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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02330276
Recruitment Status : Completed
First Posted : January 1, 2015
Results First Posted : April 17, 2017
Last Update Posted : April 17, 2017
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
San Diego Veterans Healthcare System
University of California, San Diego
Information provided by (Responsible Party):
Robert R. Henry, MD, Veterans Medical Research Foundation

Tracking Information
First Submitted Date  ICMJE December 23, 2014
First Posted Date  ICMJE January 1, 2015
Results First Submitted Date  ICMJE January 8, 2016
Results First Posted Date  ICMJE April 17, 2017
Last Update Posted Date April 17, 2017
Study Start Date  ICMJE September 2014
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 3, 2017)
Change From Baseline in Circulating Urinary Concentrations of Intact Epicatechin and Epi Metabolites [ Time Frame: Baseline and 24 hours ]
This will be initial PK study on synthetic (+)-epicatechin in humans. Circulating and urinary concentrations of intact epicatechin and epicatechin metabolites, including specific enantiomers
Original Primary Outcome Measures  ICMJE
 (submitted: December 30, 2014)
Levels of Epicatechin and Metabolites [ Time Frame: 24 hours ]
Levels of epicatechin and metabolites present in circulation and urine.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2017)
  • Change From Baseline in Major Safety Endpoints [ Time Frame: Baseline and 24 hours ]
    Clinically significant differences in the major safety endpoints are defined as: BP (10 mm Hg change), HR (10 bpm), creatinine (>1.5 ULN), and highly conservative changes in alkaline phosphatase and liver transaminases (>1.5 ULN).
  • Change From Baseline in Circulating Glucose Concentrations (mg/dL*24hr) [ Time Frame: Baseline and 24 hours ]
  • Change From Baseline in Circulating Insulin Concentrations (uU/mL*24hr) [ Time Frame: Baseline and 24 hours ]
  • Change From Baseline in Circulating C-Peptide Concentrations (ng/mL*24hr) [ Time Frame: Baseline and 24 hours ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 30, 2014)
Adverse Events [ Time Frame: 9 Days ]
Number of Participants with Adverse Events as a Measure of Safety and Tolerability.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Early Phase Pre-Clinical and Initial Clinical Research on Epicatechin
Official Title  ICMJE (+)-Epicatechin: Early Phase Pre-Clinical and Initial Clinical Research on Epicatechin
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pre-diabetes
Intervention  ICMJE 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.
Other Name: Epicatechin
Study Arms  ICMJE
  • Experimental: 10 mg (+)-epicatechin
    4 subjects randomized to one dose of 10 mg (+)-epicatechin taken orally
    Intervention: Drug: (+)-Epicatechin
  • Experimental: 30 mg (+)-epicatechin
    4 subjects randomized to one dose of 30 mg (+)-epicatechin taken orally
    Intervention: Drug: (+)-Epicatechin
  • Experimental: 100 mg (+)-epicatechin
    4 subjects randomized to one dose of 100 mg (+)-epicatechin taken orally
    Intervention: Drug: (+)-Epicatechin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 30, 2014)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02330276
Other Study ID Numbers  ICMJE 08847
1R01AT008310-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Robert R. Henry, MD, Veterans Medical Research Foundation
Study Sponsor  ICMJE Veterans Medical Research Foundation
Collaborators  ICMJE
  • National Institutes of Health (NIH)
  • National Center for Complementary and Integrative Health (NCCIH)
  • San Diego Veterans Healthcare System
  • University of California, San Diego
Investigators  ICMJE
Principal Investigator: Robert R Henry, MD San Diego Veterans Healthcare System
PRS Account Veterans Medical Research Foundation
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP