Healthy Japanese subjects
Conditions
Interventions
Duration: 12 weeks Test food: Plant A oil Administration: Take two packets (4.4 g/packet x two packets, in total 8.8 g) at any time during the day
Duration: 12 weeks Test food: Plant B oil Adm
Sponsors
Synapse planning Co.,Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Healthy adult males and females from 20 to 65 years of age 3. Subjects who have eyes and nose discomfort by pollen at last two years 4. Subjects who have positive for specific IgE against cedar or cypress or house dust or mites. 5. Subjects who do not use antiallergic drugs at the agreement to participate in this trial 6. Subjects whose total score of JRQLQ is bad at screening 7. Subjects who receive a comprehensive explanation of this study, can understand it, and provide a written informed consent
Exclusion criteria
Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who are allergic to medicines and/or the test food related products (particularly, plant A, plant A oil, plant B, or plant B oil) 3. Subjects who are currently, exercise therapy and diet therapy are performed/ planning to under the supervision of a physician 4. Subjects who are pregnant, lactating, or planning to become pregnant during this trial 5. Subjects who are 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 6. Subjects who are currently taking medicines, foods for specified health uses, health foods, etc. (e.g. vitamins, lactic acid drinks/supplements for the purpose of alleviating discomfort in the eyes and/or nose.) 7. Subjects who have a nasal irrigation habit 8. Subjects who do not go out more than once a week 9. Subjects whose eating habit is extremely irregular 10. Subjects who are routinely drinking a large amount of alcohol. 11. Subjects whose life rhythms are irregular due to shift work, night work, or others 12. Subjects who have been enrolled in other clinical trials within one month before the agreement to participate in this trial or plan to participate another trial during this trial 13. Subjects who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Japanese rhino-conjunctivitis quality of life questionnaire (JRQLQ) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Grading the severity of allergic rhinitis 2. Medical examination for check subjects nasal and eye symptom survey and nasal condition 3. The number of eosinophils in nasal discharge and specific IgE (Four types: Japanese red-cedar, cypress, Dermatophagoides pteronyssinus, and house dust) | — |
Countries
Japan
Contacts
Public ContactMasakazu Tomaru
Synapse planning Co.,Ltd. Representative of Director
Outcome results
None listed