Placebo-Controlled Clinical Nutrition Study of the Metabolic Effects of Food Product WBF-0011 in Type 2 Diabetes

The medical food formulations being tested in this study contain butyrate‐producing organisms plus a microbial strain that contributes to the integrity of the colonic mucin barrier. The microbes have been fully characterized, certified as Generally Recognized As Safe (GRAS) and manufactured to Good Manufacturing Practice (GMP) standards using excipients that are also GRAS qualified. Subjects will receive their randomized formulation twice a day for 12 weeks.The target population will be patients with Type 2 Diabetes who are not treated with anti‐diabetic agents or are treated with metformin alone.