Healthy Japanese
Conditions
Interventions
Duration: 8 weeks Test product: Gamma-oligosaccharide inclusion complex of Brazilian green propolis supercritical extract (low dose) Administration: Consume four tablets daily with water after the f
Sponsors
Fujimi Beehouse Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy individuals
Exclusion criteria
Exclusion criteria: 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction 2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 5. Individuals who are taking or using medications (including herbal medicines) or supplements 6. Individuals who are allergic to medicines or foods related to the test product 7. Individuals with suspected asthma 8. Individuals who are pregnant, lactating, or planning to become pregnant during this study 9. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study 10. Individuals who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Measured value of the immunological vigor score at 8 weeks after intervention (8w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Cumulative number of days with cold-like symptoms, maximum duration, and number of onset occurrences per participant during the study period 2. Number of participants exhibiting cold-like symptoms during the study period 3. Cumulative number of days, maximum duration, number of onset occurrences, and severity of general malaise, chills, feverishness, fatigue, sneezing, runny nose, nasal congestion, sore throat, cough, joint pain, muscle pain, and headache for each participant during the study period 4. Number of participants exhibiting general malaise, chills, feverishness, fatigue, sneezing, runny nose, nasal congestion, sore throat, cough, joint pain, muscle pain, and headache during the study period 5. Immunological vigor grade, T lymphocyte age (lower limit), T lymphocyte age (upper limit), CD3+ T cell percentage, CD3+ T cell count, CD3+ T cell count score, CD4+ T cell percentage, CD4+ T cell count, CD8+ T cell percentage, CD8+ T cell count, CD4+ T cell count/CD8+ T cell count ratio, CD4+ T cell count/CD8+ T cell count ratio score, naive T cell percentage, naive T cell count, naive T cell count score, memory T cell percentage, memory T cell count, naive T cell count/memory T cell count ratio, naive T cell count/memory T cell count ratio score, CD56+16- natural killer (NK) cell percentage, CD56+16+ NK cell percentage, NK cell count, NK cell count score, B cell percentage, B cell count, B cell count score, CD8+CD28+ T cell percentage, CD8+CD28+ T cell count, and CD8+CD28+ T cell count score at 8w 6. Relative abundance of fecal bacteria and alpha diversity index at 8w 7. Measured values of white blood cell count (WBC), white blood cell differential (neutrophil percentage, lymphocyte percentage, monocyte percentage, eosinophil percentage, and basophil percentage) at 8w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed