Healthy Japanese subjects
Conditions
Interventions
Duration: Four weeks Test food: The test foods 1, 2, and 3 Administration: Morning: Take about 3 g of the test food 1, 6 g of the test food 2, and 30 mL of the test food 3 mixed with water (about
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 20 or more 4. Healthy subjects 5. Subjects who feels tired easily 6. Subjects who are judged as eligible to participate in the study by the physician 7. 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. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, 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 Function Claims," 5. Subjects who are currently taking medications (including herbal medicines) and supplements. 6. Subjects who are allergic to medicines and/or vegetables and fruits in general. 7. Subjects who are pregnant, lactation, or 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 diagnosed with pollen allergy 10. Subjects who have an autoimmune disease 11. Subjects who are taking immunosuppressants such as steroids 12. Subjects who have received vaccination for infectious diseases such as influenza within three month 13. Subjects who are diagnosed with hemoglobinemia (iron overload) 14. Subjects who are diagnosed with Wilson's disease 15. Subjects who are ineligibility to participate in the study based on the evaluation of the principal physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured values of scoring of immunological vigor at four weeks after consumption (4w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The amount of change of scoring of immunological vigor between screening (before consumption; Scr) and 4w 2. The measured values of immunological grade at 4w 3. The amount of change of immunological grade between Scr and 4w 4. The measured values of immunological vigor test*1 and intestinal flora*2 at 4w 5. The measured values of original questionnaires (the Likert scale method) at 4w 6. The amount of change of original questionnaires between Scr and 4w 7. The amount of change of immunological vigor test*1 and intestinal flora*2 between Scr and 4w 8. The ratio of subjects who were scored in each of the following items of immunological vigor at 4w: immunological grade, the score of T cells, the score of CD8+CD28+T cells, the score of ratio of CD4+/CD8+T cells, the score of naive T cells, the score of ratio of naive / memory T cells, the score of B cells, and the score of NK cells *1 immunological vigor test T lymphocyte age (upper limit), the score of T cells, the score of CD8+CD28+T cells, the score of ratio of CD4+/CD8+T cells, the score of naive T cells, the score of ratio of naive / memory T cells, the score of B cells, the score of NK cells, the number of T cells, the number of CD4+ cells, the number of CD8+ cells, the ratio of CD4+/CD8+T cells, the number of naive T cells, the ratio of naive / memory T cells, the number of B cells, the number of NK cells, the number of CD8+CD28+T cells *2 intestinal flora Bifidobacterium, Lactobacillales, Bacteroides, Prevotella, Clostridium cluster IV, Clostridium cluster IX, Clostridium clusterXI, Clostridium subcluster XIVa, Clostridium cluster XVIII | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed