Healthy adults
Conditions
Interventions
Consumption of the test food (1 pack a day, 8 weeks)
Consumption of the placebo food (1 pack a day, 8 weeks)
Sponsors
IMEQRD Co. Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participants aged 20 to 64 years 2. Japanese men and women 3. BMI over 18.5 and less than 30.0 kg/m^2 4. History of upper respiratory tract infection at least once per year 5. Able to enter electronic diaries via smartphone or PC 6. Sufficiently informed about the study and voluntarily consented in writing
Exclusion criteria
Exclusion criteria: 1. Currently receiving treatment for any disease with medication or Kampo (as-needed use allowed) 2. Under physician-supervised dietary or exercise therapy 3. History or presence of serious illness 4. History of gastrointestinal surgery (except appendicitis) 5. Atopic dermatitis, allergic rhinitis (seasonal/perennial), bronchial asthma, chronic bronchitis, or other immune-related diseases (e.g., autoimmune diseases) 6. Current or past treatment for dry mouth or Sjogren's syndrome 7. Consumes yogurt, lactic acid bacteria, or bifidobacteria foods at least 3 times per week, or unwilling to refrain during the study 8. Currently taking quasi-drugs, FOSHU, FFC, supplements, or health foods (allowed if discontinued after consent) 9. Plans to use drugs affecting immune function or gut flora (e.g., antiallergics, antibiotics) during the study 10. Vaccinated against influenza, COVID-19, etc., within 1 month before consent, or plans to be vaccinated during the study 11. Participants with current or past drug or food allergies 12. Irregular lifestyle due to night or shift work 13. Plans to significantly change lifestyle (diet, sleep, exercise) during the study 14. Heavy alcohol consumption (more than or equal to 40 g per day) 15. Excessive smoking (more than or equal to 21 cigarettes per day) 16. Plans for overseas travel during the study 17. Pregnant, breastfeeding, or planning pregnancy during the study 18. Currently using or planning to use oral contraceptives during the study 19. Donated more than 200 mL of blood within 1 month or more than 400 mL within 3 months before consent 20. Participated in other clinical studies within 1 month before consent, currently participating, or planning to participate during the study 21. Considered unsuitable for participation by the principal or sub-investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Salivary s-IgA concentration | — |
Secondary
| Measure | Time frame |
|---|---|
| - Questionnaire on cold-like symptoms - Fecal IgA concentration - IgA antibody titer (Influenza A) - Immune function assessment (T cell count, CD4 T cell count, CD8 T cell count, CD4/CD8 ratio, naive T cell count, memory T cell count, naive/memory ratio, CD8+CD28+ T cell count, B cell count, NK cell count, immune score, T lymphocyte age) - Salivary tests (cortisol, DHEA, oxytocin) - Blood tests (BAP, d-ROM) - Gut microbiota | — |
Countries
Japan
Contacts
Public ContactYoshitada Hira
IMEQRD Co., Ltd. Planning and Sales Department
Outcome results
None listed