Healthy Japanese subjects
Conditions
Interventions
Duration: 12 weeks Test food: Tablet containing sake lees enzyme Administration: Take five tablets with water between two hours and one hour before sleep *If you forget to take the test food, tak
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 judged as eligible to participate in the study by the physician according to the results of the Beck depression inventory (BDI-II) at Scr 6. Subjects who have low "sleepiness on rising" (Zc score) in the OSA-MA among those meeting No.1~5 of the inclusion criteria and not meeting the exclusion criteria at Scr (Screening of subjects who have "sleepiness on rising" (Zc score) in the OSA-MA will be conducted for each of the following stratum: "men aged 40 or more", "men aged less than 40", "women aged 40 or more", and "women aged less than 40")
Exclusion criteria
Exclusion criteria: Subjects (who/whose) 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 3. 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. use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily 5. currently 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 trial 8. 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. are judged as ineligible to participate in this study by the physician 10. live with their infants less than one year old 11. sleep with their children (1 to 6 years old) 12. live with and need to care for those in requiring long-term care 13. sleep with more than one person 14. sleeping time or habit is irregular due to work such as a late-night shift 15. have nocturia two times or more 16. have irregular lifestyles (such as inconstant eating time, insufficient sleeping time) 17. 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: 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)} 18. are undergoing treatment of insomnia or sleep disorder, or take sleep-inducing drugs or other medications 19. take food/beverage containing functional ingredients which may influence sleep quality (such as gamma-aminobutyric acid, crocetin, L-theanine, and lactic acid bacteria)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured value of "sleepiness on rising" in the OSA sleep inventory MA version (OSA-MA) at 12 weeks after consumption (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured value of "sleepiness on rising" in the OSA-MA at 4 and 8 weeks after consumption (4w, 8w) 2. The amount and rate of change of "sleepiness on rising" in the OSA-MA between screening (before consumption; Scr) and 4w, 8w, or 12w 3. The measured values of the "initiation and maintenance of sleep", "frequent dreaming", "refreshing", and "sleep length" in the OSA-MA at 4w, 8w, and 12w, and the amount and rate of changes of them from Scr 4. Each item in the OSA-MA at 4w, 8w, and 12w 5. The measured values of the total score, C1, C2, C3, C4, C5, C6, and C7 in the Pittsburgh Sleep Quality Index (PSQI-J) at 4w, 8w, and 12w, and the amount and rate of changes of them from Scr 6. Each item in the PSQI-J at 4w, 8w, and 12w 7. The measured value of the fatigue measured by visual analogue scale (VAS) at 12w, and the amount and rate of change of it from Scr 8. The measured values of the Total Mood Disturbance (TMD), Tension-Anxiety (TA), Depression-Dejection (DD), Anger-Hostility (AH), Vigor-Activity (VA), Fatigue-Inertia (FI), Confusion-Bewilderment (CB), and Friendliness (F) in the Profile of Mood States 2nd Edition (POMS2) at 12w, and the amount and rate of changes of them from Scr 9. Each item in the POMS2 at 12w 10. The measured values of the salivary amylase and tympanic membrane temperature at 12w, and the amount and rate of changes of them from Scr | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed