Healthy male/female adults
Conditions
Interventions
Consumption of the test food to the subject, 27 tablets a day for 4 weeks.
Consumption of the placebo food to the subject, 27 tablets a day for 4 weeks.
Sponsors
CPCC Company Limited
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. (2) Subjects who have a bowel evacuation for 3 to 7 times in a week. (3) Subjects who show understanding of the study procedures 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 trial start, which would affect the trial result. (2) Subjects who are regularly consuming food for specified health uses, food with function claims, supplement and/or health foods which would affects the trial results for more than 3 times a week. (3) Subjects who are regularly consuming mushrooms for not less than 6 days a week. (4) Subjects who have difficulty from restricting mushroom-intakes for less than 2 days a week, as well as less than 50 g a week. (5) Subjects who dislike mushrooms. (6) Subjects who had undergone appendectomy. (7) Subjects who have received the surgery which would affect the trial result within half a year before obtaining a consent. (8) Subjects who have previous/current medical history of severe cardiac, hepatic, renal or digestive diseases. (9) Pregnant, possibly pregnant, or lactating women. (10) Subjects who take excessive alcohol. (11) Subjects with irregular life style and irregular dietary habit. (12) Subjects who have food allergy. (13) Subjects who are planning to receive vaccination during this trial. (14) Subjects who are now under the other clinical tests with some kind of medicine/food, or took part in those within 4 weeks before this trial, or will join those after giving informed consent to participate in this trial. (15-17) 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. (18) Males who will be collected in total of their blood (1200 mL) within the last 12 months, after adding the blood amounts planning to be sampled in this trial. (19) Females who will be collected in total of their blood (800 mL) within the last 12 months, after adding the blood amounts planning to be sampled in this trial. (20) Others who have been determined ineligible by principal/sub investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fecal IgA level | — |
Secondary
| Measure | Time frame |
|---|---|
| Gut microbiota Gut metabolites Defecation status (the number of days, frequency, quantity, property, color, feeling of incomplete evacuation, abdominal pain, fecal odor) | — |
Countries
Japan
Contacts
Public ContactMakoto Ichinohe
CPCC Company Limited Clinical Planning Department
Outcome results
None listed