UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055964 |
|---|---|
| Receipt number | R000063954 |
| Scientific Title | Investigation into the Impact of Alcohol Metabolism-Related Genotypes on Performance During Alcohol Consumption |
| Date of disclosure of the study information | 2024/10/28 |
| Last modified on | 2025/05/02 13:57:57 |
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Basic information
Public title
Investigation into the Impact of Alcohol Metabolism-Related Genotypes on Performance During Alcohol Consumption
Acronym
A Comparative Study on Performance in Relation to Alcohol Metabolism-Related Genotypes During Alcohol Consumption
Scientific Title
Investigation into the Impact of Alcohol Metabolism-Related Genotypes on Performance During Alcohol Consumption
Scientific Title:Acronym
A Comparative Study on Performance in Relation to Alcohol Metabolism-Related Genotypes During Alcohol Consumption
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To better understand human risk factors for preventing traffic accidents, we aim to conduct a study examining performance impairment associated with alcohol consumption. Given the genetic factors influencing alcohol tolerance, we will categorize participants based on genetic polymorphisms and investigate the differences in these impacts according to genotype.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
breath alcohol concentration
Key secondary outcomes
Cognitive Task Performance, Genotype,Cardiac Autonomic Nervous System (ANS) Indicators, Body Temperature, SpO2, Monitor (Pulse Rate, Oxygen Saturation, Perfusion Index), Questionnaires, Behavioral Analysis Data
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
An alcoholic beverage made by diluting 40% alcohol-by-volume vodka to 15% with water. Alcohol dose per body weight: 0.5 g/kg.
Interventions/Control_2
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
| 21 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Healthy men and women aged 21 years or older
2. BMI between 18.0 kg/m^2 and 30.0 kg/m^2
3. Individuals with a drinking frequency and quantity deemed appropriate for participation by the investigator and associated physicians, based on the results of the alcohol patch test and responses to a drinking habits questionnaire
4. Individuals who have previously consumed more than 50g of pure alcohol in a single day (equivalent to approximately two and a half 500 ml cans of beer or five glasses of wine) without experiencing significant health issues requiring medical intervention
5. Individuals who understand the study procedures and requirements, and can provide written consent to participate voluntarily
Key exclusion criteria
1. Individuals with alcohol allergies or alcohol intolerance.
2. Individuals with no drinking habits.
3. Individuals with a history or presence of cardiovascular diseases (e.g., heart failure, cerebrovascular disease, hypertension)
4. Individuals with a history or presence of kidney diseases (e.g., acute renal failure, glomerulonephritis, interstitial nephritis)
5. Individuals with a history or presence of liver diseases (e.g., viral hepatitis, alcoholic liver disease, drug-induced liver injury)
6. Individuals with alcohol dependence
7. Individuals taking medications are known to affect the sleep-wake cycle.
8. Individuals engaged in shift work, including night shifts.
9. Individuals who have traveled across time zones with a difference of four hours or more within the past month.
10. Individuals with sleep disorders
11. Individuals who regularly consume high levels of caffeine (e.g., five or more cups of coffee per day)
12. Other individuals deemed unsuitable by the investigator and associated physicians.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shigekazu |
| Middle name | |
| Last name | Higuchi |
Organization
Kyushu University
Division name
Faculty of Design
Zip code
815-0032
Address
4-9-1, Shiobaru, Minami-ku, Fukuoka
TEL
092-553-4523
higu-s@design.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Shigekazu |
| Middle name | |
| Last name | Higuchi |
Organization
Kyushu University
Division name
Faculty of Design
Zip code
815-0032
Address
4-9-1, Shiobaru, Minami-ku, Fukuoka
TEL
092-553-4523
Homepage URL
alcexp.higulab@gmail.com
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Honda R&D Co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Honda R&D Co., Ltd
Fukuoka Urazoe clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyushu University Certified Institutional Review Board for Clinical Trials
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka
Tel
092-642-5082
byskenkyu@jimu.kyushu-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
九州大学芸術工学研究院（福岡）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 28 | 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
98
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
| 2024 | Year | 09 | Month | 24 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 08 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 28 | Day |
Last follow-up date
| 2025 | Year | 05 | 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
| 2024 | Year | 10 | Month | 28 | Day |
Last modified on
| 2025 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063954
