Healthy adults
Conditions
Interventions
4-week intake of research food (high dose)
4-week intake of research food (low dose)
4-week intake of control food
Sponsors
KSO Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females from 20 to 65 years old at the time of the informed. 2. Subjects who often suffer from fever or illness. 3. Subjects who have been fully informed of the purpose and content of the research, have the capacity to consent, and have voluntarily volunteered to participate based on a good understanding of the purpose and content of the research, and have agreed to participate in the research in writing.
Exclusion criteria
Exclusion criteria: Subjects - - 1. scheduled to be vaccinated for 3 weeks prior to each examination. 2. suffering from diabetes, renal or hepatic disease or other serious diseases, or metabolic diseases, autoimmune diseases, undergoing treatment, or with a history of such diseases. 3. with chronic illnesses who take pharmaceuticals on a daily basis. 4. who regularly use medicines that may affect immunity, foods for specified health uses, etc, and who are unable to stop taking them during the study period. 5. who are unable to stop taking Lactobacillus and Bifidobacteria-rich foods during the study period. 6. who have taken antibiotics for 1 month prior to the screening test. 7. who constantly consumes alcohol in excess of the appropriate amount. 8. who are unable to abstain from alcohol for 2 days prior to each test. 9. with declared food allergies. 10. with a history or current history of hay fever. 11. with atopic dermatitis, allergic rhinitis, bronchial asthma, or chronic bronchitis. 12. who work day and night shifts. 13. who work full-time telecommuters. 14. who have dental or oral problems that involve bleeding, or plan to undergo dental or oral treatment. 15. who have a habit of jogging or other strenuous exercise. 16. who smoke. 17. with gastrointestinal diseases and absorption and a history of gastrointestinal surgery (except appendicitis). 18. who a pregnant, intending to become pregnant during the study period, or breastfeeding. 19. with a history or current history of drug or alcohol dependence. 20. who are currently participating in research involving the ingestion of other foods or the use of pharmaceuticals, or who intend to participate in such research. 21. who have donated more than 200 mL of blood or component blood within 1 month or 400 mL within 3 months prior to the date consent was obtained. 22. who deemed inappropriate as research subjects by the principal investigator--.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NK cell activity | — |
Secondary
| Measure | Time frame |
|---|---|
| pDC activity, salivary sIgA (concentration, rate of secretion, amount secreted), concentration of IFN-alfa in blood, cold-like symptoms questionnaire | — |
Countries
Japan
Contacts
Public ContactYoshikawa Eiji
KSO Corporation Clinical Trial Management department
Outcome results
None listed