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Early Phase Pre-Clinical and Initial Clinical Research on Epicatechin

NCT02330276 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2017-04-17

Study results available
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Summary

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

Conditions

  • Pre-diabetes

Interventions

DRUG

(+)-Epicatechin

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.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Center for Complementary and Integrative Health (NCCIH)

    collaborator NIH

  • San Diego Veterans Healthcare System

    collaborator FED

  • University of California, San Diego

    collaborator OTHER

  • Veterans Medical Research Foundation

    lead OTHER

Principal Investigators

  • Robert R Henry, MD · San Diego Veterans Healthcare System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02330276 on ClinicalTrials.gov