Healthy Japanese subjects
Conditions
Interventions
Duration: Eight weeks Test food: Brolico Administration: Take six capsules per day in the morning *If you forget to take the test food, take it as soon as you remember. Daily dose should be taken
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 catch colds easily
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 diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily 5. Subjects who are currently taking medications (including herbal medicines) and supplements 6. Subjects who are allergic to medicines and/or the test food related products 7. Subjects who are pregnant, lactating, or planning to become pregnant during this trial 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 have a history of salivary glands treatment 13. Subjects who use immunosuppressants such as steroid 14. Subjects who have received vaccination for influenza within the last three months 15. Subjects who have an exercise habit with 4.0 METs or more (such as vigorous running) 16. Subjects who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Plasmacytoid dendritic cells (pDC) activity at eight weeks after consumption | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The cumulative number of days with common cold symptoms (*) during the intervention period per subject 2. The maximum duration of the 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 | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed