NCT02656212

Early Phase Pre-Clinical and Initial Clinical Research on Epicatechin (Part 2)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Veterans Medical Research Foundation · Academic / Other
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Pre-diabetes

Interventions

Type	Name	Description
DRUG	epicatechin	30 mg (+)-epicatechin, taken orally, one pill/day in the morning
DRUG	Placebo	Placebo pill, taken orally, one pill/day in the morning

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2016-01-14
• Last updated: 2016-04-28

Locations

2 sites across 1 country: United States