Effect of Daily Ingestion of test food on improving Sleep Quality and Stress: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study
- Conditions
- Healthy Adult
- Registration Number
- JPRN-UMIN000044813
- Lead Sponsor
- Hokkaido Information University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 90
Not provided
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, benign prostatic hypertrophy, overactive bladder, hyperlipidemia and/or diabetes, etc. 2) The OABSS score of Q3 >=2, and the total score >= 3. 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 take antihypertensive agents. 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 take medicine and/or functional foods which would affect sleep and/or stress 4 days or more per week. 13) Heavy smokers, alcohol addicts and/or subjects with disordered lifestyle. 14) Subjects whose lifestyle is expected to change. 15) Subjects who live with infants. 16) Subjects who may be awakened at night for care. 17) 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 the current study. 18) Pregnant or lactating women or women who expect to be pregnant. 19) Subjects who currently participate in other clinical trials, or participated within the last 4 wks prior to the current study. 20) Any other medical and/or health reasons unfavorable to participation in the current study, as judged by the principal investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method