Healthy male/female adults
Conditions
Interventions
Consumption of test sample (9 tablets per day for 4 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) 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 regularly take digestive enzyme products and are unable to discontinue consumption of the products 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 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. (6) 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. (7) Subjects with extremely irregular eating habits. (8) Subjects who have been diagnosed with kidney disease. (9) Subjects undergoing dialysis therapy. (10) Subjects with a history of serious diseases of the heart, liver, kidneys, digestive organs, etc. (11) Pregnant, lactating, or intending to become pregnant during the study. (12) Subjects allergic to medicines and foods. (13) Participating in a clinical study of another drug or health food, 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. (14) Those who are judged by the principal investigator to be inappropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gut microbiota/Gut metabolomes | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Defecation status (frequency, quantity, property, color, feeling of incomplete evacuation, abdominal pain, odor) 2. Abdominal symptoms (bloating, belching, gas (flatus frequency)) at times other than during defecation 3. Fecal cultivation assay - Cultivated microbiota - Cultivated metabolomes | — |
Countries
Japan
Contacts
Public ContactYuki Ishigaki
Amano Enzyme Inc. Carbohydrate and Food Processing Team, Development Dept.-I, Innovation Division
Outcome results
None listed