Healthy Japanese subjects
Conditions
Interventions
Duration: 2 weeks Test food: Manda Koso Administration: Take 5 packs per day after breakfast. Take the packs with water as necessary. * If you forget to take the test food, take it as soon as you
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese adult subjects who defecate three to five times per week 2. Subjects who are judged as eligible to participate in the study by the physician 3. Subjects who have relatively few defecation frequency 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 are allergic to medicines and/or the test food related products especially orange, walnut, sesame seeds, soybean, banana, and apple 7. Subjects who are pregnant, breast-feeding, or planning to become pregnant 8. 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 9. Subjects who are ineligibility to participate in the study based on the evaluation of the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Defecation days 2. Defecation frequency 3. Amount of defecation 4. Shape of stool 5. Smell of stool 6. Exhilarating feeling *1-6 Record the 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Firmicutes 2. Bacteroidetes 3. Actinobacteria 4. Proteobacteria 5. Lactobacillaceae 6. Bacteroidaceae 7. Lactobacillus 8. Clostridium 9. Roseburia 10. Ruminococcus 11. Eubacterium 12. Bifidobacterium 13. Bacteroides 14. Anaerostipes 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. Isobutyric acid 23. n-Butyric acid 24. Isovaleric acid 25. n-Valeric acid 26. Indole 27. Skatole *1-14 Analyze the intestinal environment by metagenomics *1-14 Calculate the abundance ratio of each bacterium *1-15, 17-27 Assess the measured value at screening (before consumption) and at 2 weeks after consumption and calculate the amount of change. *16 Assess the measured value 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