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

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