UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study on the effectiveness of USRP001(development code)
Title of the study (Brief title)	A study on the effectiveness of USRP001(development code)
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Urology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To confirm the effectiveness of USRP001(development code) for the urinary functions
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Subjective and objective indicators on urinary functions before and after the intake of test foods for 4weeks
Key secondary outcomes	Subjective and objective indicators on sleep quality, autonomic nervous activity, physical activity and biochemical components in blood and urine before and after the intake of test foods for 4weeks

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	-Intake USRP001(development code) twice a day for 4weeks -Washout for 4 weeks -Intake placebo foods twice a day for 4weeks
Interventions/Control_2	-Intake placebo foods twice a day for 4weeks -Washout for 4 weeks -Intake USRP001(development code) twice a day for 4weeks
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	59 years-old >=
Gender	Male
Key inclusion criteria	Healthy males
Key exclusion criteria	1.Subjects who attend a hospital or who take drugs 2.Subjects who are always under the weather 3.Subjects who underwent the surgery of urinary functions 4.Subjects who have had brain spinal cord injury, cystitis, vesicoureteral reflux, ureteral stone, prostatitis, urethritis or prostatic hyperplasia 5.Subjects who have had severe diseases 6.Subjects who drink water over 2.5L a day 7.Subjects who cannot intake test foods 8.Subjects who cannot measure EEG, autonomic nervous activity or physical activity 9.Subjects who has allergy to medical tapes or electrodes 10.Subjects who participate in the other examinations which have an influence on this examination 11.Subjects deemed inappropriate to participate in this study by the principle investigator
Target sample size	15

Research contact person
Name of lead principal investigator	Takatoshi Murase
Organization	Kao Corporation
Division name	R&D -Core Technology- Biological Science Research
Address	2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL	0285-68-7871
Email	murase.takatoshi@kao.co.jp

Public contact
Name of contact person	Naoya Kitamura
Organization	Kao Corporation
Division name	R&D -Core Technology- Biological Science Research
Address	2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL	0285-68-7458
Homepage URL
Email	kitamura.naoya@kao.co.jp

Sponsor
Institute	Kao Corporation
Institute
Department

Funding Source
Organization	Kao Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

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	花王株式会社栃木事業場（栃木県）

Other administrative information
Date of disclosure of the study information	2016 Year 08 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 27 Day
Anticipated trial start date	2016 Year 08 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 08 Month 02 Day
Last modified on	2017 Year 04 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027012