Overview

Early Phase Pre-Clinical and Initial Clinical Research on Epicatechin

Status:
Completed
Trial end date:
2015-08-01
Target enrollment:
0
Participant gender:
All
Summary
Early Phase Pre-Clinical and Initial Clinical Research on (+)- Epicatechin.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Veterans Medical Research Foundation
Collaborators:
National Center for Complementary and Integrative Health (NCCIH)
National Institutes of Health (NIH)
San Diego Veterans Healthcare System
University of California, San Diego
Criteria
Inclusion Criteria:

- Healthy or pre-diabetic based on medical history

- Male or female

- Must be 21 to 75 years of age (inclusive)

- Able to give informed consent to the procedures

- If female, must be either postmenopausal or test negative for pregnancy at screening
and on the day of the procedure. Women on estrogen therapy will be included.

- If of childbearing potential, must practice and be willing to continue to practice
appropriate birth control during the entire duration of the study

- Medication use stable for 4 weeks

- Body Mass Index (BMI) > 27 kg/m^2

- Definition of pre-diabetes: impaired fasting glucose (IFG, fasting glucose = 100-125
mg/dL) and elevated HbA1c (5.7-6.4%), each in the absence of other risk factors for
diabetes

Exclusion Criteria:

- Type 2 diabetes

- Pregnancy

- Younger than 21 or older than 75 years of age

- Clinically significant abnormalities in liver or kidney function (>3x ULN), determined
in the last 6 months by a certified clinical laboratory

- Recent MI or stroke (within 6 months of screening)

- Blood pressure (BP) >160 mmHg Systolic and >100 mmHg Diastolic

- Medications - thiazolidinediones, any steroids, anti-depressants, weight loss drugs

- Other diseases, besides type 2 diabetes, influencing carbohydrate metabolism