UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040411
Receipt number 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 2021/05/17 09:07:05

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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 or person

Institute

Shiba Palace Clinic



Institute

Department

Personal name



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

Value
https://center6.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