Abnormal Glucose Tolerance Clinical Trial
Official title:
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.
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.
;
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