Efficacy evaluation of a food ingredient to ocular and nasal symptoms of allergy in healthy adults -Randomized, double-blind, placebo-controlled, parallel-group study-

UMIN ID: UMIN000056574

Registered date:06/01/2025

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: None
• Date of first enrollment: 2025/01/07
• Target sample size: 130
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Intakes of test powder for 8 weeks
Intakes of placebo powder for 8 weeks

Outcome(s)

• Primary Outcome: The discomfort of eyes and nose in the daily life
• Secondary Outcome: Evaluation of allergic rhinitis Specific measurement of blood

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude criteria: Individuals 1.who have some diseases with drug therapy. 2.who use antiallergic drugs or will use during the test period. 3.with a history of treatments other than medication aimed at alleviating allergy symptoms (such as intranasal laser therapy, sublingual immunotherapy, etc.). 4.who are a patient of or have a history of asthma. 5.who are a patient of or have a history of atopic dermatitis or chronic urticaria. 6.who are a patient or have a history of mental disease, psychiatric disease, high blood pressure, diabetes, and hyperlipidemia. 7.who consecutively receive drugs for treatment of disease in the last 1 month. 8.who could have severe allergy to foods or drugs. 9.who have severe disease histories in liver, kidney, heart, lung, blood or the other tissues. 10.who are a patient or have a history of endocrine disease. 11.whose BMI is over 30 kg/m2 12.who have donated over 200 mL of blood in the last 1 month or 400 mL of blood in the last 3 months. 13.who cannot stop to ingest intestinal drugs or supplements during the test period. 14.who had a habit to ingest health-promoting foods, health foods, or supplements containing similar composition with a test food or will ingest those foods during the test period. 15.who generally intake alcohol drinks over 60g/day as the amount of pure alcohol. 16.who could change their location and their lifestyle during the study, e.g., business trip or traveling for a long time. 17.who are pregnant, breastfeeding, or planning to be pregnant. 18.who participated in other clinical trials in the last 3 months. 19.who and whose family work for a company manufacturing or selling healthy foods, functional foods. 20.who refuse to disclose their biological sex. 21.who are judged unsuitable for this study by the investigator for other reasons.

Related Information

• Primary Sponsor: TES Holdings Company, Limited
• Source(s) of Monetary Support: Kirin Holdings Company, Limited