Trial Purpose and Description
We will establish the ability of a fermented soy liquid to modify the oral and colonic microbiome while reducing systemic inflammation in lean and obese individuals. We will also assay the activation of the inflammasome machinery in peripheral blood cells in the two populations.
Ages: 18 - 70 years
Adults (aged between 18 and 70) that are obese (BMI 32-37) (n=10)
Adults (aged between 18 and 70) that are lean (BMI 21-25) (n=10)
- Allergy to soy or soy derivatives.
- Patients will be excluded if they had abdominal surgeries (excluding cholecystectomy, appendectomy, hysterectomy, and hernia repair).
- History of inflammatory bowel disease (e.g., ulcerative colitis, Crohn’s disease) and/or gastrointestinal bleeding.
- Medications: Antibiotics, probiotics, or systemic corticosteroids (within 6 months of enrollment). Radiation proctitis or other known poorly controlled medical conditions that could interfere with bowel function.
- Patients will be excluded if using medications, which are known to be affected by modest dietary changes. This will include, but is not limited to, warfarin and immunosuppressives such as cyclosporin.
- Alcohol use disorder (or alcohol consumption greater than 40g, approx. 3 drinks, per day), anorexia nervosa, autoimmune disease, bulimia, celiac disease, chronic infections, and illicit drug use.
- Major changes in dietary habits in past six months.
- Pregnancy or intent to get pregnant during study period
BESO Biological Research, Inc.
Dates: 12/18/2015 - 12/31/2016
Last Updated: 03/02/2016
Study HIC#: 1507016139