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

This study is ongoing, but not recruiting participants.
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: February 18, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Heart Failure
Type 2 Diabetes
Dietary Supplement: Epicatechin-enriched dark chocolate
Other: Low-epicatechin dark chocolate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official 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

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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


Estimated Enrollment: 60
Study Start Date: July 2012
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.)

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01671514

Locations
United States, California
University of California, San Diego
La Jolla, California, United States, 92093
Sponsors and Collaborators
University of California, San Diego
The Hershey Company
Investigators
Principal Investigator: Pam Taub, MD Assistant Professor of Medicine, University of California, San Diego
  More Information

Publications:
Responsible Party: Pam Taub, MD, Assistant Professor of Medicine, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01671514     History of Changes
Other Study ID Numbers: UCSD IRB 111680
Study First Received: August 20, 2012
Last Updated: February 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
mitochondrial biogenesis
skeletal muscle
epicatechin

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Heart Failure
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014