Healthy male/female adults
Conditions
Interventions
Consumption of the test food (4 capsules per day) every day for 4 weeks.
Consumption of the test food (4 capsules per day) every day for 4 weeks.
Consumption of the test food (4 capsules per day) ever
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 have a bowel evacuation for 3 to 5 times in a week (3) Subjects who can show their understanding of the study procedure and agreement with participating in the study by written informed consent prior to the study.
Exclusion criteria
Exclusion criteria: (1) Subjects who have a plan or who have taken the food containing lactic acid bacteria within a month before the trial start, which would affect the trial result. (2) Subjects who are regularly consuming foods for specified health uses, foods with function claims, supplement and/or health foods, which would affect the trial results for more than 3 times a week. (3) Subjects who have a plan or who have taken medication within a month before the pre-test start, which would affect the trial result. (4) Subjects who had undergone appendectomy. (5) Subjects who have received the surgery which would affect the trial result within half a year before obtaining a consent. (6) Subjects who are expected to undergo major changes in their living environment such as home and work during this trial. (7) Subjects with irregular dietary habits. (8) Subjects whose roomer is planning to join this trial. (9) Subjects who take excessive alcohol. (10) Subjects who have previous/current medical history of severe cardiac, hepatic, renal or digestive diseases. (11) Pregnant, possibly pregnant, or lactating women. (12) Subjects who are allergic to medicines and test foods (related to lactic acid bacteria). (13) Subjects who are now under other clinical tests with some kind of medicine/food, or participated in those within a month before this trial, or will join those after giving informed consent to participate in this trial. (14-16) Subjects who donated their blood components, and/or whole blood as below - all subjects: 200 mL within a month - males: 400 mL within the last 3 months - females: 400 mL within the last 4 months to this trial. (17-18) Subjects whose collected blood volume within the last 12 months would reach to the following criteria after adding the blood collection in this study; - males: 1,200 mL - females: 800 mL (19) Others who have been determined ineligible by the principal/sub investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Defecation frequency | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Gut microbiota 2. Gut metabolites 3. Defecation status (the number of days, quantity, property, color, feeling of incomplete evacuation, abdominal pain, fecal odor) 4. Abdominal symptoms (bloating, borborygmus, gas) at times other than defecation 5. Changes in laboratory values, adverse events and side effects | — |
Countries
Japan
Contacts
Public ContactShinnosuke Murakami
Metagen, Inc. Headquarters
Outcome results
None listed