UMIN-CTR Clinical Trial

Basic information
Public title	A study of the effect of improving urinary problems with foods containing Brazilian green propolis extract, pumpkin seed extract and cranberry extract in healthy women
Acronym	A study of the effect of improving urination problems by ingesting functional foods
Scientific Title	A study of the effect of improving urinary problems with foods containing Brazilian green propolis extract, pumpkin seed extract and cranberry extract in healthy women
Scientific Title:Acronym	A study of the effect of improving urination problems by ingesting functional foods
Region	Japan

Condition
Condition	Adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine the efficacy of test food on female who urinate twice or more during nighttime, how test food would reduce the frequency of nocturnal urination
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	frequency of nocturnal urination
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	functional food Intake:810 mg Ingesion:28day
Interventions/Control_2
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	50 years-old <=
Age-upper limit	80 years-old >
Gender	Female
Key inclusion criteria	1. Healthy Japanese men and women aged more than 50 years, less than 80 years at the time of giving informed consent. 2. Individuals who are aware of frequent urination, who are suffering from frequent urination. 3. Individuals who urinate more than once at night for more than 3 months 4. Individuals who has freely given consent and has understood the purpose of the study. 5. BMI:18.5 - 30.0 6. Individuals who are considered fit for the enrollment in the clinical study.
Key exclusion criteria	1. Individuals who undergoing treatment for urinary disorders such as overactive bladder, bladder inflammation, and urethral stones. 2. Individuals with a current history of diabetes, cerebrovascular accidents, sequelae of stroke, spinal cord disorders, spinal degenerative disorders, sleep disorders, and hypertension. 3. Individuals who have a disorder to absorption, distribution, metabolism, excretion of food, such as digestive tract, liver, kidney, heart and cardiovascular system. 4. Individuals with a history of the surgery considerable in the gastrointestinal tract site, for example, gastrectomy, stomach and intestines suturation, intestinal tract resection and so on. (Excluding polypectomy and appendectomy) 5. Individuals with current or history of uterine fibroids, endometriosis, or pelvic organ prolapse. 6. Individuals with a history of uterine or pelvic surgery. 7. Individuals who are receiving hormone replacement therapy (estrogen, progesterone preparations (drinks, patches, ointments), etc.), those who plan to take it during the study period. 8. Individuals who regularly overdose beverages containing diuretic ingredients. 9. Individuals with a history of allergies, asthma, or stones. 10. Individuals who regularly take health foods, supplements, and medicines that may affect the test. 11. Be Suspected alcohol or drug dependence. 12. Individuals who have smoked since 3 months of consent. 13. Individuals who participated in other clinical trial at resent (past 84 days) 14. Individuals with irregular lifestyles due to night shifts or shift work. 15. Individuals who live with or will participate in this test. 16. Individuals who cannot comply with the management items during this test. 17. Individuals who work for health food companies, cosmetics companies, pharmaceutical companies. 18. Individuals who judged by the investigator to be inappropriate for participating in the study.
Target sample size	24

Research contact person
Name of lead principal investigator	1st name Yuzuri Middle name Last name Sato
Organization	Koganeibasi Sakura Clinic
Division name	Not applicable
Zip code	184-0005
Address	1-15-11 sakura-cho, koganei-si, Tokyo 184-0005 Japan
TEL	042-382-5101
Email	info@kb-clinic.com

Public contact
Name of contact person	1st name Chizuru Middle name Last name Homma
Organization	Yamada Bee Company, Inc.
Division name	Functional research section, Institute for Bee Products & Health Science, R&D department
Zip code	708-0393
Address	194 Ichiba, Kagamino-cho, Tomata-gun, Okayama 708-0393 Japan
TEL	0868-54-3825
Homepage URL
Email	ch1644@yamada-bee.com

Sponsor
Institute	Yamada Bee Company, Inc.
Institute
Department

Funding Source
Organization	Yamada Bee Company, Inc.
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	Koganeibasi Sakura Clinic Ethics Committee
Address	1-15-11 sakura-cho, koganei-si, Tokyo 184-0005 Japan
Tel	042-382-5252
Email	info.food@kb-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

Other administrative information
Date of disclosure of the study information	2021 Year 05 Month 31 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	26
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	2020 Year 10 Month 12 Day
Date of IRB	2020 Year 10 Month 22 Day
Anticipated trial start date	2020 Year 11 Month 16 Day
Last follow-up date	2021 Year 02 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	2020 Year 12 Month 01 Day
Last modified on	2022 Year 06 Month 27 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048034