None listed
Conditions
Interventions
Dietary Supplement : The study design is a Double-blind, Randomized, Cross-over Clinical Trial.
Subjects will visit a total of three times, and at each visit, subjects will consume the allocated test
Sponsors
Handok
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults aged 20 to 50 who can consume 1 to 2 bottles of soju and who has had a hangover after drinking 2. A person with an AUDIT-K drinking habit survey score of 19 or lower, classified as either normal or hazardous drinkers. 3. A person who voluntarily agrees to participate in the study and signs an informed consent form
Exclusion criteria
Exclusion criteria: 1. A person with a BMI of less than 18.5 kg/? or greater than 30.0 kg/?. 2. A person with systolic blood pressure of 160mmHg or higher, or diastolic blood pressure of 100mmHg or higher (if diagnosed with hypertension, blood pressure while on medication must be confirmed). 3. A person with fasting blood glucose of 126mg/dL or higher, diagnosed with diabetes, or taking oral hypoglycemic agents or insulin. 4. A person with renal dysfunction (Creatinine levels 1.5 times above the upper normal limit) or liver dysfunction (AST, ALT levels 2.5 times above the upper normal limit). 5. A person who has engaged in excessive drinking within one week of the screening test, or plans to engage in excessive drinking during the study period (abstain from alcohol two days before hospitalization). 6. A person who typically consumes little to no alcohol (less than once a month) or abstains from alcohol. 7. A person diagnosed with liver diseases such as viral hepatitis, acute hepatitis, liver cancer, or cirrhosis. 8. A person with a history or current diagnosis of drug or alcohol addiction or mental illness. 9. A person diagnosed with acute or severe diseases (liver, kidney, heart, thyroid diseases, malignant tumors) or currently taking medication for these conditions. 10. A person diagnosed with gastrointestinal diseases such as chronic gastritis, peptic ulcer, Crohn's disease, or with a history of gastrointestinal surgery (excluding simple appendectomy or hernia surgery). 11. A person who has donated whole blood within two months or component blood within one month before the first administration, or received a transfusion within one month before the first dose. 12. A person who has experienced severe symptoms or side effects related to heart disease after drinking alcohol, deemed inappropriate by the researcher. 13. A person who has taken enzyme-inducing or inhibiting drugs, such as barbiturates, within one month before the initiation of the study. 14. A person taking aspirin or other medications that pose a risk of latent bleeding. 15. A person taking medications or health supplements that are judged to affect alcohol metabolism. 16. A person allergic or hypersensitive to the ingredients of the test product. 17. A person who participated in another clinical trial one month before participation in the study. 18. A person who pregnant or lactating. 19. A person who is illiterate or whose ability is limited. 20. A person deemed inappropriate by the principal investigator to participate in the research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood alcohol and acetaldehyde concentrations | — |
Secondary
| Measure | Time frame |
|---|---|
| Breath alcohol concentration ;Alcohol Hangover Symptoms Questionnaire | — |
Countries
Korea, Republic of
Contacts
Public ContactYeongtaek Hwang
Research Institute of Medical Nutrition
Outcome results
None listed