Healthy Japanese
Conditions
Interventions
Duration: 12 weeks Test food: Tablet containing Tetragenococcus halophilus No.1 Administration: Take one tablet with water at the breakfast once a day *If you forget to take the test food, take i
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy individuals 5. Individuals who are aware that they get sick easily or catch a cold easily 6. Individuals whose MFI of pDC is relatively low at screening (before consumption) among those who meet inclusion criteria No. 1~5 without meeting any of exclusion criteria
Exclusion criteria
Exclusion criteria: 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Individuals who have autoimmune disease 5. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 6. Individuals who are taking medications (including herbal medicines) and supplements 7. Individuals who use immunosuppressants such as steroid 8. Individuals who are allergic to medicines and/or the test food related products 9. Individuals who have pollen allergies 10. Individuals who are pregnant, lactating, or planning to become pregnant during this study 11. Individuals who suffer from COVID-19 12. Individuals whose working hours are irregular 13. Individuals who have irregular lifestyles (such as diet, exercise, and sleep) 14. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate another study during this study 15. Individuals who are judged as ineligible to participate in this study by the physician 16. Individuals who have received vaccination for influenza virus within the last three months before the agreement to participate in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured values of median fluorescence intensity (MFI) for CD40, CD80, CD86, and human leukocyte antigen-DR (HLA-DR) in plasmacytoid dendritic cells (pDC) at 12 weeks after consumption (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured values of positive cell percentages for CD40, CD80, CD86, and HLA-DR in pDC at 12w 2. The measured values of interferon-alpha 2a (IFN-alpha 2a), natural killer (NK) cell activity, salivary secretory immunoglobulin A (sIgA) at 12w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed