Healthy Japanese subjects
Conditions
Interventions
Duration: 4 weeks Test food: Plant-origin nano-sized lactic acid bacterium SNK 150 mg (3x1011) Administration: Take 1 packet per day with water in the morning * If you forget to take the test foo
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 are judged as eligible to participate in the study by the physician 6. Subjects who are judged as eligible to participate in the study by the physician according to the scores of Beck depression inventory (BDI)-II 7. Subjects whose Total Mood Disturbance (TMD) score of POMS2 are relatively high at screening
Exclusion criteria
Exclusion criteria: 1. Subjects who are undergoing medical treatment or have at least one previous medical history of malignant tumor, heart failure, myocardial infarction, mental disorder, immunodeficiency, short bowel syndrome, ulcerative colitis, valvular heart disease or bowel obstruction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects who are currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or 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 currently taking medicines (include herbal medicines) and supplements 6. Subjects who are allergic to medicines and/or the test food related products 7. Subjects who are pregnant, breast-feeding, or planning to become pregnant during the trial 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 have irregular sleeping hours and habits due to night shifts, etc. 10. Subjects who are smokers 11. Subjects who have infant children 12. Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Profile of Mood States 2nd Edition (POMS2) Japanese version | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Visual analogue scale (VAS) 2. Test of autonomic nervous system 3. Saliva test 4. Oguri-Shirakawa-Azumi sleep inventory version MA (OSA-MA) | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed