Effects of Epicatechin on Functional Capacity, Skeletal Muscle Structure and Diastolic Function in Patients With Heart Failure With Preserved Ejection Fraction (HFPEF)
HFPEF
1 other identifier
interventional
7
1 country
1
Brief Summary
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable heart-failure
Started Jan 2014
Shorter than P25 for not_applicable heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 18, 2014
CompletedFirst Posted
Study publicly available on registry
February 20, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedJune 3, 2015
June 1, 2015
1.2 years
February 18, 2014
June 1, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change from baseline in exercise capacity
Objectively evaluate exercise capacity through cycle ergometry to measure VO2 max
Baseline and 3 months
Change from baseline in skeletal muscle metabolism
The change in skeletal muscle metabolism will be evaluated by magnetic resonance spectroscopy
Baseline and 3 months
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
Baseline and 3 months
Study Arms (1)
CocoaVia capsules
EXPERIMENTALFrom baseline to 3 months, patients will consume 2 capsules containing pure epicatechin
Interventions
CocoaVia contains flavanols found natrually in cocoa beans. Capsules will contain 250mg of flavanol
Eligibility Criteria
You may qualify if:
- Medically Diagnosed Heart Failure with Ejection Fraction of \>55%
- BMI 27-32
- No Significant HbA1C fluctuations in past 6 months
You may not qualify if:
- Smoking or quit smoking less than 1 year prior to enrollment
- Substance Abuse
- Taking Coudmadin or Pradaxa
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California, San Diego
La Jolla, California, 92093, United States
Related Publications (1)
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.
PMID: 22376256BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. Pam Taub
Study Record Dates
First Submitted
February 18, 2014
First Posted
February 20, 2014
Study Start
January 1, 2014
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
June 3, 2015
Record last verified: 2015-06