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

University of California San Diego

Status: Completed

Conditions: Statin Intolerance

Treatments: Dietary Supplement: Pure epicatechin capsules (50mg); Other: Placebo; Drug: Simvastatin (40mg)

Study type: Interventional

Funder types: Other

Identifiers

NCT02490527

UCSD IRB 150171

Details and patient eligibility

About

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.

Full 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

Enrollment: 19 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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19 participants in 2 patient groups, including a placebo group

Statin only

Placebo Comparator group

Description:

The subject will consume simvastatin (40mg) and placebo once daily for 3 months.

Treatment:

Other: Placebo

Drug: Simvastatin (40mg)

Statin and epicatechin

Experimental group

Description:

The subject will consume simvastatin (40mg) and pure epicatechin capsules (50mg) once daily for 3 months.

Treatment:

Dietary Supplement: Pure epicatechin capsules (50mg)

Drug: Simvastatin (40mg)