NCT04490460

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Eden Miller · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	WBF-0031	Medical food formulation WBF-0031

Timeline

• Start date: 2020-06-01
• Primary completion: 2021-02-01
• Completion: 2021-02-28
• First posted: 2020-07-29
• Last updated: 2020-07-29

Locations

1 site across 1 country: United States