Healthy adults.
Conditions
Interventions
Duration: Eight weeks Test product: Flavonoid
Duration: Eight weeks Test product: Placebo
Sponsors
Toyo Sugar Refining Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy individuals 5. Individuals who are dissatisfied with their sleep quality 6. Individuals who are judged as eligible to participate in this study by the physician according to the results of the Beck depression inventory (BDI-II) at Scr 7. Individuals with low "sleepiness on rising" (Zc score) in the OSA sleep inventory MA version (OSA-MA) at Scr
Exclusion criteria
Exclusion criteria: 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction 2. Individuals who have a pacemaker or an implantable cardioverter defibrillator 3. Individuals who are 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. Individuals who are undergoing treatment of insomnia or sleep disorder 5. Individuals who have nocturia two times or more 6. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 7. Individuals who are taking or using medications (including herbal medicines) or supplements 8. Individuals who are allergic to medicines or foods related to the test product 9. Individuals who live with their infants less than one year old 10. Individuals who sleep with their children (one to six years old) 11. Individuals who live with and need to care for those in requiring long-term care 12. Individuals who sleep with more than one person 13. Individuals with irregular sleeping duration or patterns due to night shifts or similar work, or with irregular lifestyles 14. Individuals who currently smoke or began smoking cessation within three months before providing informed consent 15. Individuals who habitually drink >= 60 g/day of alcohol 16. Individuals who are pregnant, lactating, or planning to become pregnant during this study 17. Individuals who 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 18. Individuals who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured value of "sleepiness on rising" (Zc score) at four weeks after intervention (4w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured value of "sleepiness on rising" (Zc score) at two weeks after intervention (2w) 2. The change and percentage change from screening (Scr) of "sleepiness on rising" (Zc score) at 2w and 4w 3. The measured values of "initiation and maintenance of sleep" (Zc score), "frequent dreaming" (Zc score), "refreshing" (Zc score), "sleep length" (Zc score), and each item (Zc score) at 2w and 4w, as well as their changes and percentage changes from Scr 4. The measured value of total score in the Athens Insomnia Scale (AIS) at 2w and 4w, as well as its change and percentage change from Scr | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed