Confirmation test on sleep and basal metabolism by ingesting rose hip extract
- Conditions
- Healthy adult male
- Registration Number
- JPRN-UMIN000035305
- Lead Sponsor
- niversity of Tsukuba
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Male
- Target Recruitment
- 10
Not provided
1) Subjects who systolic blood pressure is 90 mmHg or less 2) Subject who participating in other test or within 4 weeks after participating in another test 3) Subjects who falls under any of the following items. a) Subjects who having a disease in the heart, liver, kidney, stomach (gastric acid secretion, gastric ulcer) (including complications of other diseases) b) Subjects with a history of cardiovascular disease c) Subjects who develop diabetes d) Subjects who are allergic to the test food 4) Claustrophobic subjects 5) Subjects who have been judged as unsuitable for the study by the principal investigator 6) Subjects who regularly use medicines, foods for specified health uses, functional foods and / or supplements 7) Subjects who have a remarkable history of liver dysfunction, renal dysfunction, cardiovascular disease 8) Subjects who aged 60 and over and under 20 9) Subjects who have been treated for psychiatric disorders or sleep disorders so far, those who currently have symptoms to be treated 10) Subjects who are living irregularly 11) Subjects who are body types of lean type (BMI less than 18.5) or obese type (BMI 25 or more) 12) Subjects who engaged in night shift (after 22 o'clock) within the past 3 months 13) Subjects who has traveled to a country with a time difference of 3 hours or more within the past 3 months 14) Subjects who drinking alcohol daily 15) Subjects with smoking habits 16) Subject who intake caffeine per serving is 300 mg or more a day. 17) Subjects with a score of 30 in the morning / night type questionnaire (obvious night type) or 70 points (clear morning) 18) Subjects with an Epworth Sleepiness Scale score of 11 or higher 19) Sleep studies in Pittsburgh Subjects with a score of 5.5 or higher 20) Subjects weighing 36.3 kg or less 21) Subjects who have vomiting reflex abnormalities 22) Subjects transplanting electronic devices such as pacemakers
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of each sleep stage by PSG Energy metabolism indicator
- Secondary Outcome Measures
Name Time Method Sleep arousal evaluation by sleep diary Sleep arousal evaluation by activity meter Power value by frequency analysis of sleep brain waves Sleep evaluation at waking time Heart rate and heart rate variability measurement Measurement of body composition Urinary nitrogen emissions Incidence of side effects Incidence of adverse events