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NCT Number: NCT01671514

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

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

1. Patients with heart failure (HF) and type 2 diabetes (DM2) and 2. 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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Key information

Conditions

Heart Failure Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Metabolic Diseases Nutritional and Metabolic Diseases Type 2 Diabetes

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Diego

La Jolla, California, 92093, United States

About this study

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.)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Epicatechin-enriched dark chocolate

Dietary Supplement

For experimental purposes, subjects will take one square of epicatechin-enriched dark chocolate per day for 90 days.

Low-epicatechin dark chocolate

Other

As a placebo control, subjects will take 1 square of low-epicatechin chocolate per day for 90 days.

Primary outcomes

  1. Change from baseline in exercise capacity

    Time frame: Baseline and 3 months

    Objectively evaluate exercise capacity through cycle ergometry to measure VO2 max.

  2. 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

  3. 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.

Other outcomes

  1. Change from baseline in quality of life, health, and nutrition questionnaires

    Time frame: Baseline and 3 months

    Specific questionnaires utilized include SF-36 questionnaire, Morisky Medication Adherence Scale (MMAS-8) questionnaire, the Minnesota Living with Heart Failure scale (MLHFQ), the Physical Activity Enjoyment Scale (PACES), the Leisure Time Exercise questionnaire (LTE), the Multidimensional Fatigue Symptom Inventory (MFSI) and the Block Questionnaires for Dietary Fat Screening and Fruit/Vegetable/Fiber Screening

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • The Hershey Company

Registry information

Official study title

Effects of Epicatechin-enriched Dark Chocolate on Mitochondrial Function and Exercise Capacity in Patients With Both Diabetes and Heart Failure and in Sedentary Individuals

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Aug 23, 2012
Registry last updated
Jun 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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