Summary

for people ages 30-75 (full criteria)
healthy people welcome
at UCSD
study started
estimated completion:
Pam Taub (ucsd)

Description

Summary

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.

Official Title

Effects of Epicatechin on Patients With Statin-induced Mitochondrial Dysfunction and Impaired Exercise Capacity

Details

Patient Inclusion Criteria:

  1. Must be between 30-75 years of age.
  2. Must have a VO2max greater than 25 ml/kg/min(non-sedentary individuals).
  3. Subjects with LDL>100mg/dL
  4. Subjects without a prior cerebrovascular event (example: stroke)
  5. Subjects without a prior cardiovascular event (example: heart attack)

Patient Exclusion Criteria:

  1. Liver, thyroid, or kidney disease.
  2. Currently taking drugs that interfere with statin metabolism (calcium channel blockers, colchicine etc.).
  3. Acute or chronic infectious disease; autoimmune/inflammatory disease, cancer, COPD, anemia, diabetes, psychiatric illness.
  4. Non-smokers, prior smokers, or illicit drug users with abstinence >1 year.
  5. Subjects taking blood thinners (Coumadin, xarelto, pradaxa, Plavix, effient, epixiban etc) will be excluded. If subjects are taking aspirin for routine prevention they will be asked to hold aspirin for 7 days prior to biopsy. Routine prevention means that the patients are taking aspirin to reduce their risks, but do not have established cardiovascular disease.
  6. History of previous knee surgery and active history of knee pain or neuromuscular disease are exclusions as they are known to affect muscle structure and function.

The study will be a double blind placebo controlled study where subjects will be randomized to either of two groups:

  1. Simvastatin 40 mg + placebo once daily (statin only group) for 3 months
  2. Simvastatin 40 mg + Epi 50 mg once daily (statin + Epi group) for 3 months

Keywords

Statin Intolerance myopathy muscular weakness cramping fatigue Simvastatin Hydroxymethylglutaryl-CoA Reductase Inhibitors Pure epicatechin capsules (50mg) Simvastatin (40mg) Statin only Statin and epicatechin

Eligibility

For people ages 30-75

Patient Inclusion Criteria:

  • Must be between 30-75 years of age
  • LDL>100mg/dL
  • VO2 max greater than 25 ml/kg/min

Patient Exclusion Criteria:

  • Liver or kidney disease
  • Currently taking drugs that interfere with statin metabolism
  • Currently taking blood thinners
  • Acute or chronic infectious disease; autoimmune/inflammatory disease, cancer, COPD,anemia, psychiatric illness, insulin-dependent diabetes
  • smokers or illicit drug users
  • adverse cardiovascular event (ex: heart attack)
  • history of knee surgery or active history of knee pain

Location

  • University of California, San Diego accepting new patients
    La Jolla California 92093 United States

Lead Scientist

  • Pam Taub (ucsd)
    Dr. Taub is a general cardiologist and assistant professor of medicine at the UC San Diego Health System. She is the director of the Hannah and Gene Step Cardiac Wellness and Rehabilitation Center that will be located in the new UC San Diego Jacobs Medical Center opening in 2016. The mission of the Center is to actively engage patients and the community in prevention of cardiovascular disease.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT02490527
Study Type
Interventional
Last Updated