Open-Label Study of the Influence of Agaricus brasiliensis KA21 on the oral and intestinal microbiome
- Conditions
- Healthy male/female adults
- Registration Number
- JPRN-UMIN000049121
- Lead Sponsor
- Toei Shinyaku Co.,Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Not provided
1)Subjects who are regularly consuming food or supplement containing beta-glucan which is the active ingredient of test food. 2)Subjects under treatment which would affects the trial results. 3) Subjects who do not carry out the inspection including collecting saliva and stool samples under the test rule. 4) Subjects with chronic diarrhea symptoms. 5) Subjects who have current medical history/anamnesis of severe diabetes, hepatic, renal, hypertension, cardiac, hepatic, glucose tolerance diseases. 6)Subjects who would be allergic to test foods. 7)Subjects who want to pregnancy, pregnant, possibly pregnant, or lactating women. 8)Subjects who are participating or have been participated to other clinical tests with specific medicine/food within the last 4 weeks before this trial, or planning to join those after giving informed consent. 9)Subjects who take excessive alcohol or subjects with irregular dietary habits. 10)Subjects who have a plan or who have taken antibiotics within 3 months prior to the trial. 11)Subjects who have a plan or who have taken medication which would affect the trial result (e.g. drugs for intestinal disorder, and laxative) within 2 weeks prior to the trial. 12)Subjects who have removed tonsils and/or appendix. 13)Subjects who have received the surgery which would affect the trial result (e.g. colonoscopy, removal of gallstones and/or gall bladder, or gastric bypass surgery) within half a year before obtaining the consent. 14)Subjects who would encounter a dramatic change in their living environment (e.g. relocation, job-changing). 15)Others who have been determined ineligible by principal investigator or cooperating institution.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Intestinal microbiome
- Secondary Outcome Measures
Name Time Method 1.Oral microbiome 2.Defecation status 3.Body weight, BMI, Waist size 4.SF36v2 Japanese version