Healthy male/female subjects
Conditions
Interventions
Ingestion of the test foods, five tablets a day.
Ingestion of the placebo foods, five tablets a day.
Sponsors
CPCC Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Male/female subjects ranging in age from 20 to 59 at informed consent. (2) Subjects with unsatisfactory sleep qualities (e.g., falling asleep, sleep, waking up). (3) Subjects working in the office continuously for five days a week. (4) 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 affecting foods (e.g., GABA), not less than once a week, (2) who will take medicines which might affect the test (e.g., sleep aid drug) during the test period, (3) who have been on antibiotics within the last 2 months before this study, (4) being under pharmacotherapy, diet remedy or ergotherapy, (5) with previous medical history of mental disorder, (6) with chronic fatigue syndrome, sleep disorder, sleep-apnea syndrome, prostate enlargement, overactive cystitis, (7) with night urinations, not less than twice a day, (8) engaging a physical labor, (9) with extremely irregular life rhythm, (10) with irregular bedtime and waking up, (11) having an irregular work, (12) with affecting rhinitis or pollinosis, (13) with over 30.0 kg/m2 of BMI, (14) with excessive alcohol intake, (15) having a habit of smoking, (16) with difficulty to stop drinking during the EEG measurement period or who are aware of stress caused by stop drinking, (17) planning to go on a business/long/event trip during the EEG measuring period, (18) who might be woken up by a roomer during sleep, (19) 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, (20) with pregnancy, possibly one, or lactating, (21) with medical history of serious diseases (e.g., cardiac), (22) who break out in a rash from putting electrodes on the head and neck, (23) with a pacemaker, (24) with drug/food allergy, (25) who donated their blood components or blood (0.2 L) within the last month, (26) who donated his blood (0.4 L) within the last 3 months, (27) who donated her blood (0.4 L) within the last 4 months, (28) being collected in total of his blood (1.2 L) within the last 12 months and in this study, (29) being collected in total of her blood (0.8 L) within the last 12 months and in this study, (30) being determined as ineligible for participation by the principal/sub investigator - - .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleep qualities (subjective sleep-assessment questionnaire, EEG measurement) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Visual Analogue Scale (fatigue feeling) 2. Visual Analogue Scale (stress) 3. Occupational stress questionnaire (abridged edition, 57 items, B-item only) | — |
Countries
Japan
Contacts
Public ContactMasanori Numa
CPCC Company Limited Clinical Planning Department
Outcome results
None listed