UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of the Test Food on Voiding
Title of the study (Brief title)	Effect of the Test Food on Voiding
Region	Japan

Condition
Condition	N/A (healthy adults)
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aims to examine effect of the test food on voiding.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	[1]Voiding diary (From the first day of ingestion of a test material to the last day of the test)
Key secondary outcomes	*Secondary outcomes [1]Indexes on sleeping (Pittsburgh Sleep Quality Index, OSA sleep inventory [Screening, Day 0 of observation Period I, Day 14 of Observation Period I, Day 0 of Observation Period II, Day 14 of Observation Period II). [2]Indexes on physical condition (Japanese Translation of Profile of Mood States, SF-8 Acute version [Day 0 of Observation Period I, Day 14 of Observation Period I, Day 0 of Observation Period II, Day 14 of Observation Period II]). *Safety [1]Blood pressure, pulsation (Screening, Day 14 of Observation Period II) [2]Weight, body fat percentage, BMI (Screening, Day 14 of Observation Period II) [3]Doctor's questions (Screening, Day 14 of Observation Period II) [4]Subject's diary(From the first day of ingestion of a test material to the last day of the test) *Other indexes [1]Hematologic test (Screening) [2]Blood biochemical test (Screening) [3]Urine analysis (Screening) [4]Overactive Bladder Symptom Score (Screening) [5]International Prostate Symptom Score (1) (Screening) [6]Simplified Menopausal Index (2) (Screening) (1)Only male subjects. (2)Only female subjects.

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Oral intake of a test product (Observation Period I: 14days). >Wash out period (14 days). >Oral intake of a placebo product (Observation Period II: 14days).
Interventions/Control_2	Oral intake of a placebo product (Observation Period I: 14days). >Wash out period (14 days). >Oral intake of a test product (Observation Period II: 14days).
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	40 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	[1]Males and females aged 40-65 years. [2]Individuals who are healthy and don't receive treatment. [3]Individuals whose urinary frequencies in the daytime are 8-14 times and who wake up to urinate during asleep is less than 1 time. [4]Individuals whose lights-out and weak-up time is regular, land time of sleeping is over 5 hours. [5]Individuals whose written informed consent has been obtained. [6]Individuals judged appropriate for the trial by the principal.
Key exclusion criteria	[1]Individuals using medical products. [2]Individuals who use a drug for treatment of disease. [3]Individuals who are suspected patient of, a patient of, or had a history of sleep apnea syndrome. [4]Individuals who have or are suspected patient of nocturia, benign prostatic hyperplasia, overactive bladder. [5]Individuals who used a drug to treat a disease in the past 1 month. [6]Individuals who have a history of heart failure, kidney failure, hepatitis B or hepatitis C. [7]Individuals who have a history of digestive system disease. [8]Individuals whose score of the Overactive Bladder Symptom Score in Question 3 is over 3 points and total points are over 2(1). [9]Individuals whose score of the International Prostate Symptom Score is over 8 points (1). [10]Individuals whose score of the Simplified Menopausal Index is over 50 points (2). [11]Individuals whose BMI is over 30. [12]Individuals whose PSA level is over 4.0 ng/m (1). [13]Individuals who have a drinking habit. [14]Individuals with serious anemia. [15]Individuals who are sensitive to a test product or other foods, and medical products. [16]Individuals who have a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements in the past 3 months or will ingest those foods during the test period. [17]Individuals with probable seasonal allergy, such as pollinosis, during the test period. [18]Individuals whose life style will change during the test period. [19]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. [20]Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months. [21]Individuals who are or whose family is an employee of a health food, functional food, or cosmetic company. [22]Individuals judged inappropriate for the study by the principal. (1)Only male subjects. (2)Only female subjects.
Target sample size	28

Research contact person
Name of lead principal investigator	Mitsuhiro Sugimoto
Organization	Otsubokai Medical Corporation Tohto Bunkyo Hospital
Division name	Head
Address	3-5-7 Yushima Bunkyo-ku Tokyo 113-0034, JAPAN
TEL	+81-3-3831-2181
Email	info@tes-h.co.jp

Public contact
Name of contact person	Ryoma Shimizu
Organization	TES Holdings Co., Ltd.
Division name	Administrative Department of Clinical Trials
Address	6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN
TEL	+81-3-6801-8480
Homepage URL
Email	r.shimizu@tes-h.co.jp

Sponsor
Institute	TES Holdings Co., Ltd.
Institute
Department

Funding Source
Organization	Asahi Group Holdings, Ltd.
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

Other administrative information
Date of disclosure of the study information	2018 Year 06 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 05 Month 07 Day
Anticipated trial start date	2018 Year 06 Month 09 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	2018 Year 06 Month 08 Day
Last modified on	2018 Year 12 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037214