Healthy male/female subjects
Conditions
Interventions
Consumption of the test food (once a day, 4 capsules each).
Consumption of the placebo food (once a day, 4 capsules each).
Sponsors
CPCC Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Male/female subjects ranging in age from 30 to 59 at informed consent. (2) Subjects with less than 30.0 kg/m2 of BMI. (3) Subjects who work as usual, except every weekend. (4) Subjects having the habit of going to bed by 24 o'clock. (5) Subjects with unsatisfactory sleep. (6) Subjects who can give informed consent to partake in this study, after being provided with an explanation of the protocol detail.
Exclusion criteria
Exclusion criteria: 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 - - .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleep qualities (brain-wave measurement, Oguri-Shirakawa-Azumi sleep inventory ver. MA) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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.) | — |
Countries
Japan
Contacts
Public ContactMasanori Numa
CPCC Company Limited Clinical Planning Department
Outcome results
None listed