Healthy Japanese subjects
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. Men 3. Subjects aged 45 or more and less than 60 4. Healthy subjects 5. Subjects who work a five-day week 6. Subjects who meet the above inclusion criteria (1. to 5.) and meet the below criteria (a. or b.) (*A total of 160 subjects {80 subjects in each criterion (a. or b.)} will be selected) a. Subjects who are concerned about their sleep quality b. Subjects who are not concerned about their sleep quality 7. Subjects 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 observation period (*A total of 22 subjects {11 subjects in each criterion (c. or d.)} will be selected) c. Subjects whose score of PSQI is two or less d. Subjects whose score of PSQI is six or more
Exclusion criteria
Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily 5. Subjects who are currently taking medications (including herbal medicines) and supplements 6. Subjects who are allergic to medications 7. Subjects who are pregnant, lactating, or planning to become pregnant during this trial 8. Subjects who suffer from COVID-19 9. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 10. Subjects who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Metabolome analysis and multiple testing corrections (q-value) | — |
Secondary
| Measure | Time frame |
|---|---|
| The Pittsburgh Sleep Quality Index (PSQI) Japanese version and the St. Mary's Hospital sleep questionnaire (SMH) | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed