Healthy Japanese subjects
Conditions
Interventions
The test food Duration: 12 weeks
The placebo food Duration: 12 weeks
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese adult subjects who age 45 or more 2. Subjects who are anxious about their sleep quality 3. Subjects who have been fully informed of the purpose and content of this trial, have the capacity to consent, understand it well, voluntarily participate in the study, and agree to participate in this trial
Exclusion criteria
Exclusion criteria: Subjects who 1. undergoing medical treatment or having a medical history of malignant tumor, heart failure, or myocardial infarction, and have a pacemaker or an implantable cardioverter defibrillator 2. undergoing treatment for cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 3. use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage such as gamma-aminobutyric acid, crocetin, L-theanine, lactic acid bacteria that may affect sleep quality in daily 4. currently taking medicines (include herbal medicines) and supplements 5. allergic to medications and/or the test-food-related products. Particularly, gelatin or fish allergy 6. have factors that affect their sleep due to their home environment 7. Subjects who have irregular sleep habits due to irregular lifestyles (irregular meal timing, insufficient sleep, or night shifts, etc.) 8. have nocturia 3 times or more 9. 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)} 10. pregnant, breast-feeding, and planning to become pregnant 11. have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial 12. under treatment of sleeplessness or sleep disorder 13. judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of sleep quality by a sleep test | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed