Male/female adults
Conditions
Sponsors
CPCC Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese men and women aged 20 to below 65 years at the time of consent acquisition. 2. Subjects who have had an average bowel movement frequency of 5 times or less per week for the two months prior to consent acquisition. 3. Subjects who can give informed consent to partake in this study, after being provided with an explanation of the protocol detail.
Exclusion criteria
Exclusion criteria: 1. Subjects who consume Foods for Specified Health Uses (FOSHU), Foods with Functional Claims, or health supplements (including those with effects on intestinal regulation, probiotics, or prebiotics) three or more times per week that could potentially affect the study. 2. Subjects who cannot stop consuming Foods for Specified Health Uses (FOSHU), Foods with Functional Claims, or health supplements (including those with effects on intestinal regulation, probiotics, or prebiotics) that could potentially affect the study from the time of consent acquisition. 3. Subjects who have taken medications that could affect the study (such as antibiotics, intestinal regulators, or laxatives) within one month before consuming the study food, or those who plan to take such medications during the study period. 4. Subjects who cannot abstain from alcohol from the day before the preliminary examination or each test. 5. Subjects with excessive alcohol intake. 6. Smokers or Subjects who have quit smoking within the last six months. 7. Subjects with gastrointestinal diseases or a history of gastrointestinal surgery (excluding hemorrhoid surgery) that could affect digestion and absorption. 8. Subjects currently taking medication for lifestyle-related diseases or other treatments. 9. Subjects receiving medical treatments such as dialysis, exercise therapy, or dietary therapy. 10. Subjects with irregular life rhythms (such as shift workers or night shift workers). 11. Subjects planning to travel or move for 3 nights and 4 days or more during the study period. 12. Subjects who are participating in the other clinical trials and/or who have participated in the other clinical trials within 4 weeks prior to the current trial and/or who are planning to participate in the other clinical trials. 13. Females who are pregnant or lactating, and females who could become pregnant during trial period. 14. Subjects with self-reported irritable bowel syndrome (IBS).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of bowel movements | — |
Secondary
| Measure | Time frame |
|---|---|
| Bowel movement conditions (stool consistency, abdominal symptoms) Gut microbiota composition Gut metabolites Intestinal barrier markers Profile of Mood States 2nd Edition (POMS2) Short Form | — |
Countries
Japan
Contacts
Public ContactMakoto Ichinohe
CPCC Company Limited Clinical Planning Department
Outcome results
None listed