Healthy adults
Conditions
Sponsors
Morinaga & Co.,Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Healthy males and females aged over 20 to under 65 when informed consent. (2)Subjects who can take 25g of alcohol on an empty stomach. (approximate amount: 1 large bottle of beer (633mL), 1.3 go of sake) (3)Subjects who can drink 125 mL of shochu with 25% alcohol by on the rocks. (4)Subjects who can tolerate repeated blood sampling. (5)Subjects who have received enough explanation and understood about this study, and who can obtain informed consent documents.
Exclusion criteria
Exclusion criteria: (1)Subjects infected by hepatitis virus. Subjects who... (2) had or suspected infectious disease such as COVID-19, or who had close contact with a patient. (3) cannot drink alcohol at all. (4) showed strong positive reaction in patch test of alcohol. (5)Subjects are aware of losing control due to drinking alcohol (entanglement, anger, yelling,etc.) (6) intake excessive alcohol. (Those who daily consume average more than about 60g of pure alcohol) (7)Who weigh 45 kg > or 90 kg <. (8)have current medical history or past medical history of diabetes.(9)constantly use medicines that may affect test results.Those who taking health foods and supplements daily, and those who may take or take them during the test period.(10)have current medical history or past medical history of serious disease in heart, liver, kidney, digestive organ.(11)are planning some kind of treatment during the study period. (12)Females who are pregnant or could become pregnant, and who are lactating.(13)Subjects who have medicine, milk or gelatin allergy. Subjects who (14)participated clinical trial within 4 weeks prior to the current study and/or who have planning to participate other clinical tests.(15)donated over 200mL blood and/or blood components within the last one month to the current study. (16)Males who donated over 400mL blood and/or blood components within the last 3 mos. to the current study.(17)Females who donated over 400mL blood and/or blood components within the last 4 mos. to the current study.(18)Males who exceed 1200 mL of blood when the planned total blood sampling volume of the study is added to the blood sampling volume from 12 mos. before the start of the study.(19)Females who exceed 800 mL of blood when the planned total blood sampling volume of the study is added to the blood sampling volume from 12 mos. before the start of the study.(20)Subjects who were judged ineligible for enrollment in the study by the principal investigator or sub-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood acetaldehyde concentration. | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood ethanol concentration,Breath ethanol concentration,VAS questionnaire about drinking and sense,Blood glucose concentration. | — |
Countries
Japan
Contacts
Public ContactHiroyuki Inagaki
Morinaga & Co.,Ltd Health Science and Research Center, R&D institute
Outcome results
None listed