This will be a double-blind, randomized, placebo-controlled, single dose study of (+)- epicatechin with one 30mg dose/day for a total of 7 days
This project is a double-blinded, placebo-controlled, randomized, Phase I study that will include (+)-epicatechin dosing over seven days. * Subjects will meet the American Diabetes Association (ADA) criteria for pre-diabetes, including impaired fasting glucose (IFG) \[refer to inclusion/exclusion criteria\]. * The Project includes: 7 day evaluation of a single daily dose of synthetic (+)-epicatechin in pre-diabetic individuals as compared to placebo. * The Project has 4 outpatient clinic study visits: screening (Visit 1), randomization (Visit 2), end of study drug (Visit 3), follow up end of study (Visit 4). * This Project has 2 telephone visits Primary hypothesis: As these studies are designed to evaluate safety and tolerability, there is no primary hypothesis to test. Primary outcome measures. Vital signs and safety labs: BP, HR, creatinine, alkaline phosphatase, and liver transaminases These studies will provide initial data about if (+)-epicatechin can influence glycemic control in individuals with prediabetes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
15
30 mg (+)-epicatechin, taken orally, one pill/day in the morning
Placebo pill, taken orally, one pill/day in the morning
CMR Center for Metabolic Research VASDHS
San Diego, California, United States
VA San Diego Healthcare System
San Diego, California, United States
Change from baseline in major safety endpoints: Blood Pressure (BP)
Clinically significant differences in the major safety endpoints are defined as: BP (10 mm Hg change)
Time frame: Baseline and Day 7
Change from baseline in major safety endpoints: Heart Rate (HR)
Clinically significant differences in the major safety endpoints are defined as: HR (10 bpm)
Time frame: Baseline and Day 7
Change from baseline in major safety endpoints: Kidney Function
Clinically significant differences in the major safety endpoints are defined as: creatinine (\>1.5 ULN)
Time frame: Baseline and Day 7
Change from baseline in major safety endpoints: Hepatic Function
Clinically significant differences in the major safety endpoints are defined as: highly conservative changes in alkaline phosphatase and liver transaminases (\>1.5 ULN)
Time frame: Baseline and Day 7
Change from baseline: Glucose
Change from baseline of glucose (mg/dL) as measured from fasting labs collected at Visits 2 and 3.
Time frame: Baseline and Day 7
Change from baseline: Insulin
Change from baseline of insulin (uIU/ml) as measured from fasting labs collected at Visits 2 and 3.
Time frame: Baseline and Day 7
Change from baseline: C-Peptide
Change from baseline of C-Peptide (ng/mL) as measured from fasting labs collected at Visits 2 and 3.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Baseline and Day 7