Healthy male/female adults
Conditions
Interventions
Consumption of the test food 1 (1 meal per day at lunch for 4 weeks)
Consumption of the test food 2 (1 meal per day at lunch for 4 weeks)
Consumption of the test food 3 (1 meal per day at lunch for 4
Sponsors
Metagen, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects whose defecation frequency are more than 3 times per week. 2. Subjects who eat only the test food for lunch and have no problem drinking all the soup. 3. Subjects who can show their understanding of the study procedure and agreement with participating in the study by informed consent prior to the study.
Exclusion criteria
Exclusion criteria: 1. Subjects who are unable to discontinue consumption of instant noodles (cup ramen, cup yakisoba, bagged noodles, frozen noodles, chilled noodles, noodles sold in convenience stores, etc.) from the day of the preliminary test. 2. Subjects who are unable to discontinue consumption of foods for specified health uses, foods with function claims, health foods (including supplements) that may affect the study (intestinal regulation, etc.) from the day of the preliminary test. 3. Subjects who are participating in a clinical study of another drug or health food, or within 4 weeks of the completion of the study, or who is scheduled to participate in another clinical study after consent to participate in this study. 4. Subjects with extremely irregular lifestyles (late-night work, shift work, etc.). 5. Subjects with extremely irregular eating habits. 6. Heavy alcohol drinkers. 7. Smokers. 8. Subjects whose roommates plan to participate in the study. 9. Subjects who are expected to undergo a major change in their family, work, or other living environment (e.g., relocation, transfer, etc.) during the study. 10. Subjects who have taken drugs (antibiotics, antiflatulent, laxatives, etc.) that would affect the study, one month prior to the preliminary test, or during the study. 11. Subjects who have undergone surgery that may affect the study (colonoscopy, removal of gallstones or gallbladder, gastric bypass surgery, etc.) within 6 months prior to obtaining consent. 12. Subjects with a history of appendectomy. 13. Subjects with diabetes mellitus, hyperpiesia or dyslipidemia. 14. Subjects with a history of serious diseases of the heart, liver, kidneys, digestive organs, etc. 15. Females who are pregnant, lactating, or intending to become pregnant during the study. 16. Subjects allergic to medicines and foods. 17. Subjects who are aware of excessive salt in their daily diet. (Due to character limitation, the following will be listed in the "Others" section)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gut microbiota | — |
Secondary
| Measure | Time frame |
|---|---|
| Gut metabolomes Gut putrefactive compounds Defecation status (frequency, quantity, property, color, feeling of incomplete evacuation, abdominal pain, odor) Abdominal symptoms (bloating, belching, gas) at times other than during defecation Clinical laboratory test values | — |
Countries
Japan
Contacts
Public ContactFumiko Nakamura
CPCC Company Limited Clinical Support Division
Outcome results
None listed