Validation study on sleep-improvement effects by test-food intakes
- Conditions
- Healthy male/female subjects
- Registration Number
- JPRN-UMIN000050446
- Lead Sponsor
- CPCC Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 140
Not provided
Subjects - - (1) taking in sleep-affecting foods (e.g., GABA), not less than three times a week, (2) who will take medicines which might affect the test (e.g., sleeping pill) during the test period, (3) with insomnia, sleep-apnea syndrome, restless legs one, overactive cystitis, reflux esophagitis, (4) with affecting rhinitis or pollinosis, (5) with a pacemaker, (6) with an alcohol intake during the test period, (7) having a habit of smoking, (8) with previous medical history of mental disorder, (9) with abnormal carbohydrate metabolism at pre-test 1, (10) with medical history of serious diseases (e.g., cardiac), (11) with extremely irregular life rhythm, (12) planning affecting life-events during the test period, (13) planning to go on a business/long/event trip during the brain-wave measuring period, (14) with night urinations, not less than twice a day, (15) cannot use a bedding by themselves, (16) who might be woken up by a roomer during sleep, (17) who have been diagnosed as dry mouth, (18) with intraoral bleeding tendency, (19) with pregnancy, possibly one, or lactating, (20) with drug/food allergy, (21) being under another clinical test (medicine or health food), or participated in that within the last 4 weeks, or will join that after the consent, (22) who donated their blood components or blood (0.2 L) within the last month, (23) who donated his blood (0.4 L) within the last 3 months, (24) who donated her blood (0.4 L) within the last 4 months, (25) being collected in total of his blood (1.2 L) within the last 12 months and in this study, (26) being collected in total of her blood (0.8 L) within the last 12 months and in this study, (27) who break out in a rash from putting electrodes on the head and neck, (28) being determined as ineligible for participation by the principal/sub investigator - - .
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sleep qualities (brain-wave measurement, Oguri-Shirakawa-Azumi sleep inventory ver. MA)
- Secondary Outcome Measures
Name Time Method 1. Pittsburgh sleep quality index 2. Epworth sleepiness scale 3. Visual Analogue Scale (fatigue feeling) 4. Visual Analogue Scale (sleep) 5. Amylase in saliva 6. Growth hormone in blood 7. Insulin-like Growth Factor-1 in blood 8. The Profile of Mood States second edition (short ver.)