Assessing the Role of a Fermented Soy Extract in Inflammation and the Human Microbiome in Obese Adults

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

Gender: Both


Eligibility Criteria

Inclusion Criteria:

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)


Exclusion Criteria:

  • 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

Get Involved

For more information about this study, contact:
Maxine Fields
203-785-5691
maxine.fields@yale.edu

If you would prefer to contact a member of the Help us Discover team about this trial and other similar trials, please email helpusdiscover@yale.edu or call 1-877-978-8348.

Trial Image

Investigators

Ather Ali

Principal Investigator

Sub-Investigators