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

University of California San Diego

Status: Completed

Conditions: Type 2 Diabetes; Heart Failure

Treatments: Dietary Supplement: Epicatechin-enriched dark chocolate; Other: Low-epicatechin dark chocolate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01671514

UCSD IRB 111680

Details and patient eligibility

About

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.

Full 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.)

Enrollment: 21 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

21 participants in 2 patient groups

Sedentary

Experimental group

Description:

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.

Treatment:

Other: Low-epicatechin dark chocolate

Dietary Supplement: Epicatechin-enriched dark chocolate

Heart failure/diabetes

Experimental group

Description:

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.

Treatment:

Other: Low-epicatechin dark chocolate

Dietary Supplement: Epicatechin-enriched dark chocolate