UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050305 |
|---|---|
| Receipt number | R000057281 |
| Scientific Title | Investigation of the effect of water drinking on hangover symptoms |
| Date of disclosure of the study information | 2023/02/10 |
| Last modified on | 2024/02/12 14:51:16 |
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Basic information
Public title
Investigation of the effect of water drinking on hangover symptoms
Acronym
Effect of watet drinkings on hangovers
Scientific Title
Investigation of the effect of water drinking on hangover symptoms
Scientific Title:Acronym
Effect of watet drinkings on hangovers
Region
| Japan |
Condition
Condition
healthy subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The main objective of this study is to clarify whether or not the symptoms of hangover on the following day change, when a man drinks the amount of alcohol that causes a mild hangover while drinking a glass of water. We also investigate the dynamics of ethanol metabolism during heavy drinking. A secondary objective is to explore whether hangover symptoms are associated with polymorphisms in genes other than alcohol metabolism-related genes (ADH and ALDH).
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
subject symptoms related to alcohol intoxication (VAS)
psychomotor performance test (DSST)
Key secondary outcomes
pharmacokinetics of breath alcohol and acetaldehyde
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Drink only sake in the first test, and after an interval of at least 1week, drink sake and water in the second test
Interventions/Control_2
Drink sake and water in the first test, and after an interval of at least 1 week, drink sake and water in the second test
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
| 50 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Japanese healthy male
2) BMI between 18 and 30 kg/m2
3) No abnormal findings on laboratory and physician's examination
4) ALDH2 *1/*1 genotype
5) having history of alcohol consumption over 100g without serious health problem
6) capable to understand the study's methods and compliance requirements, and give written informed consent to participate in this study of his own will
Key exclusion criteria
1) having allergy or intolerance of alcohol
2) Existence or pre-existence of cardiovascular diseases
3) Existence or pre-existence of liver diseases
4) Existence or pre-existence of kidney diseases
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hiromitsu |
| Middle name | |
| Last name | Imai |
Organization
Oita University
Division name
Dept of Medical Ethics, Faculty of Medicine
Zip code
8795593
Address
1-1 Idaigaoka, Hasama, Yufu-city, Oita
TEL
097-586-5600
imaih@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiromitsu |
| Middle name | |
| Last name | Imai |
Organization
Oita University
Division name
Dept of Medical Ethics, Faculty of Medicine
Zip code
8795593
Address
1-1 Idaigaoka, Hasama, Yufu-city, Oita
TEL
097-586-5600
Homepage URL
imaih@oita-u.ac.jp
Sponsor or person
Institute
Oita University
Institute
Department
Personal name
Funding Source
Organization
Sanwa Laboratory
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Sanwa Laboratory
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Oita University Hospital, Clinical Trial Ethics Committee
Address
1-1 Idaigaoka, Hasama, 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
| 2023 | Year | 02 | Month | 10 | 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
| 2022 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 06 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 08 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 02 | Month | 10 | Day |
Last modified on
| 2024 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057281
