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

June 1, 2015 updated by: Pam Taub, MD, University of California, San Diego

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.)

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sedentary
The sedentary arm will be randomly assigned to either epicatechin-enriched dark chocolate or low-epicatechin dark chocolate as a placebo. Participants will take one square of chocolate per day for 90 days.
Dietary supplement: Epicatechin-enriched dark chocolate
For experimental purposes, subjects will take one square of epicatechin-enriched dark chocolate per day for 90 days.
Other: Low-epicatechin dark chocolate
As a placebo control, subjects will take 1 square of low-epicatechin chocolate per day for 90 days.
Experimental: Heart failure/diabetes
The heart failure/diabetes arm will be randomly assigned to either epicatechin-enriched dark chocolate or low-epicatechin dark chocolate as a placebo. Participants will take one square of chocolate per day for 90 days.
Dietary supplement: Epicatechin-enriched dark chocolate
For experimental purposes, subjects will take one square of epicatechin-enriched dark chocolate per day for 90 days.
Other: Low-epicatechin dark chocolate
As a placebo control, subjects will take 1 square of low-epicatechin chocolate per day for 90 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in exercise capacity
Time Frame: Baseline and 3 months
Objectively evaluate exercise capacity through cycle ergometry to measure VO2 max.
Baseline and 3 months
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
Baseline and 3 months
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.
Baseline and 3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Collaborators

The Hershey Company

Investigators

  • Principal Investigator: Pam Taub, MD, Assistant Professor of Medicine, University of California, San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

August 20, 2012

First Submitted That Met QC Criteria

August 22, 2012

First Posted (Estimate)

August 23, 2012

Study Record Updates

Last Update Posted (Estimate)

June 3, 2015

Last Update Submitted That Met QC Criteria

June 1, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCSD IRB 111680

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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