Conditions: Pre-diabetes
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 12
Healthy volunteers: yes

Brief summary:
Early Phase Pre-Clinical and Initial Clinical Research on (+)- Epicatechin.

Detailed description:
This project is a double-blinded randomized Phase I study that will include dose-ranging one day PK and pharmacodynamic (PD) studies. Subjects will include healthy individuals and subjects who meet the American Diabetes Association (ADA) criteria for pre-diabetes, including IFG.

Arms:
arm 1: 4 subjects randomized to one dose of 10 mg (+)-epicatechin taken orally arm 2: 4 subjects randomized to one dose of 30 mg (+)-epicatechin taken orally arm 3: 4 subjects randomized to one dose of 100 mg (+)-epicatechin taken orally

Interventions: intervention 1: (+)-Epicatechin
Intervention descriptions: intervention 1: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included.

Protocol document: