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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Other: Medical Food Formulation 1
* Other: Medical Food Formulation 2
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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: Not pregnant or breastfeeding 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 Women: More than 11 standard drinks/week 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Experimental: WBF-0011<br>2 capsules/day (one in the morning and one in the evening), taken with meal for 12 weeks | Other: Medical Food Formulation 1<br>* WBF-0011<br>|
| Other: Experimental: WBF-0011 (0.2X concentration)<br>2 capsules/day (one in the morning and one in the evening), taken with meal for 12 weeks | Other: Medical Food Formulation 2<br>* WBF-0011 (0.2X concentration)<br>|
| Other: Placebo<br>2 capsules/day (one in the morning and one in the evening), taken with meal for 12 weeks | Other: Placebo<br>* Placebo Capsules identical to those containing Formulation 1 and 2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1c | Change from baseline to Week 12 in each of the treatment groups as compared to placebo in A1c levels | From Baseline to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-hour blood glucose Area Under the Curve (AUC) | as measured by the Continuous Glucose Monitor (CGM) device in clinic during standardized 3-hour Meal Tolerance Test (MTT) | Baseline to Weeks 2, 6, 9 and 12 | 
| 3-hour plasma glucose AUC | as measured by laboratory plasma glucose measurements during standardized 3-hour Meal Tolerance Test (MTT) | Baseline to Weeks 2, 6, 9 and 12 | 
| 3-hour blood glucose AUC | as measured by the CGM device at home during standardized 3-hour Meal Tolerance Test (MTT) | Baseline to Weeks 1, 3, 4, 5, 7, 8, 10, and 11. | 
| 24-hour CGM | Time in range (70 to 180 mg/dL)/24-hour period | From Baseline to Week 12 | 
| Fasting Lipid Panel | Change in fasting serum concentrations of total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides | From Baseline to Week 12 | 
| Body weight | Change in body weight in kilograms | From Baseline to Week 12 | 
| Adverse Events | Number of participants with adverse events related to therapy | From Baseline to Week 12 | 
| Change from baseline in Laboratory Chemistry Values | Number of Participants With Abnormal Laboratory Values Related to Therapy | From Baseline to Week 12 | 
| Change from baseline in Laboratory Complete Blood count Values | Number of Participants With Abnormal Laboratory Values Related to Therapy | From Baseline to Week 12 |