Healthy Japanese subjects
Conditions
Interventions
Duration: Four weeks Test food: Tablets containing Corchorus olitorius L. Administration: Take a total of 30 tablets per day between meals with water and no chewing * If you forget to take the t
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese adult subjects 2. Subjects who are experiencing daily fatigue 3. Subjects who are judged as eligible to participate in the study by the physician 4. Subjects who have relatively low scoring of immunological vigor at screening (before consumption)
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. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Function Claims", or other functional food/beverage in daily 5. Subjects who are currently taking medications (including herbal medicines) and supplements 6. Subjects who regularly use anticoagulants, such as warfarin 7. Subjects who are smokers 8. Subjects who are diagnosed with pollen allergy 9. Subjects who are allergic to medicines and/or the test food related products 10. Subjects who are pregnant, lactation, or planning to become pregnant 11. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to enroll in anther clinical trial during trial period 12. Subjects who are ineligibility to participate in the study based on the evaluation of the principal physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Scoring of immunological vigor * Assess the measured value at screening (before consumption) and at four weeks after consumption. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Immunological age 2. T lymphocyte age 3. CD3+T cell ratio 4. CD4+T cell ratio 5. CD8+T cell ratio 6. Naive T cell ratio (CD4+) 7. Memory T cell ratio (CD4+) 8. CD8+CD28+T cell ratio 9. B cell ratio (CD20+) 10. NK cell ratio (CD56+16-) 11. NK cell ratio (CD56+16+) 12. NK cell ratio (CD56-16+) 13. Number of CD3+T cells 14. Number of CD4+T cells 15. Number of CD8+T cells 16. CD4+T cell/CD8+ T cell ratio 17. Number of naive T cells 18. Number of memory T cells 19. Naive T cell/memory T cell ratio 20. Number of B cells 21. Number of NK cells 22. T-cell proliferation index 23. T cell proliferative capacity 24. Immunological grade 25. Scoring of T cells 26. Scoring of T-cell proliferation index 27. Scoring of CD4 T cell/CD8 T cell ratios 28. Scoring of naive T cells 29. Scoring of naive T cell/memory T cell ratios 30. Scoring of B cells 31. Scoring of NK cells 32. Scoring of CD8+CD28+T cell ratios 33. Subjective symptoms (The Likert scale method) *1-33 Assess the measured value at screening (before consumption) and at four weeks after consumption. | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed