Healthy Japanese subjects
Conditions
Interventions
Duration: 2 weeks Test food: Tablets containing mulukhiya Administration: Take a total of 30 tablets per day between meals with water and no chewing
Duration: 2 weeks Test food: Placebo tablets Ad
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy subjects 2. Japanese adult subjects 3. Subjects who defecate three to five times per week 4. Subjects who do not eat enough fiber in usual dietary life 5. Subjects who are determined as eligible to participate in the study by the physician 6. Subjects who have relatively a few defecation frequencies at a week before screening (before consumption)
Exclusion criteria
Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure or myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Function Claims", or other functional food/beverage in daily 5. Subjects who are currently taking medications (including herbal medicines) and dietary supplements 6. Subjects who regularly use anticoagulants, such as warfarin 7. Subjects who are allergic to medicines and/or the test food related products 8. Subjects who are pregnant, breast-feeding, or planning to become pregnant 9. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial 10. Subjects who are ineligibility to participate in the study based on the evaluation of the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Defecation frequency *1 Record the bowel movement diary from a week before screening (before consumption) to the day before screening (before consumption) and from a week before consuming to the day before 4 weeks after consuming (total 3 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Defecation days 2. Amount of defecation 3. Shape of stool 4. Smell of stool 5. Exhilarating feeling 6. Bifidobacterium 7. Lactobacillales 8. Bacteroides 9. Prevotella 10. Clostridium cluster IV 11. Clostridium cluster IX 12. Clostridium cluster XI 13. Clostridium subcluster XIVa 14. Clostridium cluster XVIII 15. The Japanese version of Constipation Assessment Scale MT version (CAS-MT) 16. Bristol stool scale 17. Succinic acid 18. Lactic acid 19. Formic acid 20. Acetic acid 21. Propionic acid 22. iso-Butyric acid 23. n-Butyric acid 24. iso-Valeric acid 25. n-Valeric acid *1-5 Record the bowel movement diary from a week before screening (before consumption) to the day before screening (before consumption) and from a week before consuming to the day before 4 weeks after consuming (total 3 weeks) *6-25 Assess the measured values or the amount of change at screening (before consumption) and at 2 weeks after consumption | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed