Healthy adults
Conditions
Sponsors
KSO Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Healthy Japanese males and females from 20 to 65 years old. 2) Subjects who have received sufficient explanation of the purpose and content of the study, have the capacity to consent, have voluntarily volunteered to participate based on a good understanding of the study, and have agreed to participate in the study in writing.
Exclusion criteria
Exclusion criteria: Subjects-- 1) suffering from, undergoing treatment, or with a history of diabetes, renal or hepatic disease, or other serious illness, thyroid disease, adrenal gland disease, psychiatric disease, autoimmune disease, or other metabolic disease. 2) who cannot stop taking foods containing lactic acid bacteria, bifidobacteria, oligosaccharides, or other viable bacteria during the study period. 3) who regularly use foods that may affect immunity. 4) who constantly consumes more than the appropriate amount of alcohol. 5) who are unable to abstain from alcohol for 2 days prior to each test. 6) who have declared having food allergies. 7) with a history of gastrointestinal diseases or gastrointestinal surgery (except appendicitis). 8) who are pregnant, breast feeding, or planning to be pregnant during the study period. 9) with a history or current history of drug or alcohol dependence. 10) who are participating or intend to participate in other studies involving the use of other foods, drugs or cosmetics. 11) who regularly use medicines that may affect immunity, or who are unable to stop taking them during the study period. 12) with hay fever, atopic dermatitis, allergic rhinitis, bronchial asthma, or chronic bronchitis. 13) who plan to visit the hospital or take/use prescription medication annually due to hay fever or allergic rhinitis. 14) who have oral problems that involve bleeding, or plan to undergo dental or oral treatment. 15) who engage in strenuous exercise. 16) who plan to travel abroad during the study period. 17) who have taken antibiotics within 1 month of the screening test. 18) who smoke. 19) who are diagnosed as anemic by screening tests and are not suitable for blood sampling. 20) who have donated blood drawn or component blood more than 200 mL within 1 month or 400 mL within 3 months prior to the date of obtaining consent. 21) who work in day and night shifts, late at night, or who are full telecommuters or blue-collar workers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| cold-like symptoms questionnaire | — |
Secondary
| Measure | Time frame |
|---|---|
| mDC activity, salivary sIgA, NK cell activity, CD8+T cell activity, CD4+T cell activity, B cell activity intestinal condition questionnaire, SF-36, stress and other things measured by visual analog scale (VAS), OSA sleep inventory MA version (OSA-MA) | — |
Countries
Japan
Contacts
Public ContactEiji Yoshikawa
KSO Corporation Clinical Trial Management department
Outcome results
None listed