None listed
Conditions
Interventions
Others(Health Functional Food) : Subjects who voluntarily signed the informed consent form for this human application trial will be evaluated at Visit 1 for eligibility based on inclusion and exclusio
Sponsors
Woorikidsplus Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects aged 19–40 years Subjects with a BMI between 18.5 and 25 kg/m² measured at Visit 1 Subjects with a history of hangover after alcohol consumption Subjects who consent to participate in the study before initiation and have signed the informed consent form (ICF)
Exclusion criteria
Exclusion criteria: Subjects with diabetes, hypertension, cholelithiasis, pancreatitis, gout, active tuberculosis, or a history of gastrointestinal bleeding or surgery, or renal, hepatic (including hepatitis B or C carriers, alcoholic liver disease), cardiac, pulmonary, gastrointestinal, neurological, or peptic ulcer (gastric or duodenal ulcer) diseases. Subjects with gastrointestinal diseases (e.g., Crohn’s disease) or gastrointestinal surgery that may affect the absorption of the test food for human application (excluding simple appendectomy or hernia repair). Subjects with a history of alcohol abuse, drug abuse, or alcohol metabolism disorders. Subjects currently taking medications or dietary supplements that may affect alcohol metabolism (e.g., Disulfiram), or drugs that increase the risk of gastrointestinal bleeding (e.g., Warfarin, Clopidogrel, Aspirin), or regular use of antipyretic, analgesic, or anti-inflammatory drugs. Subjects who have used liver function-improving agents (e.g., UDCA, Silymarin) or health functional foods (e.g., milk thistle extract, Hovenia dulcis extract powder), or hangover-relief products within 2 weeks prior to Visit 1. Subjects who have used drug-metabolizing enzyme inducers or inhibitors (e.g., Barbiturates, Griseofulvin, Rifampin, Erythromycin, Isoniazid, Cimetidine, Omeprazole) within 1 month (30 days) prior to Visit 1. Subjects whose alcohol-metabolizing genotype at Visit 1 is homozygous ALDH2*2/*2 (AA type). Subjects who are heavy smokers (= 20 cigarettes per day). Subjects who have consumed alcohol within 1 week prior to Visit 1 in a manner that may interfere with the study. Subjects who rarely consume alcohol (= once per month) or are abstainers. Subjects with AST (GOT) or ALT (GPT) levels = 3 times the upper limit of normal at the study site. Subjects deemed unsuitable by the investigator based on clinical laboratory tests, vital signs, or other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AHS(Acute Hangover Scale);Blood alcohol and acetaldehyde concentrations(time-course, Cmax, Tmax, AUC, iAUC) | — |
Secondary
| Measure | Time frame |
|---|---|
| AE(Adverse Events);Clinical laboratory tests(hematology, blood chemistry, urinalysis);Vital signs (blood pressure, pulse rate, body temperature) | — |
Countries
Korea, Republic of
Contacts
Public ContactSung-Bum Lee
Soon Chun Hyang University Hospital Bucheon
Outcome results
None listed