Outcomes
The primary study outcomes are total circulating and fecal BAs, taurine-conjugated BAs, and DCA. Secondary outcomes include body weight, body composition, dietary change (i.e., MedDiet adherence), physical activity (i.e., steps per day), metabolic risk, circulating cytokines (e.g., IL-6, TNFα), gut microbial community structure and composition, fecal short chain fatty acids (SCFAs) (i.e., butyrate, acetate, propionate), and exfoliated intestinal cell gene expression levels. Data collection will take place at UIC and by telephone at baseline, month 3, and study end. All data collection staff will be trained and certified in informed consent, testing procedures, specimen processing, and data management. All procedures will be written and stored electronically. Major changes to study design will first be reviewed and approved by the IRB before implementation. The primary data collectors and lab technicians will be blinded to randomization group assignment by having the assignment hidden from view in their individual REDCap account.