Healthy Japanese subjects
Conditions
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 5. Subjects who are concerned about their sleep quality 6. Subjects who are judged as eligible to participate in the study by the physician 7. Subjects whose the average of each score in the OSA-MA are relatively low at screening (before consumption; Scr)
Exclusion criteria
Exclusion criteria: Subjects 1. who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. who 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. who are currently undergoing treatment of insomnia or sleep disorder 5. who are judged as depressive tendency by total score of Beck Depression Inventory-II (BDI2) at Scr 6. who take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage in daily use 7. who currently taking medications (including herbal medicines) and supplements 8. who are allergic to medicines and/or the test food related products 9. who live with their infants less than one year old 10. who co-sleep with their children (one to six years old) 11. who live with requiring long-term care persons 12. who share the bed with more than one person 13. whose sleeping time or habit is irregular due to working a late-night shift 14. whose dinner time is extremely irregular 15. who have nocturia three times or more 16. who 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: 1 go of sake or about 1.5 glasses of wine, 90 mL: half-go with shochu, 60 mL: a glass of whiskey brandy (double)} 17. who are pregnant, lactation, or planning to become pregnant 18. who suffer from COVID-19 19. 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 20. who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| "Sleepiness on rising" in the OSA sleep inventory MA version (OSA-MA) at 12 weeks after consumption (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| "Initiation and maintenance of sleep", "frequent dreaming", "refreshing", "sleep length", and each item in the OSA-MA at 12w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed