Healthy Japanese subjects
Conditions
Interventions
Duration: 12 weeks Test food: Capsule containing black soybean polyphenols Administration: Take one capsule with water after dinner once daily *If you forget to take the test food, take it as soo
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. Subjects aged 30 or more and 65 or less 4. Healthy subjects 5. Subjects who are dissatisfied with their subjective fatigue upon waking and sleep quality (such as short sleep time, difficulty falling asleep, difficulty sleeping soundly, dreaming, and persistent fatigue) in daily life 6. 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 7. Subjects who have low "sleepiness on rising" score in the OSA-MA among those meeting 1. ~ 6. and not meeting the exclusion criteria at Scr
Exclusion criteria
Exclusion criteria: Subjects 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 3. are 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. are currently taking medications (including herbal medicines) and supplements 6. are allergic to medicines and/or the test food related products (particularly, soybeans, pollen, or milk) 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. have irregular sleeping time or habit is 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. 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 currently undergoing treatment of insomnia or sleep disorder 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 values 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 The below items (No. 3~4) at 4w, 8w, and 12w, and the amount and rate of changes of them from Scr will be measured 3."Initiation and maintenance of sleep", "frequent dreaming", "refreshing", "sleep length", and each item in the OSA-MA 4.Each item in an original questionnaire The below items (No. 5~9) at 12w, and the amount and rate of changes of them from Scr will be measured 5.Total score, C1, C2, C3, C4, C5, C6, C7, and each item in the Pittsburgh Sleep Quality Index (PSQI-J) 6.Total Mood Disturbance (TMD), Tension-Anxiety (TA), Depression-Dejection (DD), Anger-Hostility (AH), Vigor-Activity (VA), Fatigue-Inertia (FI), Confusion-Bewilderment (CB), Friendliness (F), and each item in the Profile of Mood States 2nd Edition (POMS2) 7.Sleep score, sleep onset, sleep offset, midpoint of sleep, time in bed after sleep offset, sleep onset latency, StageR latency, NotScored total time, N1 total time, N2 total time, N3 total time, rapid eye moving (REM) total time, total sleep time (TST), wake time after sleep onset (WASO), sleep efficiency[%total recording time (TRT)], percentage of N1[%TST], percentage of N2[%TST], percentage of N3[%TST], and percentage of REM[%TST] in the sleep test 8.Blood flow and palmar surface temperature (with cold water load)* *Assessment items: The measured values at each time point, area under the curve (AUC) from immediately after load, and the amount of changes from before and immediately after load to each time point respectively Time points: Before load, immediately after load, 5, 10, 20, and 30 minutes after load 9.Oxidative stress markers {8-hydroxy-2'-deoxyguanosine (8-OHdG), thiobarbituric acid reactive sub | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed