid, adrenal, and metabolic diseases, and subjects who currently have or previously had serious manifestations of these conditions.
3.Subject receiving medication or outpatient treatment for a serious disease.
4.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.
5.Subjects who are receiving drugs that affect the intestinal microbiota such as antibiotics ,or subjects who plan to take such medication during the test period.
6.Subjects who are at risk of having allergic reactions to drugs or foods.
7.Subjects with current or previous history of drug dependence or alcohol dependence.
8.Heavy users of alcohol (the mean consumption of pure alcohol is 60 g/day or more).
9.Subjects receiving exercise or diet therapy under the supervision of a physician.
10.Subjects who have extremely irregular life rhythms due to night work, shift work, etc.
11.Subjects whose eating, sleeping, and other habits are extremely irregular.
12.Subject who is attending a hospital due to mental disorders (depression, etc.) or sleep disorders (insomnia, sleep apnea syndrome, etc.) , or who has a history of mental illness in the past.
13.Subjects who are having a very unbalanced diet.
14.Smoker
15.Subjects who are currently pregnant or lactating, may become pregnant during the study period.
16.Subjects who participated in another clinical study/research within 3 months before the date of informed consent or who plan to participate in another clinical study/research during the study period.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Hirosuke |
| Middle name | |
| Last name | Sgahara |
Organization
Asahi Quality & Innovations, Ltd
Division name
Department of Brewing science III
Zip code
302-0106
Address
1-21,MIDORI 1-CHOME, MORIYA-SHI, IBARAKI,302-0106
TEL
080-7789-1246
hirosuke.sugahara@asahi-qi.co.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Miyazawa |
Organization
HUMA R&D CORP
Division name
Clinical Development Department
Zip code
108-0023
Address
NAKANO SPRING Bldg 5F, 4-11-17 Shibaura, Minato-ku, Tokyo 108-0023 Japan
TEL
03-3431-1260
Homepage URL
rd@huma-rd.co.jp
Sponsor or person
Institute
HUMA R&D CORP
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
Tokyo Shinjuku Clinic Ethical Review Board
Address
5F,SIL Shinjuku-building,2-46-3,Kabukicho,Shinjuku-ku,Tokyo,160-0021,Japan
Tel
03-6709-6071
tokyoshinjuku@taifukukai.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
| 2025 | Year | 07 | Month | 14 | 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 | 07 | Month | 04 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 11 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 14 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(Exclusion criteria continued)
17.Subjects who donated more than 200 mL of whole blood, plasma, or platelets within 1 month before the date of informed consent or 400 mL within 3 months before the date of informed consent.
18.Subjects who have difficulty complying with recording of each survey form.
19.Subjects whose laboratory test values or various test results at screening indicate their ineligibility to participate in the study.
Management information
Registered date
| 2025 | Year | 07 | Month | 14 | Day |
Last modified on
| 2025 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066799
