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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036015
Receipt No. R000041027
Scientific Title Clinical study for the metabolism of Japanese Shochu. -Sequential change of the exhalation concentration of alcohol, and psychomotor performance after intake of Shochu.-
Date of disclosure of the study information 2019/02/26
Last modified on 2019/08/28

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Basic information
Public title Clinical study for the metabolism of Japanese Shochu.
-Sequential change of the exhalation concentration of alcohol, and psychomotor performance after intake of Shochu.-
Acronym Clinical study for the metabolism of Japanese Shochu.
Scientific Title Clinical study for the metabolism of Japanese Shochu.
-Sequential change of the exhalation concentration of alcohol, and psychomotor performance after intake of Shochu.-
Scientific Title:Acronym Clinical study for the metabolism of Japanese Shochu.
Region
Japan

Condition
Condition healthy volunteer
Classification by specialty
Adult
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To evaluate the effect of genetic polymorphism of ALDH2 after taking Shochu (Japanese alcohol)
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Psychomotor performance
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 drinking Shochu
Interventions/Control_2 drining water
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
60 years-old >
Gender Male
Key inclusion criteria 1. BMI 18.5<= , <28.0 kg/m2
2. No abnormal findings in physical examination and laboratory test
3. Giving written informed conset
Key exclusion criteria 1. Having allergy for alcohol and/or intolerance for alcohol
2. Volume of alcohol consumption is over 15 units per week
3. Having history of any severe allergy
4. Having history of any drug abuse and/or alcohol abuse
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keiko Matsuura
Organization Oita University Faculty of Medicine
Division name Department of Biomedicine
Zip code
Address idaigaoka-1, Hasama-machi, Yufu-city, Oita
TEL 097-586-5608
Email matsuura@oita-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keiko Matsuura
Organization Oita University Faculty of Medicine
Division name Department of Biomedicine
Zip code
Address idaigaoka-1, Hasama-machi, Yufu-city, Oita
TEL 097-586-5608
Homepage URL
Email matsuura@oita-u.ac.jp

Sponsor
Institute Oita Unversity Faculty of Medicine
Institute
Department

Funding Source
Organization Japan Scince and Technology Agency
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2019 Year 02 Month 26 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 14
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 Preinitiation
Date of protocol fixation
2019 Year 01 Month 11 Day
Date of IRB
Anticipated trial start date
2019 Year 02 Month 26 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
2019 Year 02 Month 26 Day
Last modified on
2019 Year 08 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041027

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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