Healthy Japanese
Conditions
Interventions
Duration: Four weeks Test product: Food containing bifidobacteria Administration: Consume two packets per day after breakfast with water, without chewing. *If you forget to consume the test produ
Sponsors
NAGASE BeautyCare Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy individuals 5. Individuals with bowel movement concerns 6. Individuals whose BMI is 18.5 kg/m2 or more and less than 23.0 kg/m2 7. Individuals whose defecation frequency is three to five times during the week before screening
Exclusion criteria
Exclusion criteria: 1. Individuals who are under treatment or have a history of malignant tumor, heart failure, or myocardial infarction 2. Individuals who have a pacemaker or an implantable cardioverter defibrillator 3. Individuals who are under 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 consume "Foods for Specified Health Uses" or "Foods with Functional Claims" 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 (particularly, milk, soybeans, or gelatin) 7. Individuals who have lactose intolerance 8. Individuals who are pregnant, lactating, or planning to become pregnant during this study 9. Individuals who consume foods/beverages considered to improve digestion (e.g., yogurt, lactic acid bacteria beverages, fermented foods) four or more days a week 10. Individuals who consume foods/beverages rich in dietary fiber four or more days a week 11. Individuals who consume high-protein foods/beverages (e.g., protein drinks) four or more days a week 12. Individuals who engage in intense exercise aimed at increasing muscle strength 13. Individuals who are restricting their diets or exercising for dieting 14. Individuals who drink pure alcohol an average of >= 60 g/day a week 15. Individuals who are smokers or have not yet completed one year since quitting smoking 16. Individuals who have irregular eating habits, sleep habits, or exercise habits 17. 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 18. Individuals who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Bifidobacteria in feces at four weeks after intervention (4w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Putrefactive products (p-cresol, phenol, 4-ethylphenol, indole, and skatole) in feces at 4w 2. Short-chain fatty acids (acetic acid, propionic acid, succinic acid, lactic acid, iso-butyric acid, iso-valeric acid, n-butyric acid, n-valeric acid, and formic acid) in feces at 4w 3. Defecation frequency, number of defecation days, defecation volume, stool form, stool odor, and exhilarating feeling of defecation in period 2-5* *Period 2: Days 1-7 after the start of intervention Period 3: Days 8-14 Period 4: Days 15-21 Period 5: Days 22-28 | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed