Healthy Japanese subjects
Conditions
Interventions
Duration: Eight weeks Test food: Brolico Administration: Take six capsules per day in the morning * Daily dose should be taken within the day. 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 catch colds easily 6. Subjects who are judged as eligible to participate in the study by the physician 7. Subjects who have relatively low NK cell activity at screening
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 disease: 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," "Foods with Functional Claims," or other functional food/beverage 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, 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 an autoimmune disease 12. Subjects who have a history of salivary glands treatment 13. Subjects who are taking immunosuppressants such as steroids 14. Subjects who have received vaccination for infectious diseases such as influenza within the last three months 15. Subjects who have an exercise habit with 4.0 Metabolic Equivalent (MET)s or more (such as vigorous running) 16. Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 cumulative number of days with common cold symptoms (*) during the intervention period per group 3. The measured values and changes from screening of the following items at eight weeks after consumption: each item of MOS Short-Form 36-Item Health Survey (SF-36) [physical component summary (PCS), mental component summary (MCS), physical functioning, role physical, bodily pain, general health, social functioning, role emotional, and mental health], 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, NK cell activity and salivary IgA | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed