UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation study for intake of test food on improvement in stress and sleep
Acronym	Evaluation study for intake of test food on improvement in stress and sleep
Scientific Title	Evaluation study for intake of test food on improvement in stress and sleep
Scientific Title:Acronym	Evaluation study for intake of test food on improvement in stress and sleep
Region	Japan

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

Objectives
Narrative objectives1	To evaluate improvement in stress and sleep by taking the test food containing peptides derived from soybean
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	sleep EEG EGG heart rate POMS questionnaire STAI questionnaire VAS (before and after intake of the test food)
Key secondary outcomes	blood pressure cortisol in saliva OSA sleep questionnaire (before and after intake of the test food)

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	Intake the active food one time on the test date
Interventions/Control_2	Intake the placebo food one time on the test date
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	30 years-old <=
Age-upper limit	59 years-old >=
Gender	Male
Key inclusion criteria	1) Japanese males aged 30 to 59 years old 2) Subjects who take breakfast at 8-9 a.m. 3) Subjects who can be fasted until the end of the measurement (for around 8 hours) 4) Subjects who can perform tasks on tablets for 3-4 hours during the measurement 4) Subjects who can feel frustrated compared to their young days 6) Subjects who can not concentrate compared to their young days 4) Subjects who can not be clearheaded compared to their young days 8) Subjects who can not try their best compared to their young days 9) Subjects who can not be positive compared to their young days 10) Subjects who can not show their ability compared to their young days 11) Subjects who feel bored compared to their young days 12) Subjects who work on day time and have stable lifestyle (eating, sleeping, etc.) 13) Employees who work for 7-9 hours a day and 5 days a week 14) Subjects who sleep alone without any partners including pets 15) Healthy adults without any existing medical conditions
Key exclusion criteria	1) Subjects who are taking medicines that can affect the test result 2) Subjects who participated/ will participate in other clinical studies in the past 4 weeks. 3) Subjects who have night-time shift work. 4) Subjects who have plans of domestic/foreign travel during the test 5) Subjects who have unstable lifestyle 6) Subjects who have medical history including hey fever/migraine/orthopedic problems/chronic fatigue/circulatory disease 7) Subjects who have liver/kidny/heart/ disease 8) Subjects who have diabetes 9) Subjects who are allergic to the test food 10) Subjects who have smoking habit 11) Subjects who are supposed not to be proper by the investigator
Target sample size	8

Research contact person
Name of lead principal investigator	1st name Takashi Middle name Last name Koikeda
Organization	Shiba Palace Clinic
Division name	Chair
Zip code	105-0013
Address	DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
TEL	03-5408-1590
Email	jimukyoku@mail.souken-r.com

Public contact
Name of contact person	1st name Ko Middle name Last name Masuda
Organization	SOUKEN Co., Ltd
Division name	Management Division
Zip code	105-0013
Address	DaiwaA Hamamatsucho Bldg. 3F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
TEL	03-5408-1555
Homepage URL
Email	k_masuda@mail.souken-r.com

Sponsor
Institute	Shiba Palace Clinic
Institute
Department

Funding Source
Organization	UHA Mikakuto Co., Ltd.
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	User Life Science Co., Ltd. Ethics Review Committee
Address	372-3, Jinbo, Iizuka-City, Fukuoka, 820-0115, JAPAN
Tel	0948-82-3123
Email	keiwithmogu@gmail.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	2020 Year 05 Month 15 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	8
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 04 Month 22 Day
Date of IRB	2020 Year 05 Month 01 Day
Anticipated trial start date	2020 Year 05 Month 06 Day
Last follow-up date	2020 Year 07 Month 31 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 05 Month 15 Day
Last modified on	2021 Year 05 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000045875