Healthy Japanese
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 individuals 5. Individuals whose score of AIS is six or more and high at Scr among those who agreed to participate in this study and met the inclusion criteria 1~4, without meeting any of exclusion criteria
Exclusion criteria
Exclusion criteria: Individuals who 1. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. are currently undergoing treatment for cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 5. are taking medications (including herbal medicines) and supplements 6. are allergic to medicines and/or the test food related products 7. are pregnant, lactating, or planning to become pregnant during this study 8. have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate another study during this study 9. have mental health issues such as depression disorder, attention deficit/hyperactivity disorder (ADHD), or other issues 10. have irregular sleeping time or habit due to work such as a late-night shift 11. live with their infants less than one year old 12. sleep with their children (1 to 6 years old) 13. live with requiring long-term care persons 14. sleep with more than one person 15. have nocturia three times or more 16. drink to excess (average of more than about 20 g/day as pure 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. have irregular lifestyles (such as diet, exercise, and sleep) 18. are undergoing medical treatment for chronic fatigue syndrome or menopausal syndrome 19. work in physical labor such as transportation of heavy objects 20. are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured value of total score in the Athens Insomnia Scale (AIS) at the in-clinic examination after eight weeks of consumption (8w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The amount of change and rate of change from screening (at the in-clinic examination before consumption; Scr) of total AIS score at 8w 2. The measured value of total AIS score at home-based examination after four weeks of consumption (4w), and its amount and rate of change from Scr 3. The measured values of "sleepiness on rising," "initiation and maintenance of sleep," "frequent dreaming," "refreshing," "sleep length" and each item in the OSA sleep inventory MA version (OSA-MA), and total score in the Epworth Sleepiness Scale (ESS) at 4w and 8w, and the amount and rate of changes of them from Scr 4. The measured values of each item in the AIS and ESS at 4w and 8w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed