UMIN-CTR Clinical Trial

Basic information
Public title	Effect of the Test Food on Stress, Fatigue, Sleeping and Voiding.
Acronym	Effect of the Test Food on Stress, Fatigue, Sleeping and Voiding.
Scientific Title	Effect of the Test Food on Stress, Fatigue, Sleeping and Voiding.
Scientific Title:Acronym	Effect of the Test Food on Stress, Fatigue, Sleeping and 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 stress, fatigue, sleeping and voiding.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	[1]Indexes on stress and fatigue and indexes on sleeping (Japanese Translation of Profile of Mood States, VAS and Pittsburgh Sleep Quality Index [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]).
Key secondary outcomes	*Secondary outcomes [1]Indexes on physical condition (King's HealthQuestionnaire [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]Voiding diary (From the first day of ingestion of a test material to the last day of the test). *Safety [1]Blood pressure, pulsation (Screening, Day 14 of Observation Period I, Day 14 of Observation Period II). [2]Weight, body fat percentage, BMI (Screening, Day 14 of Observation Period I, Day 14 of Observation Period II). [3]Doctor's questions (Screening, Day 14 of Observation Period I, Day 14 of Observation Period II). [4]Subject's diary (From three days ago of ingestion of a test material to the last day of the test).

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	Food
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 10-14 times and who wake up to urinate during asleep is more than 3 time/weeks. [4]Individuals who have poor sleep quality, stress and fatigue because they wake up in the midnight (nocturnal awakening), wake up early in the morning (early morning awakening), do not feel well asleep (impaired sleep disorder). [5]Individuals whose lights-out and weak-up time is regular, land time of sleeping is over 5 hours. [6]Individuals who have no habit of taking alcohol. [7]Individuals who can measure and record urination volume during the observation period [8]Individuals whose written informed consent has been obtained. [9]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 who can not prohibit alcohol intake during the observation period. [13]Individuals who are sensitive to a test product or other foods, and medical products. [14]Individuals who have a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements in the past 1 months or will ingest those foods during the test period. [15]Individuals with probable seasonal allergy, such as pollinosis, during the test period. [16]Individuals whose life style will change during the test period. [17]Individuals who are pregnant, nursing or possibly pregnant. [18]Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months. [19]Individuals who are or whose family is an employee of a health food, functional food, or cosmetic company. [20]Individuals judged inappropriate for the study by the principal. (1)Only male subjects. (2)Only female subjects.
Target sample size	24

Research contact person
Name of lead principal investigator	1st name Takahiro Middle name Last name Ono
Organization	Ueno-Asagao Clinic
Division name	Head
Zip code	110-0015
Address	Kairaku Building 6F, 2-7-5, Higashiueno, Taito-ku, Tokyo, 110-0015, JAPAN
TEL	03-6240-1162
Email	info@ueno-asagao.clinic

Public contact
Name of contact person	1st name Ryoma Middle name Last name Shimizu
Organization	TES Holdings Co., Ltd.
Division name	Administrative Department of Clinical Trials
Zip code	110-0015
Address	Kairaku Building 6F, 2-7-5, Higashiueno, Taito-ku, Tokyo, 110-0015, 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 Quality & Innovations, Ltd.
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	Ueno-Asagao Clinic Ethical Review Committee
Address	Kairaku Building 6F, 2-7-5, Higashiueno, Taito-ku, Tokyo, 110-0015 JAPAN
Tel	+81-3-6240-1162
Email	jimukyoku@tes-h.co.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	2019 Year 05 Month 08 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	24
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	2019 Year 03 Month 11 Day
Date of IRB	2019 Year 03 Month 18 Day
Anticipated trial start date	2019 Year 05 Month 09 Day
Last follow-up date	2019 Year 06 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 04 Month 11 Day
Last modified on	2019 Year 09 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041354