Healthy Japanese
Conditions
Interventions
Duration: Eight weeks Test food: Beverage containing lactic acid bacteria Administration: Take one bottle per day (100 mL) *If you forget to take the test food, take it as soon as you remember. D
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 for seven days prior to Scr is 10 times or more and 20 times or less 6. Individuals whose defecation frequency which stool shape are classified as "slightly loose stool (5)" or "muddy stool (6)" in the Bristol stool scale are 50% or more of the total defecation frequency for seven days prior to Scr
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 3. Individuals who are undergoing treatment for any of cardiac arrhythmia, hepatopathy, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes, dyslipidemia, hypertension, or other chronic diseases 4. Individuals who take "Foods for Specified Health Uses (FOSHU)," or "Foods with Functional Claims (FFC)" 5. Individuals who take or use medicines (including herbal medicines) or supplements 6. Individuals who are allergic to medicines or foods related to the test product, especially bananas, peaches, Japanese pears, grapes, or other fruits 7. Individuals who are pregnant, lactating, or planning to become pregnant during this study 8. Individuals who suffer from diarrheal disease 9. Individuals who have had diarrhea for at least 2 weeks before agreeing to participate 10. Individuals who meet the diagnostic criteria for irritable bowel syndrome (IBS) or have already been diagnosed with IBS 11. Individuals who drink alcohol >20 g/day 12. Individuals who have other diseases that may substantially affect bowel movement 13. Individuals who usually take foods rich in lactic acid bacteria (LAB), or health foods (e.g. yogurt, drink, supplements) or medicines fortified with LAB 14. Individuals who usually take medicines, health foods, FOSHU, or FFC that may affect bowel movement/take foods fortified with ingredients affecting bowel movement (e.g. fermented foods such as natto, kimchi, or pickles, foods fortified with dietary fiber) 15. Individuals who cannot keep the test food refrigerated 16. Individuals who have been enrolled in other clinical studies within the last 28 days before agreeing to participate or plan to participate another study during this study 17. Individuals who are judged as ineligible to participate by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured value of defecation frequency in period 9* *Period 9: Seven days from the 50th day of intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured value of defecation frequency in period 2~8* 2. The measured values of number of days with defecation and amount of defecation in period 2~9* 3. The individuals whose stool shape, stool color, stool smell, and exhilarating feeling of defecation improved by at least one level in period 2~9 compared to period 1* 4. The individuals whose defecation frequency in period 9 is five times or more and nine times or less 5. The rate of defecation frequency which stool shapes are classified as "slightly loose stool," "muddy stool," or "watery stool" in period 9 and the individuals have less than 50% of the above defecation <Definition> (The number of "slightly loose stool," "muddy stool," or "watery stool" in period 9 / the defecation frequency in period 9) <0.5 6. The individuals whose defecation frequency in period 9 is five times or more and nine times or less and whose defecation frequency which stool shapes are classified as "slightly loose stool" or "muddy stool" are less than 50% of the total defecation frequency in period 9 7. The total score and each subscale of the Izumo Scale (Reflux, Pain, Fullness, Constipation, Diarrhea) at eight weeks after intervention (8w) 8. Shannon's diversity index, Observed operational taxonomic units (OTUs), Faith's Phylogenetic Diversity, and the abundance ratio of gut microbiota (Level 6: genus level) at 8w * Period 1: Seven days prior to screening (before intervention; Scr) Period 2: Seven days from the start of intervention Period 3: Seven days from the 8th day of intervention Period 4: Seven days from the 15th day of intervention Period 5: Seven days from the 22nd day of intervention Period 6: Seven days from the 29th day of intervention Period 7: Seven days from the 36th day of intervention Period 8: Seven days from the 43rd day of intervention Period 9: Seven days from the 50th day of in | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed