Healthy Japanese
Conditions
Interventions
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 70 4. Individuals whose defecation frequency is three to five times in period 1
Exclusion criteria
Exclusion criteria: 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or 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" or "Foods with Functional Claims" 5. Individuals who are taking or using medications (including herbal medicines) and supplements 6. Individuals who do not take three meals daily: breakfast, lunch, and dinner 7. Individuals who are allergic to medicines and foods related to the test product 8. Individuals who are pregnant, lactating, or planning to become pregnant during this study 9. 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 in another study during this study 10. Individuals who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured value of defecation frequency in period 6* *Period 6: From 22 days after intervention to the day before at four weeks after intervention (4w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured values of defecation frequency in period 3~5* 2. Numbers of defecation days and amount of defecation in period 3~6* 3. Individuals whose stool shape, stool color, stool smell, and exhilarating feeling of defecation improved by one or more scales in period 3~6 compared to period 1* 4. Individuals whose stool shape, stool color, stool smell, and exhilarating feeling of defecation improved by one or more scales in period 3~6 compared to period 2* 5. The measured values of the occupancy rate of bacteria in the stool and the alpha diversity index at 4w *Period 1: For 7 days prior to screening (before intervention) Period 2: For 7 days prior to the start of the intervention Period 3: 1~7 days after intervention Period 4: 8~14 days after intervention Period 5: 15~21 days after intervention Period 6: From 22 days after intervention to the day before at 4w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed