Healthy Japanese
Conditions
Sponsors
Yotsuba Milk Products Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy individuals 5. Individuals among those who provided informed consent, met inclusion criteria No. 1~4, and did not meet any of the exclusion criteria, whose AIS score is six or higher at screening
Exclusion criteria
Exclusion criteria: Individuals who 1. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction 2. have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. are currently undergoing treatment for any of the following chronic diseases: 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 or using medications (including herbal medicines) or supplements 6. are allergic to medicines or foods related to the test product 7. have mental health issues such as depression disorder, attention deficit/hyperactivity disorder (ADHD), or other issues 8. have irregular sleeping time or habit due to work such as a late-night shift 9. live with their infants less than one year old 10. sleep with their children (1 to 6 years old) 11. live with requiring long-term care persons 12. sleep with more than one person 13. have nocturia three times or more 14. drink to excess (average of more than about 20 g/day as pure alcohol intake) 15. have irregular lifestyles (such as diet, exercise, and sleep) 16. are undergoing medical treatment for chronic fatigue syndrome, menopausal syndrome, sleep apnea syndrome, or any other sleep disorders 17. work in physical labor such as transportation of heavy objects 18. are undergoing medical treatment or have a medical history of sleep disorder or sleep apnea syndrome 19. Individuals who are pregnant, lactating, or planning to become pregnant during this study 20. have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study 21. are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Measured value of the total score on the Athens Insomnia Scale (AIS) at eight weeks after the intervention (8w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change and percentage change in the total score on the AIS from screening to 8w 2. Measured value of the total score on the AIS at four weeks after the intervention (4w), as well as change and percentage change from screening 3. 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 the total score on the Epworth Sleepiness Scale (ESS) at 4w and 8w, as well as changes and percentage changes from screening 4. Individuals whose responses to each item of the AIS and the ESS improved by at least one grade at 4w and 8w compared with screening | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed