None listed
Conditions
Interventions
Intake test food for two weeks. Rest for two weeks. Intake control food for two weeks.
Intake control food for two weeks. Rest for two weeks. Intake test food for two weeks.
Sponsors
CPCC Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese males and females aged 20 to 64 years old and who are dissatisfied their sleep. 2. Subjects who have a custom of going bed before 24 o'clock 3. Subjects their score of Athens Insomnia Scale are between 6 and 9. 4. Subjects who receive enough explain of the test, who deeply understanding of the test, and who obtain own consent to participate the test.
Exclusion criteria
Exclusion criteria: Subjects who 1.are given continuous treatment by taking medicines. 2.constantly use oral medicines having a possibility of affecting test results. 3.constantly use food having a possibility of affecting test results, such as food for specific health use. 4.have current and/or previous medical history of serious disease. 5.have current and/or previous medical history of sleep disorder. 6.self-aware about their sleep apnea. 7.awake during sleep more than two times a week due to night urination. 8.have allergic rhinitis. 9.use pacemaker. 10.have previous medical history of allergy for medicine and/or food. 11.those BMI are over 30 kg/m2. 12.tend to have skin rash with adhesive tape due to skin hypersensitivity. 13.are pregnant or lactating. 14.have extremely irregular dining and life habits. 15.excessive alcohol intake. 16.are not be able to avoid alcohol intake during test period. 17.are not be able to use electroencephalograph during test period. 18.have plan lodging by travel and/or business trip. 19.are participating the other clinical tests, participated within 4-weeks prior to the current study and/or plan to participate the other clinical tests. 20.donated over 200mL blood and/or blood components within the last one month. And 21.Males who donated over 400mL blood and/or blood components within the last three month. 22.Females who donated over 400mL blood and/or blood components within the last four month. 23.Males who will be collected over 1200mL blood and/or blood components, when the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study. 24.Females who will be collected over 800mL blood and/or blood components when, the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study. 25.Others who have been determined ineligible by principal investigator or sub-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Condition of sleep, stress and fatigue, assessed by electroencephalography, OSA sleep inventory, VAS questionnaire for feeling of fatigue, POMS2 short version or St. Mary's hospital sleep questionnaire | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence rate of adverse events and side effects | — |
Countries
Japan
Contacts
Public ContactMakoto Ichinohe
CPCC Company Limited Planning & Sales Department
Outcome results
None listed