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

An Placebo-Controlled Clinical Nutrition Study to Evaluate the Metabolic Effects of Two Medical Food Products in Subjects With Type 2 Diabetes Treated With Diet and Exercise Alone or in Combination With Metformin ± Sulfonylurea

This 16 week placebo-controlled study evaluates the safety and impact of two medical food study products, WBF10 and WBF11, consisting of commensal microbes. The primary endpoints were safety, glucose AUC during meal tolerance test and C reactive protein (CRP)..

Targeting the microbiome for treating metabolic syndrome has been gaining traction with multiple population studies demonstrating a difference between healthy individuals and patients with metabolic syndrome. Whole Biome has identified and created two medical food formulations (MFFs) aimed at improving metabolic syndrome via two mechanisms of action targeting the microbiome: (1) increasing butyrate production and (2) increasing mucin regulation.

This randomized, parallel-group, placebo-controlled, double-blinded study assesses the safety and metabolic effects of 2 MFFs on glucose control and the generalized inflammatory state associated with Type 2 Diabetes. The microbes have been fully characterized, certified as Generally Recognized As Safe (GRAS) and manufactured to Good Manufacturing Practice (GMP) standards. The target population was patients with Type 2 Diabetes who either had not been treated with antidiabetic agents or treated with metformin +/- a sulfonylurea. Subjects were randomized in a balanced manner to receive capsules containing placebo, WBF10 or WBF11.

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