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Completed

NCT Number: NCT02490527

Effects of Epicatechin on Statins for Mitochondrial Dysfunction and Impaired Exercise Capacity

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.

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Key information

Conditions

Statin Intolerance Fatigue Muscle Weakness Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Spasm

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Diego

La Jolla, California, 92093, United States

About this study

Patient Inclusion Criteria:

  • Must be between 30-75 years of age.
  • Must have a VO2max greater than 18 ml/kg/min(non-sedentary individuals).
  • Subjects with LDL>100mg/dL (or on drug treatment)
  • Subjects without a prior cerebrovascular event (example: stroke)
  • Subjects without a prior cardiovascular event (example: heart attack)

Patient Exclusion Criteria:

  • Liver, thyroid, or kidney disease.
  • Currently taking drugs that interfere with statin metabolism (calcium channel blockers, colchicine etc.).
  • Acute or chronic infectious disease; autoimmune/inflammatory disease, cancer, COPD, anemia, diabetes, psychiatric illness.
  • Non-smokers, prior smokers, or illicit drug users with abstinence >1 year.
  • Subjects taking blood thinners (Coumadin, xarelto, pradaxa, Plavix, effient, apixiban, 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.
  • 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:

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Patient Inclusion Criteria:

  • Must be between 30-75 years of age
  • LDL>100mg/dL (or on drug treatment)
  • 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

Treatment and study plan

Pure epicatechin capsules (50mg)

Dietary Supplement

Epicatechin is a compound found naturally in dark chocolate.

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.

Primary outcomes

  1. Changes in Functional Capacity

    Time frame: Baseline and 3 months

    Cardiopulmonary exercise protocol will be used to measure VO2max to assess functional capacity.

Other outcomes

  1. Changes in Blood-Based Biomarkers

    Time frame: Baseline and 3 months

    Biomarker levels in the blood will be evaluated for correlation with changes in the skeletal muscle mitochondrial structure and function.

  2. Composite Outcome: Changes in Skeletal Muscle Structure and Protein Levels

    Time frame: Baseline and 3 months

    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.

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • American Heart Association

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Jul 7, 2015
Registry last updated
Sep 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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