UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	An exploratory study for examining the effects of PE on relaxation and stress in healthy adults: A Randomized, Double-blind, Placebo-controlled, Crossover Study.
Title of the study (Brief title)	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	Shoichiro Inoue
Organization	Otsuka Pharmaceutical Co., Ltd.
Division name	Otsu Nutraceuticals Research Institute
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	Toshiyasu Tamura
Organization	TES Holdings Co., Ltd.
Division name	Division of Clinical Trial, Department of Development for Clinical Trials
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 11 Month 07 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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