Healthy Japanese
Conditions
Interventions
Duration: Two weeks Test food: Test food A
Duration: Two weeks Test food: Test food B
Sponsors
Central Research Institute, ITO EN, LTD.
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 in Period 1 6. Individuals whose defecation frequency is three to five times per week in Period 2
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) or supplements 6. Individuals who are allergic to medicines or foods related to the test product, particularly those with allergies to burdock, barley, or wheat 7. Individuals who regularly take grapes, wine, grape juice, or polyphenol-rich foods or beverages (such as cacao, citrus fruits, or black tea) 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 4* *Period 4: 8~14 days after intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The change from period 2* of defecation frequency in period 4 2. The measured value and change from period 2 of defecation frequency in period 3* 3. The measured value and the change from period 1*-2 of defecation frequency in period 3-4 4. The measured values and changes from period 2 of numbers of defecation days and amount of defecation in period 3 and 4 5. The measured values and changes from period 1-2 of numbers of defecation days and amount of defecation in period 3-4 6. Individuals whose stool shape, stool smell, and exhilarating feeling of defecation improved by one or more scales in period 3 compared to period 2 7. Individuals whose stool shape, stool smell, and exhilarating feeling of defecation improved by one or more scales in period 4 compared to period 2 8. Individuals whose stool shape, stool smell, and exhilarating feeling of defecation improved by one or more scales in period 3-4 compared to period 1-2 9. The measured value and change from screening (before intervention; Scr) of the Constipation Assessment Scale (CAS) score in the CAS Middle Term version (CAS-MT) at two weeks after intervention (2w) 10. Individuals whose response to an original questionnaire improved by one or more scales at 2w compared to Scr *Period 1: 14~8 days before Scr Period 2: 7 days before Scr Period 3: For 7 days since the first intervention | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed