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

A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety and Metabolic Effects of Two Formulations of a Food Product (WBF-0011) When Administered to Subjects With Type 2 Diabetes Treated With Diet and Exercise Alone or in Combination With Metformin

This 12 week placebo-controlled study evaluates the safety and impact of 2 different strengths of the medical food formulation WBF-0011.

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.

Inclusion Criteria:

• Be able to give written informed consent

• Have type 2 diabetes treated with diet and exercise alone or in combination with metformin

• If treated with metformin, must have been on a stable dose of the drug for a minimum of 3 months with a stable A1c value

• If treated with diet and exercise alone, must have A1c value ≥6.5%

• If treated with diet and exercise + metformin, must have a stable A1c between 7.0% and 8.5% for at least 3 months

• BMI >25 but <45

• If female, must meet all the following criteria:

  1. Not pregnant or breastfeeding
  2. If of childbearing potential (including peri-menopausal women who have had a menstrual period within one year) must practice and be willing to continue to practice appropriate birth control during the entire duration of the study

• Must be able to communicate with the investigator, and understand and comply with protocol requirements

Exclusion Criteria:

• Subjects who have received an antibiotic, antifungal, antiparasitic, or antiviral treatment within 30 days prior to study entry

• Subjects who plan to use antibiotic, antifungal, antiparasitic, or antiviral treatment during the study

• Subjects using a proton pump inhibitor must be on a consistent dose that will be maintained throughout the study period

• Present use of probiotics/nutritional supplements. (Note: The use of replacement doses of Vitamin D, calcium supplements, and a single daily multi-vitamin tablet is allowed)

• Subjects who have participated in a structured weight-loss program within the past 3 months

• Subjects who have changed body weight ≥3% within the past month

• Excess alcohol consumption; with an alcoholic drink defined as 284 ml of beer, lager, stout , 100 ml of wine or 35.5 ml spirits

  1. Women: More than 11 standard drinks/week
  2. Men: More than 17 standard drinks/week

• Subjects who have received an experimental drug within 30 days prior to study entry

• Hospitalization for any reason within the 3 months prior to study entry (Same day surgery centre visits/procedures allowed)

• Active GI disease

• History of any surgery on the gastrointestinal tract except appendectomy and cholecystectomy

• Cystic fibrosis

• Significant renal Impairment defined as estimated Glomerular Filtration Rate <45 ml/min

• Subjects receiving systemic corticosteroid therapy

• Subjects receiving Immunosuppression therapy

• Subjects with any condition that the investigator deems as a sound reason for disqualification from enrollment into the study