Healthy Japanese subjects
Conditions
Interventions
Duration: Eight weeks Test food: Active capsule Administration: Take one capsule per day at any time during the day. *If you forget to take the test food, take it as soon as you remember within t
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. Subjects aged 20 or more 4. Healthy subjects 5. Subjects who are prone to catching colds 6. Subjects who are judged as eligible to participate in the study by the physician 7. Subjects who have low scoring of immunological vigor at Scr
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 under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or 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 medicines and/or the test food related products 7. Subjects who are pregnant, breast-feeding, and planning to become pregnant 8. 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 9. Subjects who are smokers 10. Subjects who have a past or current medical history of respiratory disease 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 are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The common cold symptoms during the intervention period per subject | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured values and amount of change from screening (before consumption: Scr) in each of the following items at four weeks (4w) and eight weeks (8w) after consumption: scoring of immunological vigor, immunological grade, T lymphocyte age (upper limit), number of T cells, CD4+T cells / CD8+T cells ratio, number of naive T cells, naive T cells / memory T cells ratio, number of B cells, number of NK cells, number of CD8+CD28+T cells, NK cell activity, the items of MOS Short-Form 36-Item Health Survey {SF-36; physical component summary (PCS), mental component summary (MCS), role component summary (RCS), physical functioning, role physical, bodily pain, general health, social functioning, role emotional, and mental health}, interleukin-8 (IL-8), interferon-gamma (IFN-gamma), and tumor necrosis factor-alpha (TNF-alpha) 2. Scoring of T cells, CD8+CD28+T cells, CD4+T cells / CD8+T cells ratio, number of naive T cells, naive T cells / memory T cells ratio, number of B cells, number of NK cells at 4w and 8w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed