Saliva metabolome study in huma
- Conditions
- Healthy Japanese
- Registration Number
- JPRN-UMIN000053021
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- Male
- Target Recruitment
- 100
Not provided
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Metabolome analysis (omega Scan 100 samples, quantification of 353 substances)
- Secondary Outcome Measures
Name Time Method 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}