Healthy Japanese subjects
Conditions
Interventions
Duration: Four weeks Test food: Capsule containing lactic acid bacteria Administration: Take one capsule with water per day at any time during the day *Daily dose should be taken within the day.
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. Subjects aged 20 or more 4. Healthy subjects 5. Subjects who catch colds easily 6. Subjects who have received vaccination for SARS-Cov-2 at least two times 7. Subjects who are judged as eligible to participate in the study by the physician 8. Subjects who have low scoring of immunological vigor at Scr
Exclusion criteria
Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects who currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who have autoimmune disease 5. Subjects who use or take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage in daily 6. Subjects who cannot stop taking the food containing lactic acid bacteria (such as natto, yogurt, and fermented food) or lactic fermenting beverage during the test period 7. Subjects who currently taking medications (including herbal medicines) and supplements 8. Subjects who are taking immunosuppressants such as steroids 9. Subjects who are allergic to medicines and/or the test beverage related products 10. Subjects who have pollen allergy or perennial allergic rhinitis 11. Subjects who are pregnant, breast-feeding, and planning to become pregnant 12. Subjects who suffer from COVID-19 13. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 14. Subjects who are judged as ineligible to participate in the study by the physician 15. Subjects who have received vaccination for influenza within the last three months before the agreement to participate in this trial 16. Subjects who plan to receive vaccination for SARS-Cov-2 during the test period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The measured values and amount of change from screening (before consumption; Scr) in each of the following items at four weeks after consumption (4w): scoring of immunological vigor, T lymphocyte age, the number of T cells, the ratio of CD4+T cells to CD8+T cells, the number of naive T cells, the ratio of naive T cells to memory T cells, the score of B cells, the score of NK cells, and the number of CD8+CD28+T cells | — |
Secondary
| Measure | Time frame |
|---|---|
| The measured values and amount of change from Scr of interferon (IFN)-alfa, the activity of plasmacytoid dendritic cells (pDC), and immunoglobulin G of SARS-Cov-2, and the maximum duration of the days with common cold symptoms during the intervention period | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed