Verification test on biological reactions during artificial exposure to pollen from ingestion of research target food

UMIN ID: UMIN000051546

Registered date:26/12/2024

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Healthy adult
• Date of first enrollment: 2023/07/08
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Intake of test food for 8 consecutive weeks
Intake of control food for 8 consecutive weeks

Outcome(s)

• Primary Outcome: 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 Outcome: 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)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: EP Mediate Co., Ltd.
• Source(s) of Monetary Support: Meiji Co., Ltd.