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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040411
Receipt No. R000045875
Scientific Title Evaluation study for intake of test food on improvement in stress and sleep
Date of disclosure of the study information 2020/05/15
Last modified on 2020/05/15

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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
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 Open public recruiting
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
2020 Year 05 Month 15 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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