Healthy Japanese subjects
Conditions
Interventions
<
Duration>
Single ingestion (one term) <
Test beverage>
Active beverage: Beverage containing functional ingredients derived from sake Placebo beverage: Beverage not containing functional ingredients derived from sake <
Load beverage>
At screening (before consumption
Scr), take one load beverage with 200 mL of water within five minutes. At the main examination, take one active beverage and four placebo beverages with 200 mL of water. Take all test beverages withi
Active beverage: Beverage containing functional ingredients derived from sake <
At Scr, take one load beverage with 200 mL of water within five minutes. At the main examination, take five active beverages with 200 mL of water. Take all test beverages within five minutes of start
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy subjects
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. Subjects currently undergoing treatment for any of the following chronic diseases: 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," or "Foods with Functional Claims" in daily 5. Subjects who are currently taking medications (including herbal medicines) and supplements 6. Subjects who are allergic to medicines and/or the test beverage related products 7. Subjects who are pregnant, lactating, or planning to become pregnant during this trial 8. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 9. Subjects who are judged as ineligible to participate in this study by the physician 10. Subjects who usually drink sake 11. Subjects who usually drink mirin / intentionally use a lot of mirin in dishes 12. Subjects who usually drink to excess (average of more than about 20 g/day as absolute alcohol intake) {500 mL: a medium bottle of beer or about 1.5 cans of canned chu-hi, 180 mL: about 1.5 glasses of wine, 90 mL: half-go with shochu, 60 mL: a glass of whiskey brandy (double)} 13. Subjects who will be unable to collect urine from the day of ingestion of the test beverage to the next day
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The incremental area under the curve (IAUC) of blood glucose, insulin, and ethanol after the single ingestion of the test beverage 2. The measured value of blood glucose, insulin, and ethanol 30, 60, 90, and 120 minutes after the single ingestion of the test beverage 3. The amount of functional ingredients derived from sake released into the urine in 24 hours from the single ingestion of the test beverage | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed