UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060011 |
|---|---|
| Receipt number | R000068635 |
| Scientific Title | Effects of the consumption of test product on urination in healthy Japanese adults: a randomized, placebo-controlled, double-blind, parallel-group comparison trial |
| Date of disclosure of the study information | 2025/12/08 |
| Last modified on | 2025/12/08 11:04:40 |
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Basic information
Public title
Effects of the consumption of test product on urination in healthy Japanese adults
Acronym
Effects of the consumption of test product on urination in healthy Japanese adults
Scientific Title
Effects of the consumption of test product on urination in healthy Japanese adults: a randomized, placebo-controlled, double-blind, parallel-group comparison trial
Scientific Title:Acronym
Effects of the consumption of test product on urination in healthy Japanese adults
Region
| Japan |
Condition
Condition
Healthy Japanese
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of test product consuming on urination in healthy adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Measured value for the Overactive Bladder Questionnaire (OAB-q) questionnaire item "frequent urination during the daytime hours" after the 8-week intervention (8 w)
Key secondary outcomes
1. Individuals whose the response to the OAB-q questionnaire item "frequent urination during the daytime hours" improved by one or more scale points at 8w compared to screening (Scr)
2. The amount of change, and percentage of change from Scr for the OAB-q questionnaire item "frequent urination during the daytime hours" at 8w
3. The measured values, amount of changes, and percentage of changes from Scr for the OAB-q questionnaire items "Symptom Bother," "Coping," "Concern," "Sleep," "Social Interaction," "Impact on QOL," and all other questionnaire items, excluding "frequent urination during the daytime hours," at 8w
4. The measured values, and amount of changes and percentage of changes from Period 1 for the average frequency of urination during the daytime, during the nighttime, and all day, as measured during Periods 2 to 9
*Period 1: 7 days prior to Scr
Period 2~9: Periods separated by 7 days from the start of intervention
5. Individuals who experienced adverse events
6. Individuals whose values of urinalysis and peripheral blood test are outside the reference range after intervention despite within the reference range at Scr
7. Physical examination, urinalysis, and peripheral blood examination
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
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Duration: Eight weeks
Test product: Tablet containing 120 mg cranberry phospholipids
Administration: Two tablets/day
Interventions/Control_2
Duration: Eight weeks
Test product: Placebo
Administration: Two tablets/day
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Japanese
2. Men or women
3. Adults
4. Healthy individuals
5. Individuals with positive urine leukocytes at Scr
6. Individuals whose score of urinary urgency of overactive bladder symptom score (OABSS) is less than two or total score of OABSS is less than three at Scr
7. Individuals whose "frequent urination during the daytime hours" of "symptom bother" of OAB-q is relatively high at Scr
Key exclusion criteria
1. Individuals undergoing medical treatment or having a medical history of malignant tumor, heart failure, or myocardial infarction
2. Individuals carrying a pacemaker or an implantable cardioverter defibrillator
3. Individuals undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Individuals who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage as part of their daily diet
5. Individuals currently regularly taking medications (including herbal medicines) and supplements
6. Individuals who are allergic to medicines and/or the test-product-related products in this trial
7. Individuals with urinary pain
8. Individuals undergoing treatment, have had treatment within two months, or need the treatment for diseases related to urination, e.g. benign prostatic hypertrophy, prostatitis, prostate cancer, overactive bladder, hypoactive bladder, cystitis, interstitial cystitis, bladder cancer, bladder stones, urethritis, urethral stricture, neurological disease, polyuria, and nocturnal polyuria
9. Individuals have overactive bladder symptom (individuals who urinate eight times or more per day, and have urinary urgency at least once a week)
10. Individuals wake up twice or more to urinate at bedtime
11. Individuals are pregnant, breast-feeding, and planning to become pregnant
12. Individuals have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial
13. Individuals are judged as ineligible to participate in the trial by the physician
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Takara |
Organization
Medical Corporation Seishinkai, Takara Clinic
Division name
Director
Zip code
141-0022
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
TEL
03-5793-3623
t-takara@takara-clinic.com
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Suzuki |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan
TEL
03-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
Indena S.p.A. Medical Department at Product Portfolio Office
Institute
Department
Personal name
Funding Source
Organization
Indena S.p.A.
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Indena Japan Co., Ltd.
IRB Contact (For public release)
Organization
The ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
Tel
03-5793-3623
IRB@takara-clinic.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
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 08 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 11 | Month | 07 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 07 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 08 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 19 | 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 | 12 | Month | 08 | Day |
Last modified on
| 2025 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068635
