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

Evaluation of the Safety and Effects on Glycemic Control of Medical Food Formulation WBF-0031 in Subjects With Abnormal Glucose Tolerance

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

Study Overview

• Status: Unknown
• Conditions: Abnormal Glucose Tolerance
• Intervention / Treatment: Dietary supplement: WBF-0031

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Bend, Oregon, United States, 97703
      • Diabetes and Obesity Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Assessment of Adverse Events	Safety assessed via spontaneous adverse events reported during the study period and changes in chemistry 14 panel	30 weeks
Time spent in target blood glucose	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.	Three 14 day intervals

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Glucose Area Under the Curve (AUC) from baseline	Twelve and 24 week difference from baseline in total Glucose AUC during a standard Meal Tolerance Test (MMT)	24 weeks
Incremental Glucose Area Under the Curve (AUC) from baseline	Twelve and 24 week difference from baseline in incremental Glucose AUC during a standard Meal Tolerance Test (MMT)	24 weeks
Glucose peaks	Mean and standard deviation of post-prandial peak glucose and time to peak for each meal	30 weeks
A1c	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.	Week 0, Week 12, Week 24

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Questionnaire	Quality of life questionnaire responses measured at 0, 12 and 24 weeks.	Week 0, Week 12, Week 24

Collaborators and Investigators

• Sponsor: Eden Miller
• Collaborators: Pendulum Therapeutics
• Investigators: Principal Investigator: Eden Miller, D.O., Diabetes and Obesity Care

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2020
• Primary Completion (ANTICIPATED): February 1, 2021
• Study Completion (ANTICIPATED): February 28, 2021

Study Registration Dates

• First Submitted: July 13, 2020
• First Submitted That Met QC Criteria: July 27, 2020
• First Posted (ACTUAL): July 29, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 29, 2020
• Last Update Submitted That Met QC Criteria: July 27, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia; Glucose Intolerance
• Other Study ID Numbers: WB01-501

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