Effects of consumption of the test food on bowel movement in healthy Japanese
- Conditions
- Healthy Japanese
- Registration Number
- JPRN-UMIN000052608
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 44
Not provided
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 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 medications (including herbal medicines) and supplements 6. Individuals who are allergic to medicines and/or the test food related products 7. Individuals who have chronic constipation or diarrhea 8. Individuals who have other diseases that may significantly affect bowel movement, or who have a medical history of them 9. Individuals who are taking medicines, health foods, "Foods for Specified Health Uses," or "Foods with Functional Claims," that may affect bowel movement / take foods fortified with ingredients affecting bowel movement (e.g., fermented foods such as natto, kimchi, and pickles and foods fortified with dietary fiber) 10. Individuals who are pregnant, lactating, or planning to become pregnant during this study 11. 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 12. Individuals who are judged as ineligible to participate in this study by the physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. The defecation frequency in period 5* *Period 5: 22~28 days after consumption
- Secondary Outcome Measures
Name Time Method 1. The defecation frequency in period 2~4* 2. The numbers of defecation days and amount of defecation in period 2~5* 3. Stool shape, stool color, stool smell, and exhilarating feeling of defecation in period 2~5* 4. The Constipation Assessment Scale (CAS) score in the CAS Middle Term version (CAS-MT) at four weeks after consumption (4w) 5. Each item in the CAS-MT at 4w * Period 1: For 7 days prior to screening (before consumption) Period 2: For 7 days since initial consumption Period 3: 8~14 days after consumption Period 4: 15~21 days after consumption Period 5: 22~28 days after consumption