UMIN ID: UMIN000055964
Registered date:28/10/2024
Investigation into the Impact of Alcohol Metabolism-Related Genotypes on Performance During Alcohol Consumption
Basic Information
| Recruitment status | Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | Healthy Adults |
| Date of first enrollment | 2024/10/28 |
| Target sample size | 100 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | An alcoholic beverage made by diluting 40% alcohol-by-volume vodka to 15% with water. Alcohol dose per body weight: 0.5 g/kg. |
Outcome(s)
| Primary Outcome | breath alcohol concentration |
|---|---|
| Secondary Outcome | Cognitive Task Performance, Genotype,Cardiac Autonomic Nervous System (ANS) Indicators, Body Temperature, SpO2, Monitor (Pulse Rate, Oxygen Saturation, Perfusion Index), Questionnaires, Behavioral Analysis Data |
Key inclusion & exclusion criteria
| Age minimum | 21years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude 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. |
Related Information
| Primary Sponsor | Kyushu University |
|---|---|
| Secondary Sponsor | Honda R&D Co., Ltd Fukuoka Urazoe clinic |
| Source(s) of Monetary Support | Honda R&D Co., Ltd |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Shigekazu Higuchi |
| Address | 4-9-1, Shiobaru, Minami-ku, Fukuoka Japan 815-0032 |
| Telephone | 092-553-4523 |
| alcexp.higulab@gmail.com | |
| Affiliation | Kyushu University Faculty of Design |
| scientific contact | |
| Name | Shigekazu Higuchi |
| Address | 4-9-1, Shiobaru, Minami-ku, Fukuoka Japan |
| Telephone | 092-553-4523 |
| higu-s@design.kyushu-u.ac.jp | |
| Affiliation | Kyushu University Faculty of Design |