Healthy Japanese subjects
Conditions
Interventions
Duration: four weeks Test food: Capsule containing 100 mg of lactic acid bacteria Administration: Take two capsules once a day between meals. *If you forget to take the test food, take it as soon
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese adult subjects 2. Subjects who are prone to catching colds 3. Subjects who are judged as eligible to participate in the study by the physician 4. Subjects who have low scoring of immunological vigor at screening
Exclusion criteria
Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, short bowel syndrome, 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 disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily use 5. Subjects who are currently taking medications (including herbal medicines) and supplements 6. Subjects who are allergic to medicines and/or the test food-related products, or pollen 7. Subjects who are pregnant, lactating, 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 participate another trial during this trial 9. Subjects who are smokers 10. Subjects who have had a medical treatment for their salivary gland or intestine 11. Subjects who have received vaccination for infectious diseases such as influenza within a year 12. Subjects who are allergic to dairy-related product 13. Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The measured value of scoring of immunological vigor at four weeks after consumption (4w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured values of following items at 4w: immunological grade, T lymphocyte age (upper limit), 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, the score of NK cells, 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, and salivary IgA, 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 2. The amount of changes of following items between screening (before consumption) and 4w: scoring of immunological vigor, immunological grade, T lymphocyte age (upper limit), 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, the score of NK cells, 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, and salivary IgA, PCS, MCS, RCS, physical functioning, role physical, bodily pain, general health, activity, social functioning, role emotional, and mental health 3. The cumulative number of days with common cold symptoms (nasal discharge, blocked nose, throat pain, cough, whole body malaise, joint pain, and chilliness) during the intervention period per group | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed