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

Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01671514
• Other study ID #: UCSD IRB 111680
• Status: Completed
• Phase: N/A
• First received: August 20, 2012
• Last updated: June 1, 2015
• Start date: July 2012
• Est. completion date: December 2014

Study information

• Verified date: June 2015
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

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.)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Heart Failure
• Type 2 Diabetes

Intervention

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.

Locations

Country	Name	City	State
United States	University of California, San Diego	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	The Hershey Company

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline in quality of life, health, and nutrition questionnaires	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	No
Primary	Change from baseline in exercise capacity	Objectively evaluate exercise capacity through cycle ergometry to measure VO2 max.	Baseline and 3 months	No
Primary	Change from baseline in skeletal muscle metabolism	The change in skeletal muscle metabolism will be evaluated by magnetic resonance spectroscopy	Baseline and 3 months	No
Primary	Change from baseline in pre-specified biomarker levels in blood, skeletal muscle, and urine	Skeletal muscle biopsies and blood draws will be performed to obtain experimental samples.	Baseline and 3 months	No