None listed
Conditions
Interventions
Others(hangover cure) : Subjects take 1 packet of test food or control food 30 minutes prior to drinking alcohol after completing standard meals at the institution on the day of the first period (Visi
Sponsors
FromBIO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Healthy adult men and women aged 19 to 40 years at the time of screening. 2) Those who have experienced a hangover after drinking alcohol within the past month. 3) Those with a body mass index (BMI) of 18.5 kg/m2 to less than 30.0 kg/m2. 4) Those who understand and are capable of complying with the test methods and procedures outlined in this human application study plan.
Exclusion criteria
Exclusion criteria: 1) Those with a clinically significant hypersensitivity to alcohol or a history of alcoholism. 2) Those with a history of alcoholism or excessive drinking (more than 21 drinks per week) within the week prior to taking the product for human application testing. 3) Those who rarely consume alcohol (less than once a month) or who abstain from alcohol. 4) Those who have taken dietary supplements or medications that may affect alcohol metabolism (e.g., aspirin and other medications with a risk of gastrointestinal bleeding, non-steroidal anti-inflammatory drugs, painkillers, antibiotics, herbal medicines, steroids, hormones, etc.) within 30 days prior to taking the product for human application testing. 5) Those who have taken medications or health functional foods (e.g., silymarin (milk thistle), licorice extract, etc.) deemed to affect the stomach and liver, including hangover relief products from other companies, within 30 days prior to taking the product for human application testing. 6) Those who have taken the product for human application testing on the first day of taking the product for human application testing. Those who have taken drugs that induce or inhibit drug-metabolizing enzymes (e.g., barbiturates) within the past 30 days. 7) Those with alcohol metabolism disorders, diabetes, hypertension, cholelithiasis, pancreatitis, gout, active tuberculosis, gastrointestinal bleeding or surgery, or kidney, liver, or liver disease (e.g., hepatitis B and C carriers, alcoholic liver disease), heart, lung, gastrointestinal, or nervous system disease. 8) Those with clinically significant acute or chronic cardiovascular (congestive heart failure, coronary artery disease, myocardial infarction, etc.), endocrine (uncontrolled hyperlipidemia, thyroid disease), respiratory (e.g., asthma), hepatobiliary, renal, urinary, nervous (central or peripheral), psychiatric, musculoskeletal, inflammatory, hematological, or oncological diseases requiring treatment. 9) Those with gastrointestinal diseases (e.g., Crohn's disease) or gastrointestinal surgery (except for simple appendectomy or (excluding hernia surgery) 10) Those with or undergoing treatment for a clinically significant gastrointestinal disease, such as peptic ulcer (gastric ulcer, duodenal ulcer, etc.) or reflux esophagitis. 11) Those who have participated in another human clinical trial within the past month (excluding observational studies that did not involve the administration of drugs or food (injection, ingestion, insertion, etc.)) or plan to participate in another clinical trial or human clinical trial during the period of this human clinical trial. 12) Pregnant or lactating women. 13) Those who exhibit the following results in diagnostic laboratory tests: ? AST, ALT > 3 times the upper limit of the reference range ? Serum Creatinine > 2.0 mg/dL 14) Those deemed unsuitable for study participation by the principal investigator due to diagnostic laboratory test results or other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood alcohol concentration;blood acetaldehyde concentration | — |
Secondary
| Measure | Time frame |
|---|---|
| superoxide dismutase;Hangover Self-Assessment Questionnaire | — |
Countries
Korea, Republic of
Contacts
Public ContactMoon Chul Lee
Bestian Seoul Hospital
Outcome results
None listed