UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059414 |
|---|---|
| Receipt number | R000067951 |
| Scientific Title | Study on the Effects of Test Food Intake on Urinary Discomfort in Women: a randomized, double-blind, placebo-controlled, parallel-group comparison |
| Date of disclosure of the study information | 2026/07/16 |
| Last modified on | 2026/07/15 13:52:44 |
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Basic information
Public title
Study on the Effects of Test Food Intake on Urinary Discomfort in Women
Acronym
Test Food Intake for Urinary Discomfort
Scientific Title
Study on the Effects of Test Food Intake on Urinary Discomfort in Women: a randomized, double-blind, placebo-controlled, parallel-group comparison
Scientific Title:Acronym
Test Food Intake for Urinary Discomfort: a randomized, double-blind, placebo-controlled, parallel-group comparison
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of test food intake on urinary discomfort in women
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Core Lower Urinary Tract Symptom Score
Key secondary outcomes
Participant diary (frequency, etc. of urinary discomfort symptoms)
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
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Participants will consume the test food for 24 weeks
They will take one packet per day with water or lukewarm water
Interventions/Control_2
Participants will consume the placebo for 24 weeks
They will take one packet per day with water or lukewarm water
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
| 75 | years-old | > |
Gender
Female
Key inclusion criteria
(1) Individuals who are generally considered to be healthy
(2) Women who subjectively experience mild urinary discomfort (e.g., pain during urination, cloudy urine, or residual urine sensation) several times a year
(3) Individuals who can give voluntary written consent to participate in the present trial
Key exclusion criteria
(1) Individuals who regularly consume any dietary supplements, quasi-drugs, or medicines that have the same or similar effects as those evaluated in this study
(2) Individuals who have changed or newly started taking health foods or dietary supplements within the past 4 weeks
(3) Individuals who work night shifts or rotating shifts
(4) Individuals receiving medical or preventive treatment (e.g., hormone replacement, pharmacotherapy, exercise, or dietary therapy) at the time of obtaining informed consent, or judged to require such treatment
(5) Individuals with a history of serious metabolic, hepatic, renal, cardiovascular, respiratory, endocrine, immune, neurological, or psychiatric disorders.
(6) Individuals with a medical history of alcohol or drug dependence
(7) Individuals who might develop an allergic reaction to foods
(8) Individuals who are pregnant, breastfeeding, or intend to become pregnant during the study period
(9) Individuals who have participated in any other human study involving foods, medicines, quasi-drugs, or medical devices within the past 4 weeks, or who plan to participate in another study during the study period
(10) Individuals who are judged by the investigator to be unsuitable for participation in the study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kouichirou |
| Middle name | |
| Last name | Ohnuki |
Organization
User Life Science Co.,Ltd.
Division name
The research and development part
Zip code
820-0115
Address
372-3,Niho,Iiduka-shi,Fukuoka,Japan
TEL
0948823123
ohnuki.rinp@gmail.com
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Ohnuki |
Organization
User Life Science Co.,Ltd.
Division name
The research and development part
Zip code
820-0115
Address
372-3,Niho,Iiduka-shi,Fukuoka,Japan
TEL
0948-82-3123
Homepage URL
userlifescience@gmail.com
Sponsor or person
Institute
User Life Science Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
Sunus 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
User Life Science Co., Ltd. Ethics Committee
Address
372-3,Niho,Iiduka-shi,Fukuoka,Japan
Tel
0948-82-3123
userlifescience@gmail.com
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 | 07 | Month | 16 | 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
40
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
Completed
Date of protocol fixation
| 2025 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 02 | Day |
Last follow-up date
| 2026 | Year | 03 | 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
| 2025 | Year | 10 | Month | 15 | Day |
Last modified on
| 2026 | Year | 07 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067951
