Healthy male/female adults
Conditions
Interventions
Consumption of any of test food No. 1 to 5 with milk 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) Subjects who are members of Calomama app. (3) Subjects who get into a habit of having breakfast, and will be able to replace their breakfast by the test food. (4) Subjects who can collect and send fecal samples to the analysis agency. (5) 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 medication within a month before the pre-test start, which would affect the intestinal environment. (2) Subjects who had undergone appendectomy. (3) Subjects who have received the surgery which would affect the trial result within half a year before obtaining a consent. (4) Subjects who are now under other clinical tests with some kind of medicine/food, or participated in those within 4 weeks before this trial, or will join those after giving informed consent to participate in this trial. (5) Subjects having an irregular meal rhythm. (6) Subjects who take excessive alcohol. (7)Subjects whose roomer is planning to join this trial. (8) Subjects who are planning to change their life style considerably during this trial. (9) Subjects who cannot drink milk. (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 with lactose intolerance. (13) Subjects who have food allergies. (14) Others who have been determined ineligible by principal/sub investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gut metabolites | — |
Secondary
| Measure | Time frame |
|---|---|
| Gut microbiota Defecation status POMS2 Athens Insomnia Scale | — |
Countries
Japan
Contacts
Public ContactMakoto Ichinohe
CPCC Company Limited Clinical Planning Department
Outcome results
None listed