Healthy Japanese subjects
Conditions
Interventions
Duration: Four weeks Test food: Food containing lactic acid bacteria Administration: Take one packet between meals once a day. *If you forget to take the test food, take it as soon as you remembe
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 subjects 5. Subjects who catch colds easily
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 currently undergoing treatment for any of the following chronic diseases: 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 have pollen allergies 6. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily 7. Subjects who are currently taking medications (including herbal medicines) and supplements 8. Subjects who use immunosuppressants such as steroid 9. Subjects who are allergic to medicines and/or the test food related products 10. Subjects who have dairy-related allergies 11. Subjects who are pregnant, lactating, or planning to become pregnant during this trial 12. Subjects who suffer from COVID-19 13. Subjects who notice chronic cold symptoms 14. 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 15. Subjects who are judged as ineligible to participate in this study by the physician 16. Subjects who have received vaccination for influenza infection within one year
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The cumulative number of days with common cold symptoms during the intervention period per subject | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The maximum duration of the days with common cold symptoms during the intervention period per subject 2. Interleukin-12 (IL-12), interferon-alfa (IFN-alfa), and tumor necrosis factor-alfa (TNF-alfa) at four weeks after consumption | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed