Effects of consumption of the test food on the immunity in healthy Japanese subjects
- Conditions
- Healthy Japanese subjects
- Registration Number
- JPRN-UMIN000048865
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 64
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. The cumulative number of days with common cold symptoms during the intervention period per subject
- Secondary Outcome Measures
Name Time Method 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