Healthy Japanese
Conditions
Interventions
Duration: Eight weeks Test food: Oryza Ceramide (R)-PCD Administration: Take one capsule per day after breakfast. *If you forget to take the test food, take it as soon as you remember. Daily dose
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 individuals 5. Individuals who are aware of catching colds easily
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) and supplements 6. Individuals who are allergic to medicines and foods related to the test food 7. Individuals who are pregnant, lactating, or planning to become pregnant during this study 8. 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 9. Individuals who have received vaccination for influenza within the last three months 10. Individuals who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured value of immunoglobulin A (IgA) in the stool at eight weeks after consumption (8w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured value of IgA in the stool at four weeks after consumption (4w) 2. The logarithmic value of IgA in the stool at 4w and 8w 3. The measured value and logarithmic value of secretory IgA (sIgA) in the saliva at 4w and 8w 4. The cumulative number of days with common cold symptoms and each symptom (rhinorrhea / nasal discharge: yellow secretion, rhinorrhea / nasal discharge: bloody secretion, nasal congestion, sneezing, sore throat, hoarseness, cough, headache, malaise, muscle pain, diarrhea, nausea, vomiting) during this study period per individual 5. The measured values of acetic acid, propionic acid, iso-butyric acid, n-butyric acid, iso-valeric acid, n-valeric acid, lactic acid, succinic acid, and formic acid at 4w and 8w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed