Healthy Japanese
Conditions
Interventions
Duration: Four weeks Test food: L-arabinose Administration: Measure 3 g with prescribed spoon and dissolve it in 150 mL of water (about a cupful). And then drink it before the meal. Repeat the above
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. Adults 4. Healthy individuals 5. Individuals whose defecation frequency is three to five times per week
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The defecation frequency in period 5* *Period 5: 22~28 days after consumption | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed