Healthy Japanese subjects
Conditions
Interventions
Duration: Four weeks Test beverage: Fermented soy milk with lactic acid bacteria Administration: Take one test beverage per day at any time during the day * Daily dose should be taken within the
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 catch colds 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," or other functional food/beverage in daily 5. Subjects who are currently taking medications (including herbal medicines) and supplements. 6. Subjects who are allergic to medicines and/or the test beverage related products. 7. Subjects who are pregnant, lactation, or planning to become pregnant 8. 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 enroll in another clinical trial during trial period 9. Subjects who are diagnosed with pollen allergy 10. Subjects who are smokers 11. Subjects who have a past or current medical history of respiratory disease 12. Subjects who have an autoimmune disease 13. Subjects who have a history of salivary glands treatment 14. Subjects who are taking immunosuppressants such as steroids 15. Subjects who have received vaccination for infectious diseases such as influenza within three month 16. Subjects who are ineligibility to participate in the study based on the evaluation of the principal physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The measured values of scoring of immunological vigor at four weeks after consumption (4w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured values of scoring of immunological vigor at two weeks after consumption (2w) 2. The amount of change of scoring of immunological vigor between screening (before consumption; Scr) and 2w, or 4w 3. The measured values of following items at 2w and 4w: T lymphocyte age (upper limit), 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, salivary IgA, and the items of MOS Short-Form 36-Item Health Survey {SF-36; physical component summary (PCS), mental component summary (MCS), role component summary (RCS), physical functioning, role physical, bodily pain, general health, activity, social functioning, role emotional, and mental health} 4. The amount of changes of following items between Scr and 2w, or 4w: T lymphocyte age (upper limit), 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, salivary IgA, and the items of SF-36 (PCS, MCS, RCS, physical functioning, role physical, bodily pain, general health, activity, social functioning, role emotional, and mental health) 5. The number of subjects who were scored in each of the following items of immunological vigor at 2w and 4w: immunological grade, 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, and the score of NK cells | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed