Healthy Japanese subjects
Conditions
Interventions
Duration: Four weeks Test food: Food containing lactic acid EF-2001 strain (1.3 x 1012 cells) Administration: Take one packet with water two times a day each after breakfast and dinner * Daily d
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Women 3. Subjects aged 30 or more and less than 50 4. Healthy subjects 5. Subjects who easily feel tired and catch colds 6. Subjects whose scoring of immunological vigor are between 14 and 20 at screening (before consumption; Scr) 7. Subjects whose scoring of immunological vigor are relatively low 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 disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily 5. Subjects who currently taking medications (including herbal medicines) and supplements 6. Subjects who are allergic to medicines and/or the test food related products 7. Subjects who are pregnant, lactation, or planning to become pregnant 8. Subjects who suffer from COVID-19 9. 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 10. Subjects who are judged as ineligible to participate in the study by the physician 11. Subjects whose working hours are irregular 12. Subjects whose ifestyles are irregular (such as dietary habits, exercise habits, and sleeping habits) 13. Subjects who have autoimmune disease 14. Subjects who are taking immunosuppressants such as steroids 15. Subjects who have perennial allergic rhinitis 16. Subjects who are currently undergoing treatment of insomnia or sleep disorder 17. Subjects who are smokers 18. Subjects who have lactose intolerance 19. Subjects who have a medical history or history of present illness of immunodeficiency, severe bowel disease, valvular heart disease, or hepatic cirrhosis 20. Subjects who are undergoing central venous catheterization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Scoring of immunological vigor | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. T lymphocyte age, the rate of CD3+T cells, the number of CD3+T cells, the score of CD3+T cells, the rate of CD4+T cells, the number of CD4+T cells, the rate of CD8+T cells, the number of CD8+T cells, the rate of naive T cells (CD4+), the number of naive T cells (CD4+), the score of naive T cells (CD4+), the rate of memory T cells (CD4+), the number of memory T cells (CD4+), the score of memory T cells (CD4+), CD8+CD28+ T cells, the rate of B (CD20+) cells, the number of B cells (CD20+), the score of B cells (CD20+), the rate of NK cells (CD56+CD16-), the rate of NK cells (CD56+CD16+), the rate of NK cells (CD56-CD16+), the number of NK cells, the score of NK cells, the ratio of CD4+/CD8+T cells, the score of ratio of CD4+/CD8+T cells, the ratio of naive T cells to memory T cells, the score of ratio of naive T cells to memory T cells, and immunological grade 2. An original questionnaire measured by Likert scale (1. "I have a tendency to constipation", 2. "I am concerned about stool smell", 3. "I am concerned about body odor", 4. "I am concerned about halitosis", 5. "My skin is dry", 6. "I am concerned about skin condition", 7. "My waist is tight", 8. "My body is heavy", 9. "I feel stress", and 10. "I am easily tired") | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed