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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024808
Receipt No. R000028535
Scientific Title An exploratory study for examining the effects of PE on relaxation and stress in healthy adults: A Randomized, Double-blind, Placebo-controlled, Crossover Study.
Date of disclosure of the study information 2017/12/18
Last modified on 2018/02/22

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Basic information
Public title An exploratory study for examining the effects of PE on relaxation and stress in healthy adults: A Randomized, Double-blind, Placebo-controlled, Crossover Study.
Acronym The effects of PE on relaxation and stress
Scientific Title An exploratory study for examining the effects of PE on relaxation and stress in healthy adults: A Randomized, Double-blind, Placebo-controlled, Crossover Study.
Scientific Title:Acronym The effects of PE on relaxation and stress
Region
Japan

Condition
Condition None
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effects of PE on relaxation and stress.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Questionnaire of relaxation/stress
Key secondary outcomes

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 Intake of test food (PE) for a week, then intake of placebo for a week after wash-out period.
Interventions/Control_2 Intake of placebo for a week, then intake of test food (PE) for a week after wash-out period.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Healthy males and females aged 20 years old or more
Key exclusion criteria 1)Subjects who have allergic reaction to drug and food
2)Subjects who have a severe past medical history, acute infection, or mental disorder
3)Subjects who are heavy smokers (more than 20 cigarettes per day)
4) Subjects who are alcohol addicts
5)Subjects who have an extremely irregular eating pattern and work the shift or the graveyard shift
6)Subjects who are pregnant, lactating or expected to be pregnant during the study
7)Subjects who regularly take medicine, food for specified health uses, and/or health food which would affect the result of the study
8)Subjects who are participating in other clinical trials or have participated in other clinical trials within 4 weeks prior to the study
9)Subjects who are judged as unsuitable for the study by the principal investigator for other reasons
Target sample size 24

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shoichiro Inoue
Organization Otsuka Pharmaceutical Co., Ltd.
Division name Otsu Nutraceuticals Research Institute
Zip code
Address 3-31-13 Saigawa, Otsu, Shiga 520-0002, Japan
TEL 077-521-8835
Email Inoue.Shoichiro@otsuka.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshiyasu Tamura
Organization TES Holdings Co., Ltd.
Division name Division of Clinical Trial, Department of Development for Clinical Trials
Zip code
Address 6F University of Tokyo Entrepreneur Plaza, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan
TEL 03-6801-8480
Homepage URL
Email info@tes-h.co.jp

Sponsor
Institute Otsuka Pharmaceutical Co., Ltd.
Institute
Department

Funding Source
Organization Otsuka Pharmaceutical Co., 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
Address
Tel
Email

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
2017 Year 12 Month 18 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 Completed
Date of protocol fixation
2016 Year 11 Month 07 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 11 Month 11 Day
Last modified on
2018 Year 02 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028535

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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