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



Status:Recruiting
Conditions:Cardiology, Diabetes
Therapuetic Areas:Cardiology / Vascular Diseases, Endocrinology
Healthy:No
Age Range:40 - 70
Updated:3/1/2014
Start Date:July 2012
End Date:July 2017
Contact:Pam Taub, MD
Email:chocolatestudy2@gmail.com
Phone:858-657-5354

Use our guide to learn which trials are right for you!

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.)

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
We found this trial at
1
site
9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
?
mi
from
La Jolla, CA
Click here to add this to my saved trials