Healthy Japanese subjects
Conditions
Interventions
Duration: Eight weeks Test food: Sulforaphane glucosinolate powder Administration: Take one pack per day at any time during the day * Daily dose should be taken within the day.
Duration: Eight
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese adult subjects 2. Subjects who catch colds easily 3. Subjects who are judged as eligible to participate in the study by the physician 4. Subjects who have relatively low scoring of general health in SF-8 (SF8 Health Survey) at screening (before consumption)
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 are pollen allergy 5. Subjects who have a past or current medical history of respiratory disease 6. Subjects who have an autoimmune disease 7. Subjects who are taking immunosuppressants such as steroids 8. Subjects who have received vaccination for infectious diseases such as influenza 9. Subjects who have a vigorous exercise habit 10. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily 11. Subjects who take broccoli sprouts in daily 12. Subjects who are currently taking medications (including herbal medicines) and supplements 13. Subjects who are allergic to medicines and/or the test food related products 14. Subjects who are pregnant, breast-feeding, and planning to become pregnant 15. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial 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 | — |
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 percentage of subjects who have infected with the influenza virus during the intervention period 4. The measured values and changes from screening and advance examination of the following items at four and eight weeks after consumption: physical component summary (PCS), mental component summary (MCS), physical functioning, role physical, bodily pain, general health, social functioning, role emotional, 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, and salivary IgA | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed