Healthy subject
Conditions
Interventions
Trial supplement (4 days) - washout period - placebo (4 days)
Placebo (4 days) - washout period - trial supplement (4 days)
Sponsors
KSO Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Japanese males and females aged from 20 to less than 65 years old. 2) Subjects who are weekday workers 3) Global score of Pittsburgh Sleep Quality Index-Japanese version is more than 6. 4)Subjects who can understand the detail of this study and decide to attend the study.
Exclusion criteria
Exclusion criteria: 1) Subjects who are routinely use the health food, dietary supplement, and medicine including over-the-counter drug for improving of sleep or fatigue. 2) Subjects with excessive alcohol-drinking behaviors. 3) Subjects who cannot stop drinking alcohol during study period I and II 4) Subjects who are under the medication, counseling, or exercise therapy. 5) Subjects who have under treatment or history of disease such as diabetes, liver disease, kidney disease, heart disease, adrenal cortex disease. 6) Subjects who have under treatment or a history of sleep apnea syndrome or is suspected of sleep apnea syndrome. 7) Night and day shift worker or manual laborer 8) Working days and holidays are irregular 9) Subjects who have mental illness or insomnia. 10) Subjects who will use medicine for Perennial allergic rhinitis in study period. 11) Heavy smoker 12) Subjects having possibilities for emerging allergy related to the study foods. 13) Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating. 14) Subjects who have heavy menstrual cramps and premenstrual syndrome. 15) Subjects who are planned to participate in other clinical study 16) Subjects who are judged as unsuitable for the study by the investigator for other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OSA sleep inventory MA version | — |
Secondary
| Measure | Time frame |
|---|---|
| Sleep electroencephalogram, POMS 2 brief form, visual analogue scale (VAS) for fatigue, VAS for daytime sleepiness | — |
Countries
Japan
Contacts
Public ContactEiji Yoshikawa
KSO Corporation Sales department
Outcome results
None listed