UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039213 |
|---|---|
| Receipt number | R000044724 |
| 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 in elderly healthy subjects.- |
| Date of disclosure of the study information | 2020/01/21 |
| Last modified on | 2020/06/20 21:38:15 |
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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 in elderly healthy subjects.-
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 in elderly healthy subjects.-
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) in elderly healthy subjects
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
drinking 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
| 40 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male
Key inclusion criteria
1. BMI 18<= , <30.0 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 | Keiko |
| Middle name | |
| Last name | Matsuura |
Organization
Oita University Faculty of Medicine
Division name
Department of Biomedicine
Zip code
879-5593
Address
idaigaoka-1, Hasama-machi, Yufu-city, Oita
TEL
097-586-5608
matsuura@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Matsuura |
Organization
Oita University Faculty of Medicine
Division name
Department of Biomedicine
Zip code
879-5593
Address
idaigaoka-1, Hasama-machi, Yufu-city, Oita
TEL
097-586-5608
Homepage URL
matsuura@oita-u.ac.jp
Sponsor or person
Institute
Oita University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Science 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
Oita University Faculty of Medicine
Address
idaigaoka-1, Hasama-machi, Yufu-city, Oita
Tel
097-586-6163
gcrcjimu@oita-u.ac.jp
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 | 01 | Month | 21 | 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
| 2019 | Year | 12 | Month | 19 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 21 | Day |
Last follow-up date
| 2021 | Year | 03 | 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 | 01 | Month | 21 | Day |
Last modified on
| 2020 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044724
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
