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

NCT ID: NCT01671514

Last Updated: 2015-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2014-12-31

Brief 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.

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.)

Conditions

Heart Failure; Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Epicatechin-enriched dark chocolate

Intervention Type: DIETARY_SUPPLEMENT

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

Low-epicatechin dark chocolate

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

Epicatechin-enriched dark chocolate

Intervention Type: DIETARY_SUPPLEMENT

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

Low-epicatechin dark chocolate

Intervention Type: OTHER

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

Interventions

Epicatechin-enriched dark chocolate

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

Intervention Type: DIETARY_SUPPLEMENT

Low-epicatechin dark chocolate

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Healthy, inactive individuals
• BMI 27-32

• Medically diagnosed with heart failure and diabetes
• No significant HbA1C fluctuations in past 6 months

Exclusion Criteria

• Smoking or quit smoking less than 1 year prior to enrollment
• Currently taking Coumadin or Pradaxa.

Heart failure and diabetes patients:

• Currently taking Insulin
• Currently taking Coumadin or Pradaxa.
• Smoking or quit smoking less than 1 year prior to enrollment

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Hershey Company

INDUSTRY

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Pam Taub, MD

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pam Taub, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor of Medicine, University of California, San Diego

Locations

University of California, San Diego

La Jolla, California, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 22376256 (View on PubMed)

Other Identifiers

UCSD IRB 111680

Identifier Type: -

Identifier Source: org_study_id