Healthy subjects
Conditions
Interventions
Intake one bottle (100 mL) of test beverage a day, four continuous weeks.
Intake one bottle (100 mL) of control beverage a day, four continuous weeks.
Sponsors
CPCC Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females aged 20 to 64 years when informed consent. 2. Subjects who receive enough explain of the test, who deeply understanding of the test, and who obtain own consent to participate the test.
Exclusion criteria
Exclusion criteria: 1.Subjects who are given continuous treatment by taking medicines. 2.Subjects who have taken medicines that may have influence to intestinal environment from a month before advance inspection. 3.Subjects who constantly use food for specified health use, functional foods, supplements, and/or healthy food having a possibility of affecting intestine regulatory action. 4.Females who are pregnant or lactating, and females who could become pregnant or lactating during test period. 5.Subjects who have previous and/or current medical history of serious disease. 6.Subjects who excessive alcohol intake. 7.Subjects who have previous and/or current medical history of drug dependence, alcohol dependence. 8.Subjects who have extremely irregular dining habits, and subjects who have midnight work or irregular shift work. 9.Subjects who have previous medical history of drug and/or food, allergy, especially for milk and/or soybean milk. 10.Subjects who have constitution that tend to diarrhea if they intake dairy products and/or soybean milk products. 11.Subjects who are participating the other clinical tests, who participated within 4-weeks prior to the current study and/or who plan to participate the other clinical tests. 12.Subjects who donated over 200mL blood and/or blood components within the last one month. 13.Males who donated over 400mL blood and/or blood components within the last three month. 14.Females who donated over 400mL blood and/or blood components within the last four month. 15.Males who will be collected over 1200mL blood and/or blood components, when the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study. 16.Females who will be collected over 800mL blood and/or blood components when, the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study. 17.Others who have been determined ineligible by principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bacterial number and occupancy of Lactobacillus and Bifidobacterium | — |
Secondary
| Measure | Time frame |
|---|---|
| [Secondary outcomes] 1. Number of major intestinal bacteria in feces 2. Number of pathogenic bacteria in feces. 3. Constitution of microbiota in feces (such as occupancy of each bacteria, diversity of microbiota) 4. Recovery rate of Lactobacillus which contained in test beverage in feces 5. Organic acids of, moisture content of and pH of feces. 6. Spoilage product of and creatinine of urine 7. Stool frequency 8. Questionnaire about skin condition and OSA sleep inventory [Safety outcomes] Incidence of adverse events and of side effects | — |
Countries
Japan
Contacts
Public ContactMasanori Numa
CPCC Company Limited Planning & Sales Department
Outcome results
None listed