None listed
Conditions
Interventions
Dietary Supplement : Subjects will be randomized to receive Test group or Placebo. Allotted human application test subjects should consume test food or control food for human application test once wit
Sponsors
Bundang CHA General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subjects who are adult men and women between 19~40 years of age 2) BMI of visit 1, is placed on 18.0 kg/m2~25 kg/m2 3) Experienced a hangover after drinking alcohol 4) A person whose ALDH2 genotype is wild or heterogeneous 5) Subjects who agree the particpation in the trial and submit informed and consent before the beginning of the trial.
Exclusion criteria
Exclusion criteria: 1) Subject currently being treated for cardiovascular system (hypertension, etc.), immune system, respiratory system, endocrine system (diabetes, etc.), gastrointestinal tract/liver and biliary system, kidney and urinary system, nervous system, musculoskeletal system, psychotropic, infectious diseases, and malignant tumors 2) Patients with peptic ulcer and reflux esophagitis based on visit 1 3) Subject who has a history of gastrointestinal diseases (e.g., Crohn's disease) or gastrointestinal surgeries (except for simple appendectomy or hernia surgery) that may affect the absorption of food for clinical trials 4) Alcohol use disorder or alcoholics as of visit 1 5) Subject who has drunken enough alcohol within 1 week of visit 1 to interfere with the test 6) Subject who has constantly administered drugs (such as antabuse-based drugs) or dietary supplements that are likely to affect alcohol metabolism, or drugs that pose a risk of gastrointestinal bleeding [warfarin, clopidogrel, aspirin, NSAIDs, and other antipyretic and anti-inflammatory drugs] 7) Subject who has administered medicines and health functional foods related to liver function improvement within 2 weeks of visit 2 8) Subject who has administered drugs that induce and inhibit drug metabolism enzymes (Barbiturates, Griseofulvin, Rifampin, Erythromycin, Isoniazid, Cimetidine, Omeprazole, etc.) within 1 month (30 days) based on visit 2 9) Subject who has administered antibiotics and intestinal control drugs within two weeks on the basis of visit 2 10) Subject who has ingested probiotics, prebiotics, and lactic acid bacteria products continuously (more than 4 times a week) within 2 weeks based on visit 2 11) Subject who is more than 2 time the upper limit normal Creatinine of clinical trial institution 12) Subject who is more than 3 times the upper limit normal AST (GOT) or ALT (GPT) of clinical institution 13) Anyone who is pregnant or breastfeeding or has a pregnancy plan for the duration of the test 14) Anyone who has participated or planned to participate in other clinical trials within the past one month 15) Subject who is sensitive or has an allergic reaction to food for human application testing 16) Anyone who is found to be inadequate by the tester for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Alcohol, Acetaldehyde concentration in blood and Dynamics parameters (dense by time, Cmax, AUC) | — |
Secondary
| Measure | Time frame |
|---|---|
| Alcohol, Acetaldehyde concentration in blood and Dynamics parameters(Tmax), AHS (Acute Hangover Scale), Time required to reach 0.03% or less of alcohol level in the blood | — |
Countries
Korea, Republic of
Contacts
Public ContactHyeonggyun Yoo
Bundang CHA General Hospital
Outcome results
None listed