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| Name | Class |
|---|---|
| American Heart Association | OTHER |
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The purpose of this study is to gain insight into the side-effects of statin consumption, and assess the ability of epicatechin (a compound in dark chocolate) to counteract or reverse these changes. The investigators' prior research has shown that epicatechin can improve skeletal muscle structure and mitochondrial (which gives us energy) structure.
Patient Inclusion Criteria:
Patient Exclusion Criteria:
The study will be a double blind placebo controlled study where subjects will be randomized to either of two groups:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Statin only | Placebo Comparator | The subject will consume simvastatin (40mg) and placebo once daily for 3 months. |
|
| Statin and epicatechin | Experimental | The subject will consume simvastatin (40mg) and pure epicatechin capsules (50mg) once daily for 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pure epicatechin capsules (50mg) | Dietary Supplement | Epicatechin is a compound found naturally in dark chocolate. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Functional Capacity | Cardiopulmonary exercise protocol will be used to measure VO2max to assess functional capacity. | Baseline and 3 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in Blood-Based Biomarkers | Biomarker levels in the blood will be evaluated for correlation with changes in the skeletal muscle mitochondrial structure and function. | Baseline and 3 months |
| Composite Outcome: Changes in Skeletal Muscle Structure and Protein Levels |
Patient Inclusion Criteria:
Patient Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pam Taub, M.D. | 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. | |
| 20579545 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 25, 2024 | |
| Reset | Jul 15, 2024 | |
| Release | Aug 2, 2024 | |
| Reset | Aug 28, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 25, 2024 | Jul 15, 2024 | |||
| Aug 2, 2024 |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D018908 | Muscle Weakness |
| D013035 | Spasm |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D020879 | Neuromuscular Manifestations |
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| ID | Term |
|---|---|
| D019821 | Simvastatin |
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Simvastatin (40mg) | Drug | A cholesterol-lowering medication that blocks the production of cholesterol. |
|
| Placebo | Other | A substance that has no therapeutic effect and will act as a control. |
|
The optional skeletal muscle biopsies will be examined by electron microscopy to determine change in skeletal muscle structure. Western blots will be done to look for changes in protein levels. |
| Baseline and 3 months |
| Background |
| Yamazaki KG, Taub PR, Barraza-Hidalgo M, Rivas MM, Zambon AC, Ceballos G, Villarreal FJ. Effects of (-)-epicatechin on myocardial infarct size and left ventricular remodeling after permanent coronary occlusion. J Am Coll Cardiol. 2010 Jun 22;55(25):2869-76. doi: 10.1016/j.jacc.2010.01.055. |
| 21788351 | Background | Nogueira L, Ramirez-Sanchez I, Perkins GA, Murphy A, Taub PR, Ceballos G, Villarreal FJ, Hogan MC, Malek MH. (-)-Epicatechin enhances fatigue resistance and oxidative capacity in mouse muscle. J Physiol. 2011 Sep 15;589(Pt 18):4615-31. doi: 10.1113/jphysiol.2011.209924. Epub 2011 Jul 25. |
| 22833114 | Background | Ramirez-Sanchez I, Nogueira L, Moreno A, Murphy A, Taub P, Perkins G, Ceballos GM, Hogan M, Malek M, Villarreal F. Stimulatory effects of the flavanol (-)-epicatechin on cardiac angiogenesis: additive effects with exercise. J Cardiovasc Pharmacol. 2012 Nov;60(5):429-38. doi: 10.1097/FJC.0b013e318269ae0d. |
| 23870648 | Background | Ramirez-Sanchez I, Taub PR, Ciaraldi TP, Nogueira L, Coe T, Perkins G, Hogan M, Maisel AS, Henry RR, Ceballos G, Villarreal F. (-)-Epicatechin rich cocoa mediated modulation of oxidative stress regulators in skeletal muscle of heart failure and type 2 diabetes patients. Int J Cardiol. 2013 Oct 9;168(4):3982-3990. doi: 10.1016/j.ijcard.2013.06.089. Epub 2013 Jul 17. |
| 23642227 | Background | Taub PR, Ramirez-Sanchez I, Ciaraldi TP, Gonzalez-Basurto S, Coral-Vazquez R, Perkins G, Hogan M, Maisel AS, Henry RR, Ceballos G, Villarreal F. Perturbations in skeletal muscle sarcomere structure in patients with heart failure and type 2 diabetes: restorative effects of (-)-epicatechin-rich cocoa. Clin Sci (Lond). 2013 Oct;125(8):383-9. doi: 10.1042/CS20130023. |
| 25598082 | Background | Barnett CF, Moreno-Ulloa A, Shiva S, Ramirez-Sanchez I, Taub PR, Su Y, Ceballos G, Dugar S, Schreiner G, Villarreal F. Pharmacokinetic, partial pharmacodynamic and initial safety analysis of (-)-epicatechin in healthy volunteers. Food Funct. 2015 Mar;6(3):824-33. doi: 10.1039/c4fo00596a. |
| 25281837 | Background | Ortiz-Vilchis P, Yamazaki KG, Rubio-Gayosso I, Ramirez-Sanchez I, Calzada C, Romero-Perez D, Ortiz A, Meaney E, Taub P, Villarreal F, Ceballos G. Co-administration of the flavanol (-)-epicatechin with doxycycline synergistically reduces infarct size in a model of ischemia reperfusion injury by inhibition of mitochondrial swelling. Eur J Pharmacol. 2014 Dec 5;744:76-82. doi: 10.1016/j.ejphar.2014.09.042. Epub 2014 Oct 2. |
| 24314870 | Background | Gutierrez-Salmean G, Ciaraldi TP, Nogueira L, Barboza J, Taub PR, Hogan MC, Henry RR, Meaney E, Villarreal F, Ceballos G, Ramirez-Sanchez I. Effects of (-)-epicatechin on molecular modulators of skeletal muscle growth and differentiation. J Nutr Biochem. 2014 Jan;25(1):91-4. doi: 10.1016/j.jnutbio.2013.09.007. Epub 2013 Oct 18. |
| 40387782 | Derived | Ormiston CK, Pazargadi A, Rosander A, Ceballos G, Villarreal F, Taub PR. Enhancement of Statin Effects on Lipid Lowering and Reduction of Cardiovascular Risk Score by (-)-Epicatechin in Proof-of-Concept Pilot Study. Clin Transl Sci. 2025 May;18(5):e70236. doi: 10.1111/cts.70236. |
| Aug 28, 2024 |
| Jul 7, 2026 |
| D009461 | Neurologic Manifestations |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |