Healthy adults
Conditions
Interventions
Participants take two capsules of the test food once daily with water, for 4 weeks.
Participants take two capsules of placebo food once daily with water, for 4 weeks.
Sponsors
IMEQRD Co. Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 20 to 65 years 2. Japanese men and women 3. BMI less than 30.0 kg/m^2 4. Experience hay fever symptoms every March-April and, at consent, meet one of the following: a. Healthy: Have had ocular/nasal allergic reactions to pollen, dust, or house dust for the past two years and have not used allergy medication b. Mild: Have had ocular/nasal allergic reactions to pollen, dust, or house dust for the past two years and occasionally* use allergy medication (not regularly*) *Occasionally: Used as needed, less than three times per week, only when symptoms are severe *Regularly: Taken routinely even when asymptomatic 5. Able to enter electronic diaries via smartphone or PC 6. Voluntarily consented in writing after receiving sufficient explanation and understanding the study
Exclusion criteria
Exclusion criteria: 1. Currently receiving medication for chronic disease 2. Currently under dietary or exercise therapy supervised by a physician 3. Current or past history of serious illness 4. Taking over-the-counter drugs, quasi-drugs, health foods, supplements, Foods for Specified Health Uses, or Foods with Functional Claims (participation allowed if discontinued after consent and during the study) 5. going outside for more than an hour at a time less than once per week 6. Current or past history of food or drug allergies 7. Habitual excessive alcohol intake (>=40g pure alcohol/day) 8. Habitual excessive smoking (>=21 cigarettes/day) 9. Irregular lifestyle, such as shift or night work 10. Plans to significantly change lifestyle (diet, sleep, exercise) during the study, e.g., long trips 11. Pregnant, breastfeeding, or planning pregnancy during the study 12. Participating in another clinical trial, within four weeks after another trial, or planning to join another trial after consenting to this study 13. Deemed unsuitable for participation by the principal or sub-investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| JRQLQ questionnaire, before and after intake of the test food capsules | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood tests (histamine levels, white blood cell count and differential), nasal eosinophil count, and allergy symptom questionnaires, before and after intake of the test food capsules | — |
Countries
Japan
Contacts
Public ContactYoshitada Hira
IMEQRD Co., Ltd. Planning and Sales Department
Outcome results
None listed