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

September 27, 2021 updated by: Pam Taub, MD, University of California, San Diego

Effects of Epicatechin on Patients With Statin-induced 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patient Inclusion Criteria:

  1. Must be between 30-75 years of age.
  2. Must have a VO2max greater than 18 ml/kg/min(non-sedentary individuals).
  3. Subjects with LDL>100mg/dL (or on drug treatment)
  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, 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.
  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

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Statin only
The subject will consume simvastatin (40mg) and placebo once daily for 3 months.
Drug: Simvastatin (40mg)
A cholesterol-lowering medication that blocks the production of cholesterol.
Other: Placebo
A substance that has no therapeutic effect and will act as a control.
Experimental: Statin and epicatechin
The subject will consume simvastatin (40mg) and pure epicatechin capsules (50mg) once daily for 3 months.
Drug: Simvastatin (40mg)
A cholesterol-lowering medication that blocks the production of cholesterol.
Dietary supplement: Pure epicatechin capsules (50mg)
Epicatechin is a compound found naturally in dark chocolate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Functional Capacity
Time Frame: Baseline and 3 months
Cardiopulmonary exercise protocol will be used to measure VO2max to assess functional capacity.
Baseline and 3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 3 months
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.
Baseline and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Collaborators

American Heart Association

Investigators

  • Principal Investigator: Pam Taub, M.D., University of California, San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

July 28, 2021

Study Completion (Actual)

July 28, 2021

Study Registration Dates

First Submitted

June 17, 2015

First Submitted That Met QC Criteria

July 1, 2015

First Posted (Estimate)

July 7, 2015

Study Record Updates

Last Update Posted (Actual)

September 29, 2021

Last Update Submitted That Met QC Criteria

September 27, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCSD IRB 150171

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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