Healthy Japanese
Conditions
Interventions
Test food: fatty acid oil Duration: 15 weeks
Test food: placebo fatty acid oil Duration: 15 weeks
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 have discomfort in the nose and eyes by pollen for the past two years 6. Individuals who do not use antiallergic drugs (except for who sometimes use them for discomfort in the nose and eyes by pollen)
Exclusion criteria
Exclusion criteria: Individuals who 1. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. are currently undergoing treatment for cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage at least four times a week 5. take functional food/beverage which may affect allergic reactions, such as beta-carotene, methylated catechins, lactic acid bacteria, bifidobacteria, rosmarinic acid, acetic acid bacteria, soy fermented polysaccharides, caffeic acid, luteolin, quercetin, hesperidin, or nobiletin at least four times a week 6. usually drink to excess (average of more than about 20 g/day as pure 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)} 7. are taking medications (including herbal medicines) and supplements 8. require to consecutively use medications which may affect nasal and eye allergic symptoms (antiallergic drugs, antihistamines, steroids, vasoconstrictors, antihypertensives, etc.) during this study 9. are allergic to medications and/or the test-food-related products (particularly gelatin) 10. have a nasal irrigation habit 11. do not go out more than once a week 12. cannot visit to the clinic at 12w and 15w 13. are pregnant, lactating, or planning to become pregnant during this study 14. have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate another study during this study 15. are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of allergic reaction of eyes and nose | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed