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| Name | Class |
|---|---|
| The Hershey Company | INDUSTRY |
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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
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.)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sedentary | Experimental | 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. |
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| Heart failure/diabetes | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epicatechin-enriched dark chocolate | Dietary Supplement | For experimental purposes, subjects will take one square of epicatechin-enriched dark chocolate per day for 90 days. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in exercise capacity | Objectively evaluate exercise capacity through cycle ergometry to measure VO2 max. | Baseline and 3 months |
| Change from baseline in skeletal muscle metabolism | The change in skeletal muscle metabolism will be evaluated by magnetic resonance spectroscopy | Baseline and 3 months |
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Healthy, sedentary individuals:
Inclusion Criteria:
Exclusion Criteria:
Heart failure and diabetes patients:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pam Taub, MD | Assistant Professor of Medicine, University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego | La Jolla | California | 92093 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22376256 | Background | 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. |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
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| Low-epicatechin dark chocolate | Other | As a placebo control, subjects will take 1 square of low-epicatechin chocolate per day for 90 days. |
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| Baseline and 3 months |
| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |