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

This study is currently recruiting participants.
Verified September 2012 by University of California, San Diego
Sponsor:
Collaborator:
The Hershey Company
Information provided by (Responsible Party):
Pam Taub, MD, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01671514
First received: August 20, 2012
Last updated: September 5, 2012
Last verified: September 2012
History of Changes

August 20, 2012
September 5, 2012
July 2012
July 2016   (final data collection date for primary outcome measure)
  • Change from baseline in exercise capacity [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]
    Objectively evaluate exercise capacity through cycle ergometry to measure VO2 max.
  • Change from baseline in skeletal muscle metabolism [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]
    The change in skeletal muscle metabolism will be evaluated by magnetic resonance spectroscopy
  • Change from baseline in pre-specified biomarker levels in blood, skeletal muscle, and urine [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]
    Skeletal muscle biopsies and blood draws will be performed to obtain experimental samples.
Same as current
Complete list of historical versions of study NCT01671514 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Change from baseline in quality of life, health, and nutrition questionnaires [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]
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
Same as current
 
Effects of Dark Chocolate on Exercise Capacity, and Mitochondrial Structure and Function
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.

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.)
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
  • Heart Failure
  • Type 2 Diabetes
  • 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: 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.
    Interventions:
    • Dietary Supplement: Epicatechin-enriched dark chocolate
    • Other: Low-epicatechin dark chocolate
  • 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.
    Interventions:
    • Dietary Supplement: Epicatechin-enriched dark chocolate
    • Other: Low-epicatechin dark chocolate
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
July 2017
July 2016   (final data collection date for primary outcome measure)

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
Both
40 Years to 70 Years
Yes
Contact: Pam Taub, MD 858-657-5354 chocolatestudy2@gmail.com
United States
 
NCT01671514
UCSD IRB 111680
Yes
Pam Taub, MD, University of California, San Diego
University of California, San Diego
The Hershey Company
Principal Investigator: Pam Taub, MD Assistant Professor of Medicine, University of California, San Diego
University of California, San Diego
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP