Placebo-Controlled Clinical Nutrition Study of the Safety and Metabolic Effects of Two Medical Foods in Type 2 Diabetes

Inclusion Criteria: * Type 2 diabetes treated with diet and exercise alone or in combination with metformin and/or sulfonylurea * If treated with metformin and/or sulfonylurea, must have been on a stable dose of the drug(s) for a minimum of 3 months with a stable A1c value * If treated with diet and exercise alone, must have one of the following: * Documented fasting plasma glucose \>126 mg/dL * A1c value ≥6.8% * If treated with diet and exercise + metformin and/or sulfonylurea, must have a stable A1c between 6.8% and 11.0% for 3 months prior study entry * BMI \>25 but \<45 and weight stable within +/- 5% over past 3 months * If female, must meet all the following criteria: * Not pregnant or breastfeeding * If of childbearing potential (including peri-menopausal women with menstruation during past year) must practice and be willing to continue appropriate birth control during the entire duration of the study * Have a home freezer available for immediate freezing of stool samples * Able to read, understand, and sign the informed consent form (ICF) and HIPAA authorization when applicable, * Able to communicate with the investigator, and understand and comply with protocol requirements Exclusion Criteria: * Use of antibiotic, antifungal, antiparasitic, or antiviral therapy within 30 days prior to study entry * Planned use or antibiotic, antifungal, antiparasitic, or antiviral treatment during the study period * Subjects using a proton pump inhibitor must be on a stable dose that will be maintained throughout the study period * Present use of probiotics/nutritional supplements. (Note: Use of replacement doses of Vitamin D, calcium supplements, and a single daily multi-vitamin tablet allowed) * Participation in a structured weight-loss program within the past 2 months * Change in body weight ≥5% within the past month * Excess alcohol consumption; with an alcoholic drink defined as 12 fluid ounces of beer (5% alcohol), 5 fluid ounces of wine (12% alcohol) or 1.5 fluid ounces of 80 proof distilled spirits * Women: More than 2 alcoholic drinks/day or more than 7 drinks/week * Men: More than 3 alcoholic drinks/day or more than 10 drinks/week * Travel outside United States within 30 days of study entry * Planned travel outside United States during study period * Use of an experimental drug within 30 days prior to study entry * Known milk, peanut, tree nut, wheat, soy or shellfish allergy * Diagnosis of a sexually transmitted disease including, but not limited to, HIV, syphilis, herpes, gonorrhea, hepatitis A, hepatitis B, and hepatitis C * Hospitalization during last 3 months (Same day surgery center procedures allowed) * Active GI disease * Gastrointestinal tract surgery (appendectomy and cholecystectomy allowed) * Cystic fibrosis * Any condition deemed by the investigator to disqualify subject