Healthy Japanese subjects
Conditions
Interventions
Period I. Powder containing rice bran extract Period II. Powder without rice bran extract * The intervention sequence is from Period I to Period II, and each food is single ingestion. * Take 1 pa
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy subjects 2. Japanese adult subjects 3. Subjects who have a low tolerance of alcohol 4. Subjects who are judged as eligible to participate in the study by the physician
Exclusion criteria
Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily 5. Currently taking medicines (include herbal medicines) and supplements 6. Subjects who are allergic to medicines and/or the test food related products, particularly rice bran 7. Subjects who are not able to drink water diluted whisky 8. Subjects who drink alcoholic beverages to excess {Average amount of alcohol intake is approximately 60 g per day converted into absolute alcohol (approximately 540 mL of Japanese sake, 3 cans (500 mL/can) of beer, or 300 mL of distilled spirits)} 9. Subjects who are pregnant, lactation, or planning to become pregnant 10. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to enroll in anther clinical trial during trial period 11. Subjects who are ineligibility to participate in the study based on the evaluation of the principal physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incremental area under curve (IAUC) of the blood acetaldehyde levels * Take blood samples before drinking alcohol and at 30, 60, 120, and 180 minutes after intake (total 5 times). * Assess the IAUC between before drinking alcohol and 180 minutes after intake. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The maximum blood concentration (Cmax) of the blood acetaldehyde levels 2. Blood acetaldehyde levels 3. IAUC of the blood ethanol levels 4. Cmax of the blood ethanol levels 5. Blood ethanol levels 6. Subjective symptoms (The Likert scale method) *1-5 Take blood samples before drinking alcohol and at 30, 60, 120, and 180 minutes after intake (total 5 times). *1, 4 Assess the Cmax between before drinking alcohol and 180 minutes after intake. *2, 5 Assess the blood triglyceride levels of each measuring point between before drinking alcohol and 180 minutes after intake. *3 Assess the IAUC between before drinking alcohol and 180 minutes after intake. *6 Fill in the questionnaire once at 180 minutes after drinking alcohol. | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed