Effects of Epicatechin on Functional Capacity, Skeletal Muscle Structure and Diastolic Function in Patients With Heart Failure With Preserved Ejection Fraction (HFPEF) (HFPEF)

June 1, 2015 updated by: Pam Taub, MD, University of California, San Diego

The major goal of this proposal is to characterize the ability of epicatechin which a component of dark chocolate to improve the

  1. structural and functional features of skeletal muscle (SkM)
  2. exercise capacity (as assessed by VO2 max)
  3. parameters of diastolic heart function (as assessed by echocardiography)

We propose that a 3 month treatment with epicatechin (through CocoaVia® capsules) will lead to a significant improvement in exercise capacity and diastolic function.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patient Inclusion/Exclusion Criteria:

  1. New York Heart Association Class II/III HF with preserved ejection fraction (EF) of >50%.
  2. Nonsmokers
  3. Subject not taking Coumadin, Xarelto, Prasugrel or Pradaxa. Patients on Plavix for drug eluting stent will not be excluded.
  4. Ages between 40-65. We will exclude any women of child bearing potential

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92093
        • University of California, San Diego

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Medically Diagnosed Heart Failure with Ejection Fraction of >55%
  • BMI 27-32
  • No Significant HbA1C fluctuations in past 6 months

Exclusion Criteria:

  • Smoking or quit smoking less than 1 year prior to enrollment
  • Substance Abuse
  • Taking Coudmadin or Pradaxa

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CocoaVia capsules
From baseline to 3 months, patients will consume 2 capsules containing pure epicatechin
Dietary supplement: CocoaVia
CocoaVia contains flavanols found natrually in cocoa beans. Capsules will contain 250mg of flavanol
Other Names:
  • Epicatechin consumption

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in skeletal muscle metabolism
Time Frame: Baseline and 3 months
The change in skeletal muscle metabolism will be evaluated by magnetic resonance spectroscopy
Baseline and 3 months
Change from baseline in exercise capacity
Time Frame: Baseline and 3 months
Objectively evaluate exercise capacity through cycle ergometry to measure VO2 max
Baseline and 3 months
Change from baseline in pre-specified biomarker levels in blood, skeletal muscle, and urine
Time Frame: Baseline and 3 months
Skeletal muscle biopsies and blood draws will be performed to obtain experimental samples
Baseline and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

February 18, 2014

First Submitted That Met QC Criteria

February 19, 2014

First Posted (Estimate)

February 20, 2014

Study Record Updates

Last Update Posted (Estimate)

June 3, 2015

Last Update Submitted That Met QC Criteria

June 1, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCSD IRB 130398

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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