Healthy adults
Conditions
Interventions
After having breakfast or in the morning, take test food along with approximately 100cc water or lukewarm water every day for 8 weeks.
After having breakfast or in the morning, take placebo food alon
Sponsors
IMEQRD Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 20 to 64 years old (at the time of submission of an informed consent document). 2. Healthy Japanese males and females. 3. Those who have symptoms, such as sneezing, runny nose, congestion, and itchy eye, caused by pollen from sugi, etc. and who are allowed to participate in this study by the principal investigator. 4. BMI below 30 kg/m2 5. Those who can take test food for 8 weeks. 6. Smartphone or PC users (who can input their own data into the electronic diary). 7. Those who can receive sufficient explanation of the purpose and content of this study, who have ability to agree with the above explanation, who voluntarily participate in this study after coming to a better understanding, and who can give written informed consent. 8. Those who are regarded as not ill and allowed to participate in this study by the principal investigator or a sub-investigator.
Exclusion criteria
Exclusion criteria: 1. Those who are currently receiving some types of drug and Chinese medical treatments. 2. Those with acute rhinitis, sinusitis, nasal polyp, hypertrophic rhinitis, and deviated septum. 3. Those who had undergone intranasal surgery. 4. Those with coexisting bronchial asthma. 5. Those who have or had a severe disease of the liver, heart, kidneys, gastrointestinal tract, respiratory system, endocrine, and metabolism. 6. Those who are receiving specific hyposensitization therapy. 7. Those who take oral medication or nasal spray for antihistamines or anti-allergic drugs on a daily basis. 8. Those who take Lactobacillus preparation, supplements containing Lactobacillus, or yogurt on a daily basis. 9. Those who take food products with anti-allergic effects, such as "Tian Cha" derived from Chinese Blackberry leaves and "Memehana-cha" derived from 'Benifuki' cultivar, on a daily basis. 10. Those who may have allergic reactions to test food. 11. Those who are currently taking health food (such as supplements or food products to maintain or restore health), except for those who can temporarily stop taking the above health food at the time of submission of an informed consent document and remain the same until the end of this study. 12. Those who have a past and current medical history of drug or food allergy. 13. Those who are currently participating in another clinical trial or who had participated in another clinical trial conducted within a month prior to the submission of an informed consent document. 14. Those who are currently pregnant or breastfeeding and who want to become pregnant. 15. Heavy drinkers. 16. Smokers. 17. Those who experienced a feeling of being unwell or deterioration of health condition when they had blood drawn. 18. Those who may undergo lifestyle changes (such as a long trip) during the study period. 19. Those who were determined by the principal investigator to be unsuitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nasal examination in mucosa of the inferior turbinate (swelling and color), amount of mucus fluid, and characteristics of nasal discharge. Nasal and eye symptom survey. | — |
Secondary
| Measure | Time frame |
|---|---|
| Allergy tests for non-specific IgE in the blood, non-specific IgE (sugi or cypress), and eosinophil. The Japanese rhino-conjunctivitis quality of life questionnaire No 1 (JRQLQ No1) An antioxidant test to detect 8-hydroxy-2'- Deoxyguanosine (8-OHdG) in urine | — |
Countries
Japan
Contacts
Public ContactHirokuni Kayama
IMEQRD Co., Ltd. Planning and Sales Department
Outcome results
None listed