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.

Study Overview

• Status: Terminated
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Other: Medical Food Formulation 1; Other: Medical Food Formulation 2; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Cork, Ireland
    • Atlantia Food Clinical Trials, 1st Floor, Block C, Heron House, Blackpool Retail Park

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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
Fasting Lipid Panel	Change in fasting serum concentrations of total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides	From Baseline to Week 12
Adverse Events	Number of participants with adverse events related to therapy	From Baseline to Week 12
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
Body weight	Change in body weight in kilograms	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

Collaborators and Investigators

• Sponsor: Pendulum Therapeutics
• Investigators: Study Director: Orville Kolterman, MD, Whole Biome

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 6, 2019
• Primary Completion (ACTUAL): April 15, 2020
• Study Completion (ACTUAL): May 30, 2020

Study Registration Dates

• First Submitted: July 26, 2019
• First Submitted That Met QC Criteria: August 5, 2019
• First Posted (ACTUAL): August 6, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 6, 2022
• Last Update Submitted That Met QC Criteria: May 2, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: AFCRO-104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No