None listed
Conditions
Interventions
Pre-inoculate with citrate-containing foods 30 minutes before taking alcohol.
Pre-inoculation with placebo food 30 minutes before taking alcohol.
Sponsors
LLC.okutoeru Nihon Pharmaceutical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Japanese adult males and females 2) Age 20 years or older at the time of consent intake 3) Those with drinking habits 4) Those who have understood the purpose and content of the study and have given their consent. 5) Those who have been judged to have no problem participating in the study
Exclusion criteria
Exclusion criteria: 1) Persons who are intolerant to alcohol 2) Those who are regularly using medicines, food for specified health uses, functional foods, health foods, etc. that may affect the study. 3) Those who are currently participating in other human trials as study subjects, or within 4 weeks of the end of the trial in which they participated. 4) Those with positive test results for hepatitis B, hepatitis C, HIV, or human T-cell leukemia virus. 5) Those who have a history of drug allergy or food allergy. 6) Those who fall under any of the following categories Those with heart, liver, or kidney disease (including complications from other diseases) 7) Those who have other problems with participation. 8) Those who are pregnant, lactating, or plan to become pregnant during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of efficacy: blood alcohol concentration , area under the blood concentration time curve (AUC) | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of safety: adverse events | — |
Countries
Japan
Contacts
Public ContactYoshihiro Iwahori
LLC.okutoeru headquarters
Outcome results
None listed