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

NCT ID: NCT04490460

Last Updated: 2020-07-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2021-02-28

Brief Summary

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

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.

Conditions

Abnormal Glucose Tolerance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: PLACEBO_COMPARATOR

WBF-0031

Intervention Type: DIETARY_SUPPLEMENT

Medical food formulation WBF-0031

Second 12 Weeks

1 capsule administered twice daily with morning and evening meal for 12 weeks. All participants receiving WB-0031.

Group Type: ACTIVE_COMPARATOR

WBF-0031

Intervention Type: DIETARY_SUPPLEMENT

Medical food formulation WBF-0031

Interventions

WBF-0031

Medical food formulation WBF-0031

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pendulum Therapeutics

INDUSTRY

Sponsor Role: collaborator

Eden Miller

INDUSTRY

Sponsor Role: lead

Responsible Party

Eden Miller

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Eden Miller, D.O.

Role: PRINCIPAL_INVESTIGATOR

Diabetes and Obesity Care

Locations

Diabetes and Obesity Care

Bend, Oregon, United States

Countries

United States

Other Identifiers

WB01-501

Identifier Type: -

Identifier Source: org_study_id