Healthy Japanese subjects
Conditions
Interventions
Duration: 12 weeks Test food: Tablet containing garlic extract powder Administration: Take two tablets per day with water within 30 minutes after breakfast. *If you forget to take the test food,
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy subjects 5. Subjects who are judged as eligible to participate in the study by the physician according to the results of the Beck Depression Inventory (BDITM-II) at screening (before consumption)
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 are currently undergoing treatment of insomnia or sleep disorder 5. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily 6. Subjects who are currently taking medications (including herbal medicines) and supplements 7. Subjects who are allergic to medicines and/or the test food related products 8. Subjects who live with their infants less than one year old 9. Subjects who sleep with their children (one to six years old) 10. Subjects who live with requiring long-term care persons 11. Subjects who sleep with more than one person 12. Subjects whose sleeping time or habit is irregular due to work such as a late-night shift 13. Subjects whose dinner time is irregular 14. Subjects who are pregnant, lactating, or planning to become pregnant during this trial 15. 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 16. Subjects who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. "Initiation and maintenance of sleep" in the OSA sleep inventory MA version (OSA-MA) at 12 weeks after consumption (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. "Sleepiness on rising", "frequent dreaming", "refreshing", "sleep length", and each item in the OSA-MA at 12w 2. The total score, "Sleep quality"(C1), "Sleep latency"(C2), "Sleep duration"(C3), "Habitual sleep efficiency"(C4), "Sleep disturbance"(C5), "Use of sleeping medication"(C6), "Daytime dysfunction"(C7), and each item in the Japanese version of the Pittsburgh Sleep Quality Index at 12w 3. Each item in the St. Mary's Hospital sleep questionnaire at 12w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed