Healthy male/female adults
Conditions
Interventions
Consumption of test food 1 (2 capsules per day for 8 weeks)
Consumption of test food 2 (2 capsules per day for 8 weeks)
Sponsors
Metagen, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) At informed consent, male/female subjects aged more than or equal to 20, and less than 65 years old. (2) Defecation frequency is between 3 and 5 times a week. (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 products containing LAB (refers to those clearly indicated as ingredients, excluding those contained in the food as a result of the manufacturing process) from the time consent is obtained, or those who plan to consume such products during the study. (2) Subjects who are unable to discontinue consumption of foods for specified health uses, foods with function claims, health foods that may affect the study (intestinal regulation, etc.) from the time consent is obtained. (3) Subjects who are unable to discontinue consumption of supplements (including tablets, capsules, and other forms distinct from ordinary foodstuffs, taken for nutritonal or functional puposes regardless of ingredients or functionality) from the time consent is obtained. (4) Subjects who have taken drugs (antibiotics, antiflatulent, laxatives, etc.) that would affect the study one month prior to the pre-test, or those sho plant to take during the study. (5) Subjects with a history of appendectomy. (6) Subjects who have undergone surgery that may affect the study (colonoscopy, removal of gallstones or gall bladder, gastric bypass surgery, bariatric surgery, etc.) within 6 months prior to obtaining consent. (7) 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. (8) Subjects with extremely irregular eating habits. (9) Subjects whose roommates plan to participate in the study. (10) Smokers. (11) Heavy alcohol drinkers. (12) Subjects with a history of serious diseases of the heart, liver, kidneys, digestive organs, etc. (13) Pregnant, lactating, or intending to become pregnant during the study. (14) Subjects allergic to medicines and foods. (Due to character limitation, the following will be listed in the "Others" section)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Defecation frequency | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Defecation status (frequency, quantity, property, color, feeling of incomplete evacuation, abdominal pain, odor) 2. Gut microbiota 3. Gut metabolomes 4. Abdominal symptoms (bloating, belching, gas (flatus frequency)) at times other than during defecation | — |
Countries
Japan
Contacts
Public ContactFumiko Nakamura
CPCC Company Limited Clinical Support Division
Outcome results
None listed