UMIN-CTR Clinical Trial

Basic information
Public title	Examination of the effect of test food intake on pollakiuria in women
Acronym	Examination of the effect of test food intake on pollakiuria in women
Scientific Title	Examination of the effect of test food intake on pollakiuria in women
Scientific Title:Acronym	Examination of the effect of test food intake on pollakiuria in women
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the effect of test food intake for 8 consecutive weeks on pollakiuria
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	OAB-q and Bladder diary before and after 4 weeks and 8 weeks, and OABSS before and after 8 weeks
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake of test food once a day for 8 weeks
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	20 years-old <=
Age-upper limit	80 years-old >
Gender	Female
Key inclusion criteria	1)Healthy females from 20 to 79 years of age 2)Daytime urinary frequency is more than 8 times
Key exclusion criteria	1) Subjects who have urinary urgency score >= 2, and total score >= 3 in OABSS 2) Subjects who are LUTS/OAB patients or need to treatment of disease 3) Subjects who routinely use dietary supplements and medicines containing the ingredients involved in the test food 4) Subjects who routinely use dietary supplements and medicines that are said to be effective for pollakiuria 5) Subjects who have a urinary calculus or a history of such diseases 6) Subjects who have a disease requiring regular medication or a history of serious diseases for which medication was required 7) Subjects who have a disease requiring treatment or a history of serious diseases 8) Subjects who have possibilities for emerging allergy related to the study 9) Subjects who drink much alcohol 10) Subjects who cannot follow the procedures of various tests to be carried out during this study 11) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination 12) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study 13) Subjects who are pregnant or breastfeeding and who are going to become pregnant or breastfeed during the study period 14) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire 15) Subjects who are judged as unsuitable for the study by the investigator
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Yoshinori Middle name Last name Hokari
Organization	Maruhachi Muramatsu, Inc.
Division name	Development Research Center Research group
Zip code	425-0065
Address	1355, Souemon, Yaizu, Shizuoka
TEL	054-624-5440
Email	yoshinori.hokari@08m.co.jp

Public contact
Name of contact person	1st name Kotoha Middle name Last name Isobe
Organization	TTC Co., Ltd.
Division name	Clinical Research Planning Department
Zip code	150-0021
Address	Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL	03-5459-5329
Homepage URL
Email	k.isobe@ttc-tokyo.co.jp

Sponsor
Institute	TTC Co., Ltd
Institute
Department

Funding Source
Organization	non-disclosure
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Medical Station Clinic Research Ethics Committee
Address	3-12-8, Takaban, Meguroku, Tokyo
Tel	03-6452-2712
Email	t.saito@ttc-smo.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	2021 Year 12 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	Completed
Date of protocol fixation	2020 Year 09 Month 24 Day
Date of IRB	2020 Year 09 Month 24 Day
Anticipated trial start date	2020 Year 09 Month 28 Day
Last follow-up date	2020 Year 12 Month 14 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 09 Month 25 Day
Last modified on	2021 Year 03 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047819