Healthy Japanese
Conditions
Interventions
<
Duration>
Two weeks <
Test 1: ETAS50 capsule Test 2: Placebo capsule <
Take three capsules daily, one capsule after each meal with water. *If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried o
Test 1: Placebo capsule Test 2: ETAS50 capsule <
Administration: Take three capsules daily, one capsule after each meal with water. *If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day a
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 individuals 5. Individuals who are dissatisfied with their sleep 6. Individuals whose BMI are 18.5 kg/m2 or more and 25 kg/m2 or less 7. The percentage of N3 measured using InSomnograf
Exclusion criteria
Exclusion criteria: 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or 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 undergoing treatment for sleep disorder 5. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 6. Individuals who are taking or using medications (including herbal medicines) and supplements 7. Individuals who are allergic to medicines and foods related to the test product, particularly who show allergic reactions to asparagus 8. Individuals whose sleeping habits are irregular due to night shifts and other lifestyle reasons 9. Individuals who sleep with more than one person 10. Individuals who live with requiring long-term care persons or their infants 11. Individuals who usually drink to excess (average of more than about 20 g/day as absolute alcohol intake) {500 mL: a medium bottle of beer or about 1.5 cans of canned chu-hi, 180 mL: 1 go of sake or about 1.5 glasses of wine, 90 mL: half-go with shochu, 60 mL: a glass of whiskey brandy (double)} 12. Individuals who consume at least 3 mugs (about 230 mL/mugs) of coffee per day 13. Individuals who are pregnant, lactating, or planning to become pregnant during this study 14. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study 15. Individuals who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Brain wave score during sleep with InSomnograf | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. OSA sleep inventory MA version (OSA-MA) 2. Athens Insomnia Scale (AIS) | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed