Healthy Japanese
Conditions
Interventions
Duration: Four weeks Test food: Capsule containing lactic acid bacteria Administration: Take one capsule per day with water *If you forget to take the test food, take it as soon as you remember.
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. Individuals aged 20 or more and less than 65 4. Healthy individuals
Exclusion criteria
Exclusion criteria: 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Individuals who are taking "Foods for Specified Health Uses," "Foods with Functional Claims," or "Foods with Nutrient Function Claims" 5. Individuals who are taking/using medications (including herbal medicines), internal quasi-drugs, and supplements 6. Individuals who are allergic to medicines and/or the test food related products 7. Individuals who are pregnant, lactating, or planning to become pregnant during this study 8. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate another study during this study 9. Individuals who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Individuals who experienced adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Individuals whose values of blood test and urinalysis are outside the reference range after intervention despite within the reference range at screening (before consumption) | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed