Effects of consumption of the test food on allergic reaction of eyes and nose in healthy Japanese subjects
- Conditions
- Healthy Japanese subjects
- Registration Number
- JPRN-UMIN000045540
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 36
Not provided
Subjects (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. currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, 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 that may affect allergic reaction, 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. 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)} 7. currently taking medications (including herbal medicines) and supplements 8. receiving long-term drug treatment (antiallergic drugs, antihistamines, steroids, vasoconstrictors, antihypertensives, etc.) that may affect allergic symptoms of the nose and eyes during the trial 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. are pregnant, lactation, or planning to become pregnant 13. 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 14. are judged as ineligible to participate in the study by the physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of allergic reaction of eyes and nose
- Secondary Outcome Measures
Name Time Method