Effects of consumption of test food consumption on immune function in healthy Japanese subjects
- Conditions
- Healthy Japanese subjects
- Registration Number
- JPRN-UMIN000046160
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 99
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 disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, gastroesophageal reflux disease, hormone sensitive diseases, iron deficiency, or any other chronic diseases 4. Subjects who take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily use 5. Subjects currently taking medicines (include herbal medicines) and supplements 6. Subjects who are allergic to medications and/or the test-food-related products 7. Subjects who suffer from COVID-19 8. Subjects who are pregnant, breast-feeding, and planning to become pregnant 9 .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 10. Subjects who are smokers 11. Subjects who have autoimmune disease 12. Subjects who are taking immunosuppressants such as steroids 13. Subjects who have received vaccination for influenza within the last three months 14. Subjects who have surgery within the last two weeks 15. Subjects who are judged as ineligible to participate in the study by the physician
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 * The common cold symptom is defined as the onset of more than one of the following symptoms: whole body malaise, chilliness, feverishness, fatigue, sneezing, nasal discharge, blocked nose, throat pain, cough, joint pain, and muscle pain
- Secondary Outcome Measures
Name Time Method