Healthy Japanese adults
Conditions
Interventions
I. Active beverage II. Positive control beverage 1 III. Positive control beverage 2 IV. Placebo beverage *The intervention sequence is I-IV, and each beverage is single dose *Refrigerate the test
Sponsors
ORTHOMEDICO Inc.
Seishin-kai Medical Association Inc, Takara Medical Clinic.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese adults 2. Those who is able to drink whisky (alcohol: 18%) 3. Those who have a low tolerance of alcohol 4. Those who are considered as appropriate for the study by the physician 5. The area under the blood ethanol concentration-time curve (TAUC) is relatively large
Exclusion criteria
Exclusion criteria: 1. At least one previous medical history or under the treatment of malignant tumor, heart failure or myocardial infarction 2. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases 3. Those who use or take "Foods for Specified Health Uses" and "Foods with Functional Claims" in daily 4. Currently taking medicines and/or herbal medicines 5. Those who are allergic to medicines and/or the test food related products 6. Those who are pregnant, breast-feeding, and plan to become a pregnant 7. Those who had participated another clinical test for three months when you signed the informed consent form for this trial 8. Others considered as inappropriate for the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Blood ethanol concentration *Take blood samples before drinking alcohol and at 30, 60, 120, and 180 minutes after *Implement after each single-dose (total 4 times) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Blood acetaldehyde concentration * Take blood samples before drinking alcohol and at 30, 60, 120, and 180 minutes after *Implement after each single-dose (total 4 times) 2. Questionnaire of subjective symptoms (The Likert scale method) *Fill in the questionnaire 180 minutes after drinking alcohol *Implement after each single-dose (total 4 times) | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed