Verification for the effects of consumption of the test food on allergy-like symptoms
- Conditions
- Healthy Japanese subjects
- Registration Number
- JPRN-UMIN000042583
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 44
Not provided
Subjects who (are) 1.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 3.currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver, kidney, or cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4.currently being treated with any kind of drug or herbal medicine (except for single use) 5.have acute rhinitis, sinusitis, nasal polyp, hypertrophic rhinitis, or nasal septum deviation 6.have undergone nasal surgery (coagulation necrosis, excision, etc.) in the past 7.with concomitant bronchial asthma 8.have a symptom or a history of a serious liver, cardiac, renal, gastrointestinal, respiratory, endocrine, or metabolic disease (except for appendicitis) 9.undergoing specific hyposensitization 10.currently taking an oral or nasal antihistamine or antiallergic medication 11.take lactobacillus preparation and/or supplements or yogurt in daily use 12.take foods with antiallergic effects such as sweet tea, memehana tea etc. in daily use 13.take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage in daily use 14.currently taking medications (including herbal medicines) and supplements 15.have a past or current medical history of allergies to medicines and/or foods 16.have a risk of allergies to the test food 17.have been enrolled in other clinical trials within the last 3 months before the agreement to participate in this trial or plan to participate another trial during this trial 18.pregnant, breast-feeding, or planning to become pregnant 19.drink alcohol immoderately 20.smokers 21.have experienced sick or deteriorated health after blood sampling in the past 22.may change their lifestyles, such as long trips, during this trial 23.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 1. The measured value and change from screening of each score of the Japanese Rhino-conjunctivitis Quality of Life Questionnaire (JRQLQ) at four and eight weeks after consumption (4w and 8w) 2. The measured value of each question item of JRQLQ at 4w and 8w 3. The measured value of the questionnaire based on practical guideline for the management of allergic rhinitis in Japan at 4w and 8w
- Secondary Outcome Measures
Name Time Method 1. The measured values and changes from screening of serum specific IgE levels (Japanese red-cedar, cypress, house dust, and Dermatophagoides pteronyssinus), eosinophils count in nasal discharge, and serum basophils counts and eosinophil cationic protein (ECP) levels at 4w and 8w 2. The swelling of nasal mucosa at 4w and 8w