Heart Failure Clinical Trial

Effects of Dark Chocolate on Exercise Capacity, and Mitochondrial Structure and Function

Summary

The major goal of this study is to characterize the ability of dark chocolate enriched in epicatechin (a component of dark chocolate) to improve the structural and functional features of mitochondria in two groups

Patients with heart failure (HF) and type 2 diabetes (DM2) and
Normal yet sedentary individuals with impaired baseline exercise capacity (as assessed by VO2 max)

We propose that a 3 month treatment with dark chocolate will lead to a significant improvement in exercise capacity which will be secondary to the improvement in skeletal muscle structure from epicatechin.

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Full Description

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.)

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Eligibility 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 is for people with:

Heart Failure

Estimated Enrollment:

21

Study ID:

NCT01671514

Recruitment Status:

Completed

Sponsor:

University of California, San Diego

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There is 1 Location for this study

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

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Study is for people with:

Heart Failure

Estimated Enrollment:

21

Study ID:

NCT01671514

Recruitment Status:

Completed

Sponsor:


University of California, San Diego

How clear is this clinincal trial information?

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