Epicatechin-enriched Dark Chocolate for Improved Mitochondrial Function in Heart Failure and Diabetes Patients
This study aims to evaluate how consuming dark chocolate enriched with Epicatechin can improve exercise capacity and skeletal muscle metabolism, as well as alter specific biomarker levels in the blood, skeletal muscle, and urine of patients with heart failure and diabetes.
Epicatechin-enriched dark chocolate
+ Low-epicatechin dark chocolate
+ Epicatechin-enriched dark chocolate
Cardiovascular Diseases+6
+ Diabetes Mellitus
+ Endocrine System Diseases
Summary
Study start date: July 1, 2012
Actual date on which the first participant was enrolled.The flavanol epicatechin (which is derived from cocoa and has no known toxicity in humans) has been shown in clinical trials to increase levels of nitric oxide (NO) as assessed by flow-mediated dilation (FMD) in the brachial artery and measurements of circulating NO in plasma. NO is thought to be an activator of PGC-1 alpha [PPAR (peroxisome proliferator-activated receptor) alpha coactivator 1] which stimulates mitochondrial biogenesis. In both patients with heart failure and diabetes there is nitric oxide deficiency and mitochondrial dysfunction. In our proposed double-blinded placebo controlled clinical trial, we will test the hypothesis that chronic administration of epicatechin to patients with both heart failure and diabetes will increase levels of NO and PGC-1 alpha leading to increased mitochondrial biogenesis and improved mitochondrial function. We believe similar changes will occur in sedentary individuals. In a preliminary study with 5 patients with heart failure and diabetes (conducted under UCSD IRB protocol number #090688) we have shown that epicatechin enriched dark chocolate improves mitochondrial structure (Taub PR, Ramirez-Sanchez I, Ciaraldi TP, et al. 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. 2011;5(1):43-47.)
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.21 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 40 to 70 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Healthy, sedentary individuals: Inclusion Criteria: Healthy, inactive individuals BMI 27-32 Exclusion Criteria: Smoking or quit smoking less than 1 year prior to enrollment Currently taking Coumadin or Pradaxa. Heart failure and diabetes patients: Inclusion Criteria: Medically diagnosed with heart failure and diabetes No significant HbA1C fluctuations in past 6 months Exclusion Criteria: Currently taking Insulin Currently taking Coumadin or Pradaxa. Smoking or quit smoking less than 1 year prior to enrollment
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
University of California, San Diego
La Jolla, United StatesOpen University of California, San Diego in Google Maps