healthy subject
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 0.5g/kg (ideal body weight) of alcohol(25% alcohol by shochu) when stomach empty. Approximate amount is 117 mL to 138 mL for women of155 cm to 165 cm height, and 146 mL to 169 mL for men of 165 cm to 175 cm height. (3)Subjects who can drink approximate 13% alcohol. (4)Subjects who have a habit of spontaneous alcohol consumption at least twice a week and are aware frequent redness of the face, neck, etc. (5)Subjects who have received enough explanation and understood about this study, and who can obtain informed consent documents.
Exclusion criteria
Exclusion criteria: Subjects who (1)infected by hepatitis virus. (2)had or suspected infectious disease such as COVID-19, or who had close contact with a COVID-19 patient. (3)cannot drink alcohol at all. (4)showed strong positive reaction in patch test of alcohol. (5)aware of losing control due to drinking alcohol (entanglement, anger, yelling, crying, etc.) (6)intake excessive alcohol. (Those who daily consume average more than about 60g of pure alcohol) (7)weigh less than 45 kg or more than 90 kg. (8)have current medical history or past medical history of diabetes. (9)constantly use medicines that may affect test results. (cephem antibiotics such as Cefaclor, Cefotiam, Cefdinir, Anti-alcoholic drugs such as Disulfiram, Cyanamide etc.).Those taking health foods and supplements (turmeric, ornithine, etc.) 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)have allergies to medicines and foods (especially milk and gelatin). (14)participated clinical trial within 4-weeks prior to the current study and/or who have planning to participate the 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 three months to the current study. (17)Females who donated over 400mL blood and/or blood components within the last four months to the current study. (18)Males who exceed 1200 mL of blood sampling volume including this study within the last 12 months. (19)Females who exceed 800 mL of blood sampling volume including this study within the last 12 months. (20)were judged ineligible for enrollment in the study by the principal investigator or sub-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood ethanol concentration, Blood acetaldehyde concentration Expiration ethanol concentration, one-leg standing time with eyes closed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood glucose concentration, VAS questionnaire about drinking and sense. | — |
Countries
Japan
Contacts
Public ContactHiroyuki Inagaki
R&D Institute Morinaga & Co., Ltd. Health Science and Research Center
Outcome results
None listed