Healthy Japanese subjects
Conditions
Interventions
Duration: 12 weeks Test food: A Administration: Take two capsules of the test food with water before 10 to 15 minutes in breakfast and dinner *If you forget to take the test food, take it as soon
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. Male or female 3. Subjects aged 20 or more 4. Healthy subjects 5. Subjects who are judged as eligible to participate in the study by the physician 6. Subjects whose scoring of immunological vigor is 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 1. The maximum duration of the days with common cold symptoms (*) during the intervention period per subject 2. The measured values and amount of change from before consumption (Scr) in each of the following items at eight weeks after consumption (8w): immunity test {scoring of immunological vigor, immunological grade, T lymphocyte age (upper limit), the score of T cells, the score of CD8+CD28+T cells, the score of ratio of CD4+T cells to CD8+T cells, the score of naive T cells, the score of ratio of naive T cells to memory T cells, the score of B cells, the score of NK cells, the number of T cells, the ratio of CD4+T cells to CD8+T cells, the number of naive T cells, the ratio of naive T cells to memory T cells, the number of B cells, the number of NK cells, the number of CD8+CD28+T cells}, the amount of change of inflammatory markers {interleukin (IL)-6, IL-1 beta, tumor necrosis factor-alfa, high sensitivity C-reactive protein, the number of leukocyte, leukocyte image (the ratio and number of neutrophil, lymphocyte, monocyte, eosinophil, and basophil)} and neutrophil/lymphocyte ratio 3. The measured values and amount of change from Scr in each of the following items at 8w and 12 weeks after consumption (12w): Circulating markers of liver function {asparate aminotransferase (AST), alanine aminotransferase (ALT), and gamma-glutamyltranspeptidase (gamma-GT)}, body weight, body mass index, body fat percentage, and muscle mass * 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 | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed