Healthy adults
Conditions
Interventions
Consume 12 capsules/day of the test food every day for 8 weeks, accompanied by about 100 mL of water or lukewarm water, after breakfast or in the morning.
Consume 12 capsules/day of the placebo food e
Sponsors
S&B FOODS INC.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age: 20 or above and under 65 (at the time of consent). 2. Gender: Japanese nationality males and females. 3. Those who have nasal symptoms such as sneezing, runny nose, and nasal congestion caused by cedar pollen, but are judged by the research physician to have no problem participating in this trial. 4. Those who do not "take" or "sometimes take but do not regularly take" allergy medications before and during the research: Those who sometimes take are to be less than half of all subjects. 5. Those with a BMI less than 30 kg/m^2. 6. Those who can cooperate in taking the research food for 8 weeks. 7. Those who can enter electronic diaries via smartphones or PCs. 8. Those who have received a sufficient explanation about the purpose and content of this trial, have the ability to consent, understand well, voluntarily wish to participate, and can consent in writing to participate in this research. 9. Those who are judged by the research physician to not be patients and are deemed suitable to participate in this trial.
Exclusion criteria
Exclusion criteria: 1. Those currently receiving medical treatment or treatment with medicines or Kampo for any disease (intermittent use is acceptable). 2. Those with acute rhinitis, sinusitis, nasal polyps, deviated nasal septum, etc.. 3. Those who have undergone nasal cavity surgery. 4. Those with bronchial asthma. 5. Those who have or had serious liver, kidney, heart, respiratory, endocrine, metabolic diseases, etc. (appendicitis is acceptable). 6. Those undergoing specific desensitization therapy. 7. Those who regularly consume lactic acid bacteria products, lactic acid bacteria supplements, and yogurt (3 or more times a week) (those who can suspend consumption during the study period are acceptable). 8. Those who regularly consume foods with anti-allergy effects such as sweet tea and benifuuki tea (3 or more times a week) (those who can suspend consumption during the study period are acceptable). 9. Those who may have allergic symptoms to the research food. 10. Those who consume healthy foods (foods or supplements aimed at maintaining or recovering health) (those who can suspend consumption during the study period are acceptable). 11. Those with a current or past history of drug allergy or food allergy. 12. Those who have participated in other clinical trials within one month before consent acquisition or are currently participating. 13. Those who are currently pregnant or breastfeeding, and those who wish to become pregnant. 14. Those with excessive drinking habits exceeding about 40 g of pure alcohol per day. 15. Those with smoking habits (less than one year after quitting). 16. Those with shift work including night shifts. 17. Those who have experienced discomfort or deterioration of physical condition due to blood collection in the past. 18. Those who may change their lifestyle during the study period, such as long-term travel. 19. Others whom the research physician judges to be inappropriate as subjects of this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| JRQLQ Nasal Symptom Score | — |
Secondary
| Measure | Time frame |
|---|---|
| - JRQLQ Eye Symptom Score and QOL (Quality of Life) Score - Nasal Cavity Evaluation (Expansion of inferior nasal concha mucosa, Color tone of inferior nasal concha mucosa, Watery secretion amount and nasal fluid properties) - Cedar-specific IgE, Non-specific IgE | — |
Countries
Japan
Contacts
Public ContactHirokuni Kayama
IMEQRD Co, Ltd. Planning and Sales Department
Outcome results
None listed