A verification study of the improving effect of bowel movement by the test food consumptio
- Conditions
- Healthy Japanese subjects
- Registration Number
- JPRN-UMIN000047850
- 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 who currently undergoing treatment for any of the following chronic disease: 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 currently taking medications (including herbal medicines) and supplements 6. Subjects who are allergic to medicines and/or the test food related products 7. Subjects who are pregnant, lactation, or planning to become pregnant 8. Subjects who suffer from COVID-19 9. 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 10. Subjects who are judged as ineligible to participate in the study by the physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Defecation frequency at the 2nd week after consumption of the test food
- Secondary Outcome Measures
Name Time Method 1. Defecation frequency at the 1st week after consumption of the test food 2. Numbers of defecation days and amount of defecation at the 1st and 2nd week after consumption of the test food 3. Stool shape, stool smell, and exhilarating feeling of defecation at the 1st and 2nd week after consumption of the test food 4. The score of The Japanese Version of the Constipation Assessment Scale (CAS) 5. Each item of CAS 6. Bifidobacterium, Lactobacillales order, Bacteroides, Prevotella, Clostridium cluster IV, Clostridium cluster IX, Clostridium cluster XI, Clostridium subcluster XIVa, Clostridium cluster XVIII