Healthy male/female adults
Conditions
Interventions
Group A: Consume 10 test foods per day
Group B: Consume 2 test foods per day
Sponsors
Metagen, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Male and female subjects, aged 20 to 64 years inclusive, at the time of informed consent. (2) Subjects with a bowel movement frequency of 3 to 5 times per week. (3) Subjects who have received a full explanation of the study, are capable of understanding the procedures, and have voluntarily provided written informed consent.
Exclusion criteria
Exclusion criteria: (1) Unable to comply with study dietary restrictions as specified in the "Prohibited/Restricted Food List". (2) Current, recent (within 4 weeks), or planned participation in another clinical trial. (3) Highly irregular lifestyle (e.g., night or rotating shifts). (4) Extremely irregular dietary habits. (5) Excessive alcohol consumption. (6) Current smoker or smoking within the past year. (7) Cohabiting with another study participant. (8) Anticipating significant life changes (e.g., moving, job transfer) during the study. (9) Use of medications affecting study outcomes (e.g., antibiotics, probiotics) within 1 month prior to or during the study. (10) Receiving continuous oral medication for a medical condition. (11) History of surgery potentially affecting study outcomes within 6 months prior to consent. (12) History of appendectomy. (13) History or current diagnosis of a severe cardiac, hepatic, renal, or digestive disease. (14) Pregnant, lactating, or planning pregnancy during the study. (15) Known allergies to drugs or foods. (16) Donation of blood components or 200 mL whole blood within 1 month prior. (17) Male with 400 mL whole blood donation within 3 months prior. (18) Female with 400 mL whole blood donation within 4 months prior. (19) Males whose 12-month total blood draw (including this study) would exceed 1200 mL. (20) Females whose 12-month total blood draw (including this study) would exceed 800 mL. (21) Deemed unsuitable for participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gut Microbiota | — |
Secondary
| Measure | Time frame |
|---|---|
| Gut metabolites Defecation status (including bowel movement frequency, number of days with bowel movements, stool volume, stool consistency, stool color, sensation of incomplete evacuation, abdominal pain during defecation, and odor) Abdominal symptoms between bowel movements (including bloating, borborygmus, and gas) Laboratory parameters | — |
Countries
Japan
Contacts
Public ContactFumiko Nakamura
CPCC Company Limited Clinical Support Division
Outcome results
None listed