Placebo-Controlled Clinical Nutrition Study of the Metabolic Effects of Food Product WBF-0011 in Type 2 Diabetes
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Other: PlaceboOther: Medical Food Formulation 1Other: Medical Food Formulation 2
- Registration Number
- NCT04047537
- Lead Sponsor
- Pendulum Therapeutics
- Brief Summary
This 12 week placebo-controlled study evaluates the safety and impact of 2 different strengths of the medical food formulation WBF-0011.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 41
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Be able to give written informed consent
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Have type 2 diabetes treated with diet and exercise alone or in combination with metformin
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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
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If treated with diet and exercise alone, must have A1c value ≥6.5%
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If treated with diet and exercise + metformin, must have a stable A1c between 7.0% and 8.5% for at least 3 months
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BMI >25 but <45
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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
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Must be able to communicate with the investigator, and understand and comply with protocol requirements
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Subjects who have received an antibiotic, antifungal, antiparasitic, or antiviral treatment within 30 days prior to study entry
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Subjects who plan to use antibiotic, antifungal, antiparasitic, or antiviral treatment during the study
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Subjects using a proton pump inhibitor must be on a consistent dose that will be maintained throughout the study period
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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)
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Subjects who have participated in a structured weight-loss program within the past 3 months
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Subjects who have changed body weight ≥3% within the past month
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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
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Subjects who have received an experimental drug within 30 days prior to study entry
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Hospitalization for any reason within the 3 months prior to study entry (Same day surgery centre visits/procedures allowed)
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Active GI disease
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History of any surgery on the gastrointestinal tract except appendectomy and cholecystectomy
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Cystic fibrosis
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Significant renal Impairment defined as estimated Glomerular Filtration Rate <45 ml/min
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Subjects receiving systemic corticosteroid therapy
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Subjects receiving Immunosuppression therapy
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Subjects with any condition that the investigator deems as a sound reason for disqualification from enrollment into the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo 2 capsules/day (one in the morning and one in the evening), taken with meal for 12 weeks Experimental: WBF-0011 Medical Food Formulation 1 2 capsules/day (one in the morning and one in the evening), taken with meal for 12 weeks Experimental: WBF-0011 (0.2X concentration) Medical Food Formulation 2 2 capsules/day (one in the morning and one in the evening), taken with meal for 12 weeks
- Primary Outcome Measures
Name Time Method Hemoglobin A1c From Baseline to Week 12 Change from baseline to Week 12 in each of the treatment groups as compared to placebo in A1c levels
- Secondary Outcome Measures
Name Time Method 24-hour CGM From Baseline to Week 12 Time in range (70 to 180 mg/dL)/24-hour period
3-hour blood glucose AUC Baseline to Weeks 1, 3, 4, 5, 7, 8, 10, and 11. as measured by the CGM device at home during standardized 3-hour Meal Tolerance Test (MTT)
3-hour blood glucose Area Under the Curve (AUC) Baseline to Weeks 2, 6, 9 and 12 as measured by the Continuous Glucose Monitor (CGM) device in clinic during standardized 3-hour Meal Tolerance Test (MTT)
3-hour plasma glucose AUC Baseline to Weeks 2, 6, 9 and 12 as measured by laboratory plasma glucose measurements during standardized 3-hour Meal Tolerance Test (MTT)
Fasting Lipid Panel From Baseline to Week 12 Change in fasting serum concentrations of total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides
Body weight From Baseline to Week 12 Change in body weight in kilograms
Adverse Events From Baseline to Week 12 Number of participants with adverse events related to therapy
Change from baseline in Laboratory Chemistry Values From Baseline to Week 12 Number of Participants With Abnormal Laboratory Values Related to Therapy
Change from baseline in Laboratory Complete Blood count Values From Baseline to Week 12 Number of Participants With Abnormal Laboratory Values Related to Therapy
Trial Locations
- Locations (1)
Atlantia Food Clinical Trials, 1st Floor, Block C, Heron House, Blackpool Retail Park
🇮🇪Cork, Ireland