Male/female adults
Conditions
Interventions
Consumption of the test food (1 bottle a day) for 12 weeks
Consumption of the placebo food (1 bottle a day) for 12 weeks
Sponsors
CPCC Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females aged 20 to 59 years old. 2. Subjects whose body mass index (BMI) is included between 18.5 kg/m2 to less than 30.0 kg/m2 3. Subjects who take regular meals three times a day. 4. Subjects who can abstain from alcohol 2 days before each test. 5. Subjects who can give informed consent to partake in this research, after being provided with an explanation of the protocol detail.
Exclusion criteria
Exclusion criteria: 1. Subjects who regularly consume food products containing lactobacilli or bifidobacteria, foods fortified with oligosaccharides or dietary fiber, and health food products claimed to improve bowel movements or intestinal environment (including Food for Specified Health Uses (FOSHU) and Foods with Function Claims), and/or who cannot refrain from consuming these during the trial period. 2. Subjects who are unable to refrain from consuming large amounts of fermented foods such as natto or kimchi, other health foods, or sugar alcohol-containing foods like xylitol or erythritol. 3. Subjects who regularly use supplements or health foods (including Foods with Function Claims) that may affect immune function and cannot refrain from consuming these during the trial period. 4. Subjects with a past or present history of serious diseases including cardiac, hepatic, renal, gastrointestinal (including those with surgery affecting digestion and absorption), drug dependence, or alcohol dependence. 5. Subjects who regularly experience constipation and diarrhea alternately in their daily life. 6. Subjects with chronic diseases. 7. Subjects who are on regular medication. 8. Subjects who have taken antibiotics or other medications that could affect the intestinal environment or digestion and absorption on the day of the preliminary examination. 9. Subjects who consistently consume alcohol in amounts exceeding moderate drinking (approximately 20 g of pure alcohol per day). 10. Subjects who have extremely irregular dining habits, and subjects who have midnight work or irregular shift work. 11. Subjects who have smoking habit. 12. Subjects who are participating the other clinical tests. Subjects who participated within 4-weeks prior to the current study and/or who plan to participate the other clinical tests. 13. Subjects deemed unsuitable as study subjects based on blood tests conducted during the preliminary examination. 14. Subjects who are intolerant to lactose.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events and side effects. | — |
Countries
Japan
Contacts
Public ContactMakoto Ichinohe
CPCC Company Limited Clinical Planning Department
Outcome results
None listed