Healthy male/female adults
Conditions
Interventions
Consumption of the test food (1 pack a day, 4 weeks)
Consumption of the placebo food (1 pack a day, 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 60 years old. (2) Subjects who have a defection frequency 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 are taking food for specified health use, foods with functional claims, health foods, or supplements that may affect the intestinal environment more than 3 times/week and have been unable to discontinue them since the time of obtaining consent. (2) Subjects who are taking cocoa or foods with high cacao for more than 2 times/week and have been unable to discontinue them since the time of obtaining consent. (3) Subjects who take excessive alcohol. (4) Smoker (5) Subjects having an irregular life rhythm. (6) Subjects who are unable to maintain their lifestyle. (7) 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. (8) Subjects whose roomer is planning to join this trial. (9) Subjects who had undergone appendectomy. (10) Subjects who have received the surgery which would affect the trial result within half a year before obtaining a consent. (11) Subjects who have a plan or who have taken medication within a month before the pre-test start, which would affect the intestinal environment. (12) Subjects who have previous/current medical history of severe cardiac, hepatic, renal or digestive diseases. (13) Pregnant, possibly pregnant, or lactating women. (14) Subjects who are allergic to medicines and test foods. Subjects who donated their blood components, and/or whole blood as below (15) all subjects: 200 mL within a month (16) males: 400 mL within the last 3 months (17) females: 400 mL within the last 4 months to this trial. Subjects whose collected blood volume within the last 12 months would reach to the following criteria after adding the blood collection in this study; (18) males: 1,200 mL (19) females: 800 mL (20) Others who have been determined ineligible by the principal/sub investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Defecation frequency | — |
Secondary
| Measure | Time frame |
|---|---|
| Defecation status CAS-MT | — |
Countries
Japan
Contacts
Public ContactFumiko Nakamura
CPCC Company Limited Clinical Support Division
Outcome results
None listed