UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024808 |
|---|---|
| Receipt number | 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 11:07:56 |
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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
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
info@tes-h.co.jp
Sponsor or person
Institute
Otsuka Pharmaceutical Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028535
