Back to resultsEffects of Epicatechin on Functional Capacity, Skeletal Muscle Structure and Diastolic Function in Patients With Heart Failure With Preserved Ejection Fraction (HFPEF) (HFPEF)
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CocoaVia
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring with preserved ejection fraction of >55%
Eligibility Criteria
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
Sites / Locations
- University of California, San Diego
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CocoaVia capsules
Arm Description
From baseline to 3 months, patients will consume 2 capsules containing pure epicatechin
Outcomes
Primary Outcome Measures
Change from baseline in exercise capacity
Objectively evaluate exercise capacity through cycle ergometry to measure VO2 max
Change from baseline in skeletal muscle metabolism
The change in skeletal muscle metabolism will be evaluated by magnetic resonance spectroscopy
Change from baseline in pre-specified biomarker levels in blood, skeletal muscle, and urine
Skeletal muscle biopsies and blood draws will be performed to obtain experimental samples
Secondary Outcome Measures
Full Information
NCT ID
NCT02068040
First Posted
February 18, 2014
Last Updated
June 1, 2015
Sponsor
University of California, San Diego
1. Study Identification
Unique Protocol Identification Number
NCT02068040
Brief Title
Effects of Epicatechin on Functional Capacity, Skeletal Muscle Structure and Diastolic Function in Patients With Heart Failure With Preserved Ejection Fraction (HFPEF)
Acronym
HFPEF
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
4. Oversight
5. Study Description
Brief Summary
The major goal of this proposal is to characterize the ability of epicatechin which a component of dark chocolate to improve the
structural and functional features of skeletal muscle (SkM)
exercise capacity (as assessed by VO2 max)
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.
Detailed Description
Patient Inclusion/Exclusion Criteria:
New York Heart Association Class II/III HF with preserved ejection fraction (EF) of >50%.
Nonsmokers
Subject not taking Coumadin, Xarelto, Prasugrel or Pradaxa. Patients on Plavix for drug eluting stent will not be excluded.
Ages between 40-65. We will exclude any women of child bearing potential
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
with preserved ejection fraction of >55%
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CocoaVia capsules
Arm Type
Experimental
Arm Description
From baseline to 3 months, patients will consume 2 capsules containing pure epicatechin
Intervention Type
Dietary Supplement
Intervention Name(s)
CocoaVia
Other Intervention Name(s)
Epicatechin consumption
Intervention Description
CocoaVia contains flavanols found natrually in cocoa beans. Capsules will contain 250mg of flavanol
Primary Outcome Measure Information:
Title
Change from baseline in exercise capacity
Description
Objectively evaluate exercise capacity through cycle ergometry to measure VO2 max
Time Frame
Baseline and 3 months
Title
Change from baseline in skeletal muscle metabolism
Description
The change in skeletal muscle metabolism will be evaluated by magnetic resonance spectroscopy
Time Frame
Baseline and 3 months
Title
Change from baseline in pre-specified biomarker levels in blood, skeletal muscle, and urine
Description
Skeletal muscle biopsies and blood draws will be performed to obtain experimental samples
Time Frame
Baseline and 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of California, San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22376256
Citation
Taub PR, Ramirez-Sanchez I, Ciaraldi TP, Perkins G, Murphy AN, Naviaux R, Hogan M, Maisel AS, Henry RR, Ceballos G, Villarreal F. Alterations in skeletal muscle indicators of mitochondrial structure and biogenesis in patients with type 2 diabetes and heart failure: effects of epicatechin rich cocoa. Clin Transl Sci. 2012 Feb;5(1):43-7. doi: 10.1111/j.1752-8062.2011.00357.x. Epub 2011 Nov 7.
Results Reference
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Effects of Epicatechin on Functional Capacity, Skeletal Muscle Structure and Diastolic Function in Patients With Heart Failure With Preserved Ejection Fraction (HFPEF)
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