None
Conditions
Interventions
Consume 30 g/day of test food for 4 weeks
Consume 30 g/day of control for 4 weeks
Sponsors
Metagen, Inc.
SHOKUNOCHIKARA CORP.
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 written informed consent prior to the study
Exclusion criteria
Exclusion criteria: (1) Subjects who are regularly consuming soy meat, soy protein, soy protein-containing food/drink/supplement, soy milk and/or soybean flour for more than 3 times a week, and unable to discontinue from the time consent is obtained (2) Subjects who are regularly consuming foods for specified health uses, foods with function claims, supplement, health foods and/or lactic acid bacteria-fermented food, which would affect the study for more than 3 times a week, and unable to maintain the amount and frequency of consumption during the study (3) Subjects who are regularly taking medicines which would affect the study (e.g. antibiotics, laxatives) at least once a week and unable to restricted during the study (No oral administration, but ophthalmic and nasal drip are acceptable) (4) Subjects with a current history of serious illnesses related to immunity, such as autoimmune diseases, or gastrointestinal diseases (5) Subjects who are pregnant, lactating, or intending to become pregnant during the study period (6) Subjects who are allergic to soybean foods (7) Subjects who take excessive alcohol (8) Subjects who are now under other clinical study with some kind of medicine/food, or participated in those within a month before this study, or will join those after giving informed consent to participate in this study (9) Others who have been determined ineligible by the principal/sub investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gut metabolites | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Gut microbiota (16S rRNA amplicon) 2) Defecation status (frequency, quantity, property, color, feeling of incomplete evacuation, abdominal pain, odor of defecation) | — |
Countries
Japan
Contacts
Public ContactKazuteru Fukuhara
SHOKUNOCHIKARA CORP. Headquarters
Outcome results
None listed