None listed
Conditions
Interventions
Dietary Supplement : 1) Study Product (Hovenia Dulcis Complex)
Active Ingredient: Hovenia Dulcis fruit and Hovenia Dulcis fruit concentrate
Appearance and Dosage Form: Possesses a unique color and fla
the product is infused in alcohol andand taken together with alcohol
2) Placebo
Active Ingredient: Artemisia annua
Appearance and Dosage Form: Possesses a unique color and flavor, with no off-taste o
the product is infused in alcohol andand taken together with alcohol.
3) Crossover Design
Eligible participants will be randomized into Group A (Period 1: Hovenia dulcis fruit extract
Period 2: placebo) or Group B (Period 1: placebo
Period 2: Hovenia dulcis fruit extract) and will consume the investigational products accordingly.
Following Period 1, Period 2 will be conducted after a 7-day washout interval. All participants assig
Sponsors
Metro Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female subjects aged 19 to 40 years at the time of screening 2. Subjects with a body mass index (BMI) between 18.5 and 25.0 kg/m² 3. Subjects who have experienced a hangover after alcohol consumption 4. Subjects who consume alcohol at least once a month and whose usual alcohol intake per occasion is one bottle or more of soju (approximately 360 mL of 17% alcohol) 5. Subjects who have received a detailed explanation of the study, fully understood it, voluntarily agreed to participate, and provided written informed consent to comply with the study requirements
Exclusion criteria
Exclusion criteria: 1. Subjects who have consumed excessive amounts of alcohol (more than 21 drinks per week) within one week prior to the first intake of the test product 2. Subjects who have participated in another human application study or clinical trial and were administered an investigational product or drug within 30 days prior to the first intake of the test product (Participation in observational studies without drug or product administration — such as injection, ingestion, or insertion — is acceptable) 3. Subjects who have taken any medication expected to affect alcohol metabolism or clinical results within 30 days prior to the first intake of the test product (e.g., aspirin or other drugs with risk of gastrointestinal bleeding, antipyretic analgesics, anti-inflammatory agents, antibiotics, antihistamines, herbal medicines, oral steroids, hormonal preparations, barbiturates, or any drugs known to induce or inhibit drug-metabolizing enzymes) 4, Subjects who have consumed substances affecting gastric or hepatic function within 30 days prior to the first intake of the test product (e.g., milk thistle [silymarin], licorice extract, arginine, vitamin C, glutathione, probiotics, or prebiotics) 5. Subjects with severe acute or chronic diseases requiring treatment, such as cardiovascular or cerebrovascular diseases, metabolic disorders, alcohol metabolism disorders, diabetes mellitus, hypertension, cholelithiasis, pancreatitis, gout, active tuberculosis, gastrointestinal bleeding or surgery, hepatic or renal diseases (e.g., hepatitis B/C carriers, alcoholic liver disease), or disorders of the heart, lungs, gastrointestinal tract (e.g., gastric or duodenal ulcer), hepatobiliary system, muscles, nerves, psychiatric, endocrine, immune systems, malignancy, or any other significant medical condition 6. Pregnant or lactating subjects, and female subjects who do not agree to use adequate contraception* during the study period Adequate contraception includes intrauterine devices (IUD/IUS), vasectomy, tubal ligation, and barrier methods (male/female condoms, cervical caps, diaphragms, contraceptive sponges), used in combination with spermicide or another barrier method. 7. Subjects who rarely or never consume alcohol (less than once a month) or those who abstain from alcohol 8. Subjects currently taking or requiring the use of health supplements or prescription medications 9. Subjects with a known hypersensitivity or allergy to alcohol or any component of the test product, or with a clinically significant history of such reactions 10. Subjects who have consumed other hangover-relief products, drugs, or functional foods (including those from other manufacturers) within 30 days prior to the first intake of the test product, or those deemed unsuitable by the principal investigator 11. Subjects with gastrointestinal disorders or surgeries that may affect absorption of the test product (e.g., Crohn’s disease); however, appendectomy or hernia repair are not exclusionary 12. Subjects who have received psychiatric drug treatment within 5 years prior to the first intake of the test product 13. Subjects with a history or suspicion of alcohol or substance abuse 14. Subjects who have donated whole blood within 8 weeks or blood components within 2 weeks prior to the scheduled first intake of the test product 15. Subjects showing the following abnormal clinical laboratory test results: ? AST or ALT > 1.5 × upper limit of normal (ULN) ? Serum creatinine > 1.6 mg/dL ? Other clin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood Alcohol and Acetaldehyde Concentrations (Pre-alcohol intake and at 0.25, 0.5, 1, 2, 4, 6, and 15 hours after alcohol consumption);Cmax, Tmax, and iAUC of Alcohol and Acetaldehyde;Acute Hangover Symptom Questionnaire | — |
Secondary
| Measure | Time frame |
|---|---|
| Liver Function Markers (AST, ALT, ALP, GGT: measured pre-alcohol intake and at 15 hours post-alcohol consumption);Vital sign;Clinical laboratory examination;Adverse Event | — |
Countries
Korea, Republic of
Contacts
Public ContactSung Dae Kwon
Metro Hospital
Outcome results
None listed