Healthy Japanese subjects
Conditions
Interventions
Duration: 12 weeks Test food: Nucleotide containing capsule Administration: Take two capsules per day at breakfast with water *If you forget to take the test food, take it as soon as you remember
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. Subjects aged 50 or more 4. Healthy subjects 5. Subjects who have one or more days with common cold symptoms in the week prior to screening (before consumption; Scr) 6. Subjects who have low scoring of immunological vigor at Scr
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 currently undergoing treatment for pollen allergy or allergic rhinitis 5. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily 6. Subjects who are currently taking medications (including herbal medicines) and supplements 7. Subjects who are allergic to medicines and/or the test food related products 8. Subjects who are pregnant, lactating, or planning to become pregnant during this trial 9. Subjects who are smokers or have quit smoking within the last year before the agreement to participate in this trial 10. Subjects who suffer from COVID-19 11. Subjects who have received vaccination for influenza within the last seven days before the agreement to participate in this trial 12. 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 13. Subjects who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The cumulative number of onset days with common cold symptoms per subject | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The maximum duration of the days with common cold symptoms per subject 2. The cumulative number of onset days and the maximum duration of the days with whole body malaise, chilliness, feverishness, fatigue, sneezing, nasal discharge, blocked nose, throat pain, cough, joint pain, muscle pain, and headache per subject 3. The cumulative number of onset days with common cold symptoms, whole body malaise, chilliness, feverishness, fatigue, sneezing, nasal discharge, blocked nose, throat pain, cough, joint pain, muscle pain, and headache per group 4. Scoring of immunological vigor at 12 weeks after consumption (12w) 5. Immunological grade at 12w 6. T lymphocyte age (upper limit and lower limit) at 12w 7. Scoring of following items: number of T cells, number of CD8+CD28+ T cells, CD4+T cells / CD8+T cells ratio, number of naive T cells, naive T cells / memory T cells ratio, number of B cells, and number of natural killer (NK) cells at 12w 8. Number of T cells, CD4+ T cells / CD8+ T cells ratio, number of naive T cells, naive T cells / memory T cells ratio, number of B cells, number of NK cells, number of CD8+CD28+ T cells, number of CD4+ T cells, number of CD8+ T cells, number of memory T cells, percentage of T cells, percentage of CD4+ T cells, percentage of CD8+ T cells, percentage of naive T cells, percentage memory T cells, percentage of CD56+16- NK cells, percentage of CD56+16+ NK cells, percentage of B cells, percentage of CD8+CD28+ T cells, secretary immunoglobulin A (sIgA) in the saliva, and NK cell activity at 12w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed