Effects of the test food on the bowel movement in healthy Japanese subjects
- Conditions
- Healthy Japanese subjects
- Registration Number
- JPRN-UMIN000051046
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 56
Not provided
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 diseases: 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 take yogurt, lactic acid bacteria beverages, or natto at least four times a week 6. Subjects who are currently taking medications (including herbal medicines) and supplements 7. Subjects who are allergic to medicines and/or the test food related products 8. Subjects who are allergic to grapefruit or citrus fruits 9. Postmenopausal women 10. Subjects who are pregnant, lactating, or planning to become pregnant during this trial 11. 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 12. Subjects 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 III* *Period III: The 2nd week after consumption of the test food
- Secondary Outcome Measures
Name Time Method 1. The defecation frequency in period II* 2. The numbers of defecation days and amount of defecation in period II and III* 3. The rate of each state for stool shape, stool smell, and exhilarating feeling of defecation in period II and III* 4. The score of the Japanese Version of the Constipation Assessment Scale [middle term] (CAS-MT) at two weeks after consumption (2w) 5. Each item of CAS-MT at 2w 6. The intestinal flora at 2w * Period I: Seven days prior to screening (before consumption: Scr) Period II: The 1st week after consumption of the test food Period III: The 2nd week after consumption of the test food