Healthy adult
Conditions
Interventions
Intake of test food for 8 consecutive weeks
Intake of control food for 8 consecutive weeks
Sponsors
EP Mediate Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Subjects who obtained the consent about participation in the study (2)males and females from 20 to under 65 years of age at the time obtaining consent (3)Subjects who complained of eye and nasal discomfort at Japanese cedar pollen season for the last 2 years (4)Subjects with CAP-RAST against JCP >= class 2
Exclusion criteria
Exclusion criteria: (1)Subjects having a disease requiring treatment or a history of serious diseases for which medication was required (2)Subjects who get the vaccine last week before the Japanese cedar exposure and 4 days after the exposure (3)Subjects who are treated with allergen immunotherapy (e.g. SLIT, SCIT etc.) and nonspecific desensitization therapy or surgery for allergic rhinitis (e.g. laser surgery etc.) within the 3 year prior to the time of obtaining consent about participation in the study or plan them during the study (4)Subjects who have acute rhinitis, nasal sinuses, hypertrophic rhinitis, or perennial allergy (5)Subjects who are taking antiallergic drug (except from ointment) (6)Subjects who received steroid medication (e.g. Kenacort-A) within the 6 months prior to the time of obtaining consent (7)Subjects who having a habit of drinking coffee, Pu-erh tea or Awa bancha tea more than 5 days a week (more than 100mL a day) (8)Subjects who are judged to be unsuitable based on the results of clinical examinations (9)Subjects who having food allergy (10)Subjects who are pregnant, and subjects who plan, may or wish to become pregnant during the study period (11)Subjects who were breastfeeding (12)Subjects who smoke excessively (more than 21 cigarettes a day) (13)Subjects who regularly consume large amount of alcohol (having >= 60g/day of alcohol more than 5 days a week ) (14)Subjects who have participated in other clinical study within the last three months at the time of obtaining consent (15)Subjects judged as unsuitable for the study by the investigator for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Record during pollen exposure (before entering ~ leaving exposure room) Subjective ocular and nasal discomfortable and disruption of daily routines (the number of sneezes , nose blowing, and Visual analogue scale(nasal blockage, nasal itching, disturbance of daily living [Overall behavior in the room and when using a smartphone/tablet], eye itching, watery eyes, throat symptoms, and sleepiness) | — |
Secondary
| Measure | Time frame |
|---|---|
| Record after pollen exposure (the first day of exposure and continuing for 5 successive days after exposure) Subjective ocular and nasal discomfortable and disruption of daily routines (the number of sneezes, nose blowing, and Visual analogue scale(nasal blockage, nasal itching, disturbance of daily living [Overall behavior in the room and when using a smartphone/tablet], eye itching, watery eyes, throat symptoms, and sleepiness) | — |
Countries
Japan
Contacts
Public ContactShinsuke Tsuji
EP Mediate Co., Ltd. R&D Support Center, Foods Department
Outcome results
None listed