Effect of Daily Ingestion of Sea Buckthorn Juice on Sleep Quality: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study
- Conditions
- Healthy Adult
- Registration Number
- JPRN-UMIN000050444
- Lead Sponsor
- Hokkaido Information University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 20
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, overactive bladder, hypertension, dyslipidemia and/or diabetes, etc. 2.Subjects who regularly use medicines that inhibit blood clotting and/or gastric acid secretion. 3.Subjects who frequently go to the toilet at night. 4.Subjects with suspected sleep apnea syndrome. 5.Subjects whose lifestyle is expected to change. 6.Subjects who use pacemakers and/or defibrillators. 7.Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal, respiratory diseases, and/or affected with infectious diseases requiring reports to the authorities. 8.Subjects with major surgical history relevant to the digestive system. 9.Subjects with unusually high and/or low blood pressure, abnormal physical data and/or abnormal hematological data. 10.Subjects with severe anemia. 11.Post-menopausal women complaining of obvious physical changes, or subjects who are under physician's advice, treatment, and/or medication for menopausal symptoms. 12.Subjects who are at risk of having allergic reactions to drugs and/or foods especially based on milk, Asteraceae, Elaeagnaceae. 13.Subjects who regularly take medicine, functional foods which would affect sleep, fatigue, and/or frequent urination. 14.Subjects who regularly take sea buckthorn. 15.Heavy smokers, alcohol addicts and/or subjects with disordered lifestyle. 16.Subjects who donated either 400 ml whole blood within 16 wks, 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.Subjects who are ineligible due to physician's judgment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method OSA sleep inventory MA version after 4 weeks of ingestion.
- Secondary Outcome Measures
Name Time Method VAS questionnaire, The Brief Job Stress Questionnaire (Section B), Pittsburgh Sleep Quality Index, Overactive Bladder Symptom Score.