Healthy Japanese subjects
Conditions
Interventions
Take the test food for eight weeks
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 feel tired on a daily basis 6. Subjects whose salivary IgA is relatively low
Exclusion criteria
Exclusion criteria: Subjects 1. who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. 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. who usually take "Foods for Specified Health Uses," or "Foods with Functional Claims" / particularly who use dietary fiber ingredients (such as fructo oligosaccharide, indigestible dextrin, and polydextrose) or dietary supplements for the immunostimulation 5. who are currently taking medications (including herbal medicines or immunosuppressants such as steroid) and supplements 6. who are allergic to medicines and/or the test food related products or have seasonal allergic rhinitis (hay fever), perennial allergic rhinitis, asthma, atopic dermatitis, allergic conjunctivitis, food allergy, or metal allergy 7. who are pregnant, lactating, or planning to become pregnant during this trial 8. who have received preventive vaccination for influenza within the last three months 9. who have undergone or plan to undergo dental or oral treatment {treatment of dental decay, periodontal disease, or others, including periodic scaling (dental cleaning)} between one month prior to the agreement to participate and completion of this trial 10. who have bleeding tooth or oral problems such as stomatitis 11. who work in shifts or physical labor such as transportation of heavy objects 12. who suffer from COVID-19 13. 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 14. who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The plasmacytoid dendritic cell (pDC) activity at eight weeks after consumption (8w) 2. Interleukin-10 (IL-10), interferon-gamma (IFN-gamma), tumor necrosis factor-alfa (TNF-alfa), and natural killer (NK) cell activity at 8w 3. Immunoglobulin A (IgA), acetic acid, propionic acid, isobutyric acid, n-butyric acid, isovaleric acid, n-valeric acid, lactic acid, succinic acid, formic acid and water content in the stool at 8w 4. Secretary IgA (s-IgA) in the saliva and the volume of saliva at 8w 5. Scoring of immunological vigor, T lymphocyte age, the number of T cells, the ratio of CD4+/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, and the number of CD8+CD28+T cells at 8w | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The cumulative number of days and the maximum duration of the days with common cold symptoms* 2. The stool amount questionnaire at 8w 3. Each score of the MOS Short-Form 36-Item Health. Survey (SF-36) {Physical Component Summary (PCS), Mental Component Summary (MCS), Role-social Component Summary (RCS), Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, Mental Health} at 8w 4. The defecation frequency, the number of defecation days, the amount of defecation, stool shape, stool smell, and exhilarating feeling of defecation during the period of the test food consumption * 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