UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061454 |
|---|---|
| Receipt number | R000070222 |
| Scientific Title | Effects of cranberry extract supplementation on improvement of urinary symptoms: a randomized, double-blind, placebo-controlled, parallel-group trial |
| Date of disclosure of the study information | 2026/10/13 |
| Last modified on | 2026/10/12 16:27:18 |
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Basic information
Public title
The effects of cranberry extract supplementation on urinary symptoms in healthy adults
Acronym
Cranberry urinary study
Scientific Title
Effects of cranberry extract supplementation on improvement of urinary symptoms: a randomized, double-blind, placebo-controlled, parallel-group trial
Scientific Title:Acronym
A study of the effects of cranberry extract intake on urinary symptom improvement in healthy adults
Region
| Japan |
Condition
Condition
Healthy adults with urinary concerns
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of cranberry extract supplementation on urinary symptoms (urinary frequency, urgency, intimate zone discomfort, etc.) in healthy adults with urinary concerns
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Urinary QOL assessment using OAB-q and CLSS (Conservative Lifestyle Score Sheet)
Key secondary outcomes
VSQ (Vulvovaginal Symptoms Questionnaire) VAS Urinary diary (supplementary indicator for voiding frequency) PSQI-j (supplementary indicator for nocturia) POMS (exploratory)
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
Take cranberry extract capsules 100mg (proanthocyanidin 9% specification) for 4 weeks (28 days)
Interventions/Control_2
Take placebo capsules for 4 weeks (28 days)
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
| 30 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Female
Key inclusion criteria
(1) Persons who are generally judged as healthy
(2) Persons who can give voluntary written informed consent
(3) Persons with OABSS total score of 3 or more
(4) Persons with OABSS question 3 (urgency) score of 2 or more (urinary urgency at least once per week)
(5) Persons not diagnosed with lower urinary tract disease, overactive bladder, or sexually transmitted infections
Key exclusion criteria
(1) Persons with suspected overactive bladder or prostatic hyperplasia
(2) Persons currently under urological treatment
(3) Persons taking health foods that affect urination (cranberry, saw palmetto, pumpkin seed, pomegranate, etc.) once or more per week, or persons continuously taking medicines with similar effects to this study
(4) Persons who changed/newly started supplements within past 4 weeks
(5) Pregnant, breastfeeding, or planning pregnancy during study period
(6) Persons who participated in another human trial within past 4 weeks
(7) Persons deemed unsuitable by the investigator
(8) Persons experiencing intimate zone discomfort (itching, irritation, etc.) or swelling sensation in the face or legs
(9) Persons who have urinary tract infections, urinary stones, kidney stones, ureteral stones, gallstones, or infections such as chlamydia or syphilis
Target sample size
30
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
0948-82-3123
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
Others
Institute
Department
Personal name
Funding Source
Organization
Others
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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, Iizuka City, Fukuoka
Tel
0948-82-3123
userlifesciense@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
株式会社ユーザーライフサイエンス（福岡県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 13 | 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
Completed
Date of protocol fixation
| 2026 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 08 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 07 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | 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 | 05 | Month | 05 | Day |
Last modified on
| 2026 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070222
