Healthy Adult
Conditions
Sponsors
Hokkaido Information University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects who agree to participate in this study with a written informed consent. 2. Japanese males and females between 20 and 65 years old at the time of screening test. 3. Subjects with a total score of 6 or more on the Pittsburgh sleep quality index at the time of screening test.
Exclusion criteria
Exclusion criteria: 1. Subjects who are under physician's advice, treatment, and/or medication for insomnia, depression, Parkinson's disease, mood disorder, sleep apnea syndrome, nocturnal polyuria, prostatic hypertrophy, overactive bladder, hypertension, dyslipidemia and/or diabetes, etc. 2. Subjects who frequently go to the toilet at night. 3. Subjects with suspected sleep apnea syndrome. 4. Subjects who take medicines, herbs, and/or supplements that reducing blood sugar, inhibiting blood clotting and/or platelet aggregation. 5. Subjects who use pacemakers and/or defibrillators. 6. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities. 7. Subjects with major surgical history relevant to the digestive system. 8. Subjects with unusually high and/or low blood pressure, abnormal physical data and/or abnormal hematological data. 9. Subjects with severe anemia. 10. Pre- or post-menopausal women complaining of obvious physical changes. 11. Subjects who are at risk of having allergic reactions to drugs and/or foods. 12. Subjects who cannot abstain from taking medicine and/or functional foods which would affect sleep and/or stress during this study. 13. Heavy smokers, alcohol addicts and/or subjects with disordered lifestyle. 14. Subjects whose lifestyle is expected to change. 15. Subjects who may be awakened at night by those who live together, etc. 16. Subjects who donated either 400 ml whole blood within 16 wks (women), 12 wks (men), 200 ml whole blood within 4 wks, or blood components within 2 wks, prior to this study. 17. Pregnant or lactating women or women who expect to be pregnant. 18. Subjects who currently participate in other clinical trials, or participated within the last 4 wks prior to this study. 19. Any other medical and/or health reasons unfavorable to participation in the current study, as judged by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleep questionnaire | — |
Secondary
| Measure | Time frame |
|---|---|
| Sleep and stress questionnaires, objective evaluation (instrument measurement) of sleep and stress, body composition, blood lipids, etc. | — |
Countries
Japan
Contacts
Public ContactNaoyuki HONMA
Hokkaido Information University Health Information Science Center
Outcome results
None listed