Healthy Japanese
Conditions
Interventions
None listed
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Male 3. Middle age (45 years or older and less than 60 years old) 4. Healthy individuals 5. Individuals who work continuously for five days in a complete two-day weekend system 6. Individuals who meet the above inclusion criteria (1. to 5.) and meet the below criteria (a. or b.) (*A total of 730 individuals {365 individuals in each criterion (a. or b.)} will be selected) a. Individuals who are concerned about their sleep quality b. Individuals who are not concerned about their sleep quality 7. Individuals who meet the above inclusion criteria (1. to 6.) and meet the below criteria (c. or d.) based on the results of PSQI in the screening period (*A total of 100 individuals {50 individuals in each criterion (c. or d.)} will be selected) c. Individuals whose score of PSQI (PSQIG) is two or less d. Individuals whose score of PSQI (PSQIG) is six or more
Exclusion criteria
Exclusion criteria: 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 5. Individuals who are taking medications (including herbal medicines) and supplements 6. Individuals who are allergic to medications 7. Individuals who are pregnant, lactating, or planning to become pregnant during this study 8. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate or plan to participate another study during this study 9. Individuals who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Metabolome analysis (omega Scan 100 samples, quantification of 353 substances) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Salivary protein 2. The value of the Pittsburgh Sleep Quality Index (PSQI) {PSQI global score (PSQIG), "Sleep quality", "Sleep latency", "Sleep duration", "Habitual sleep efficiency", "Sleep disturbance", "Use of sleeping medication", and "Daytime dysfunction"} 3. The value of the OSA sleep inventory MA version (OSA-MA) {"Sleepiness on rising", "Initiation and maintenance of sleep", "frequent dreaming", "refreshing", "sleep length", and each item in OSA-MA} 4. The value of the Profile of Mood States 2nd Edition (POMS2) Japanese version {Tension-Anxiety (TA), Depression-Dejection (DD), Anger-Hostility (AH), Vigor-Activity (VA), Fatigue-Inertia (FI), Confusion-Bewilderment (CB), Friendliness (F), Total Mood Disturbance (TMD), and each item in POMS2} | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed