Healthy Japanese subjects
Conditions
Interventions
Duration: 12 weeks Test food: Tablet containing lactic acid bacteria Administration: Take one tablet with water at the breakfast once a day *If you forget to take the test food, take it as soon a
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 easily feel tired and catch colds 6. Subjects whose IgA are relatively low
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 use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily 6. Subjects who are currently taking medications (including herbal medicines) and supplements 7. Subjects who take immunosuppressants such as steroid 8. Subjects who are allergic to medicines and/or the test food related products 9. Subjects who have pollen allergies 10. Subjects who are pregnant, lactation, or planning to become pregnant during this trial 11. Subjects who suffer from COVID-19 12. Subjects whose working hours are irregular 13. Subjects who have irregular lifestyles (such as diet, exercise, and sleep) 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 within the last three months
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. Immunoglobulin A (IgA) and IgG at 12 weeks after consumption | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed