Effects on Glycemic Control of WBF-0031 in Subjects With Abnormal Glucose Tolerance

• ClinicalTrials.gov Identifier: NCT04490460
• Recruitment Status: Unknown
• First Posted: July 29, 2020
• Last Update Posted: July 29, 2020
• Sponsor: Eden Miller
• Collaborator: Pendulum Therapeutics
• Information provided by (Responsible Party): Eden Miller, Diabetes and Obesity Care

Study Description

Brief Summary:

Evaluation of the safety and effects on glycemic control of medical food formulation WBF-0031 in subjects with abnormal glucose control.

Condition or disease	Intervention/treatment	Phase
Abnormal Glucose Tolerance	Dietary Supplement: WBF-0031	Not Applicable

Detailed Description:

The current study aims to investigate if altering the microbiome though Pendulum Glucose Control supplementation can have implications aimed at maintaining normal blood glucose levels that are critical for preventing diabetes and its metabolic complications. The experimental design consists of two-12 week treatment periods in subjects with prediabetes, as defined by the National Diabetes Prevention Program (DPP) criteria.

The first study period of 12 weeks will be double-blinded, placebo-controlled. The Pendulum Glucose control and placebo will be in a capsule form and identical in appearance, and dispensed to each participant according to the randomization schedule in the first 12 weeks. All subjects will receive the active product (Pendulum Glucose Control) in the second, subsequent 12 week period.

Fasting total cholesterol, triglycerides, LDL, and HDL cholesterol, Fasting insulin and Glucose, High sensitivity C Reactive Protein (hsCRP), Chemistry 14, and HbA1c will be obtained at baseline, and during first and second study period, as well as vital signs of weight, BP, and waist circumference.

In addition, CGM (Abbott System Freestyle Libre Pro) data collection will be done three times during the study as noted in Schedule of Events. Baseline Blinded CGM will be performed for approximately 14 days prior to starting the intervention with Pendulum Glucose Control. Second Blinded CGM period for approximately 14 days will occur mid-way through the intervention (weeks 5 and 6) and a third period of Blinded CGM wear will occur during the last 2 weeks of the intervention (weeks 11 and 12). During the Baseline, study period one and period 2 a mixed meal tolerance consisting of 2 Boost Shakes will be given on day 5 of each sensor wear.

At the completion of the study, analysis of the vital signs, laboratory values, CGM data for average glucose, standard deviation, TIR (time in range), as well as glycemic results of MMT for each time interval; baseline, study period one, and two.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Balanced randomization first arm, formulation WBF-0031 and placebo. Second arm all subjects formulation WBF-0031.
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Study product was provided for each arm in identical capsules.
• Primary Purpose: Treatment
• Official Title: Evaluation of the Safety and Effects on Glycemic Control of Medical Food Formulation WBF-0031 in Subjects With Abnormal Glucose Tolerance
• Actual Study Start Date: June 1, 2020
• Estimated Primary Completion Date: February 1, 2021
• Estimated Study Completion Date: February 28, 2021

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: First 12 Weeks; 1 capsule administered twice daily with morning and evening meal for 12 weeks. Double blind 50% Placebo capsules identical to those containing WB-0031 and 50% WB-0031	Dietary Supplement: WBF-0031; Medical food formulation WBF-0031
Active Comparator: Second 12 Weeks; 1 capsule administered twice daily with morning and evening meal for 12 weeks. All participants receiving WB-0031.	Dietary Supplement: WBF-0031; Medical food formulation WBF-0031

Outcome Measures

Primary Outcome Measures :

1. Safety Assessment of Adverse Events [ Time Frame: 30 weeks ]
   Safety assessed via spontaneous adverse events reported during the study period and changes in chemistry 14 panel
2. Time spent in target blood glucose [ Time Frame: Three 14 day intervals ]
   Difference in daily glucose levels as measured by the amount of time spent in target blood glucose for each CGM wear period. Adjustable glucose thresholds will be set as follows:<60 mg/dL, <70 mg/dL, >140 mg/dL, >180 mg/dL and >240 mg/dL. The percent of values above, below, and between these points will be calculated.

Secondary Outcome Measures :

1. Total Glucose Area Under the Curve (AUC) from baseline [ Time Frame: 24 weeks ]
   Twelve and 24 week difference from baseline in total Glucose AUC during a standard Meal Tolerance Test (MMT)
2. Incremental Glucose Area Under the Curve (AUC) from baseline [ Time Frame: 24 weeks ]
   Twelve and 24 week difference from baseline in incremental Glucose AUC during a standard Meal Tolerance Test (MMT)
3. Glucose peaks [ Time Frame: 30 weeks ]
   Mean and standard deviation of post-prandial peak glucose and time to peak for each meal
4. A1c [ Time Frame: Week 0, Week 12, Week 24 ]
   Improvement in A1c measured as a change in A1c levels from baseline at 12 and 24 weeks. Subjects enrolled in the study will have fasting A1c measurements at the time of enrollment and weeks, 0, 12 and 24 weeks.

Other Outcome Measures:

1. Questionnaire [ Time Frame: Week 0, Week 12, Week 24 ]
   Quality of life questionnaire responses measured at 0, 12 and 24 weeks.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Between 18-80 years of age
2. BMI < 45 kg/m2

3. Eligible based on a recent (within the past year) blood test meeting one of these specifications:

   1. Fasting glucose of 100 to 125 mg/dl
   2. Plasma glucose measured 2 hours after a 75-gram glucose load of 140 to 199 mg/dl
   3. A1c of 5.7 to 6.4%
   4. Clinically diagnosed gestational diabetes mellitus (GDM) during a previous pregnancy (may be self-reported)
4. Willing to comply with study requirements
5. Provide written informed consent

Exclusion Criteria:

1. Known diagnosis of diabetes / taking any medication for the treatment of diabetes including the off-label use of a GLP-1 receptor agonist, SGLT-2, or metformin) within the last 3 months for weight loss.
2. Active participation in another lifestyle or behavior change education or research program (DPP or weight loss program)
3. Current treatment with systemic corticosteroids (topical and nasal steroids are allowed)
4. Subjects who have received an antibiotic, antifungal, antiparasitic, or antiviral treatment within 30 days prior to study entry
5. Pregnant women

Contacts and Locations

Locations

United States, Oregon

Diabetes and Obesity Care

Bend, Oregon, United States, 97703

Sponsors and Collaborators

Eden Miller

Pendulum Therapeutics

Investigators

• Principal Investigator: Eden Miller, D.O.; Diabetes and Obesity Care

More Information

• Responsible Party: Eden Miller, Principal Investigator, Diabetes and Obesity Care
• ClinicalTrials.gov Identifier: NCT04490460
• Other Study ID Numbers: WB01-501
• First Posted: July 29, 2020
• Last Update Posted: July 29, 2020
• Last Verified: July 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Glucose Intolerance; Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases