Healthy adults
Conditions
Interventions
Daily intake of 2 packets of the test food for 12 weeks.
Daily intake of 2 packets of the placebo food for 12 weeks.
Sponsors
IMEQRD Co. Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age: 20 to 65 years. 2. Gender: Japanese men and women. 3. Individuals experiencing eye or nasal discomfort due to pollen, dust, house dust for the past two years. 4. Positive for specific IgE (Cedar, Hinoki, House dust 1, D. farinae). 5. Not taking allergy medications at the time of consent. Select more than half of the subjects from the healthy group among healthy and mildly affected individuals. a) Healthy group: Individuals experiencing eye or nasal allergic reactions due to pollen, dust, house dust for the past two years and not taking allergy medications b) Mildly affected group: Individuals experiencing eye or nasal allergic reactions due to pollen, dust, house dust for the past two years and occasionally* using (not regularly** taking) allergy medications. * "Occasionally" refers to use as needed. ** "Regularly" refers to taking medications consistently even when symptoms are absent. 6. Can input electronic diaries via smartphone or PC. 7. Provided written consent after receiving sufficient explanation and fully understanding the study objectives and content.
Exclusion criteria
Exclusion criteria: 1. Individuals with serious cardiovascular diseases (heart failure, myocardial infarction, myocarditis), liver diseases (liver failure symptoms (fulminant hepatitis), liver cirrhosis, liver tumors), kidney diseases (nephrotic syndrome, renal failure (acute and chronic), uremia, hydronephrosis) or any such systemic condition. 2. Individuals with allergies (medications and test food-related foods), especially those allergic totest food. 3. Individuals currently or planning to undergo exercise or dietary therapy under medical supervision. 4. Individuals needing to continue medications that might affect eye and nasal allergy symptoms (anti-allergy drugs, antihistamines, steroids, vasoconstrictors, hypotensives) during the study period. 5. Individuals regularly taking pharmaceutical, specific health foods, or health supplements (e.g., vitamins, lactic acid beverages/supplements aimed at alleviating eye and nasal discomfort). 6. Individuals habitually practicing nasal irrigation. 7. Individuals who do not go out at least once a week. 8. Individuals with extremely irregular eating habits. 9. Individuals who habitually consume excessive alcohol (pure alcohol intake: 40g or more/day). 10. Individuals with irregular lifestyles such as shift work or night work. 11. Individuals planning major changes in lifestyle (diet, sleep, exercise, etc.) during the study period. 12. Individuals planning overseas travel during the study period. 13. Pregnant, lactating women, or those intending to become pregnant during the study period. 14. Individuals who participated in another clinical study within one month before consent, currently participating, or planning to participate during the study period. 15. Any other individuals judged inappropriate for participation by the principal investigator or sub-investigators (e.g., increased risk to the subject due to participation, or potential difficulty in obtaining sufficient data).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Japanese Allergic Rhinitis QOL Standard Questionnaire (JRQLQ) | — |
Secondary
| Measure | Time frame |
|---|---|
| -Severity classification of allergic rhinitis symptoms -Examining eye and nasal symptoms -Blood test parameters (hematology, blood biochemistry) -Urinalysis -Physical examination (weight, BMI, blood pressure, pulse rate) | — |
Countries
Japan
Contacts
Public ContactYoshitada Hira
IMEQRD Co., Ltd Planning and Sales Department
Outcome results
None listed