Healthy Adults
Conditions
Interventions
An alcoholic beverage made by diluting 40% alcohol-by-volume vodka to 15% with water. Alcohol dose per body weight: 0.5 g/kg.
Sponsors
Kyushu University
Honda R&
D Co., Ltd Fukuoka Urazoe clinic
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| breath alcohol concentration | — |
Secondary
| Measure | Time frame |
|---|---|
| Cognitive Task Performance, Genotype,Cardiac Autonomic Nervous System (ANS) Indicators, Body Temperature, SpO2, Monitor (Pulse Rate, Oxygen Saturation, Perfusion Index), Questionnaires, Behavioral Analysis Data | — |
Countries
Japan
Contacts
Public ContactShigekazu Higuchi
Kyushu University Faculty of Design
Outcome results
None listed