Effects of Epicatechin on Statins for Mitochondrial Dysfunction and Impaired Exercise Capacity
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 30 - 75 |
| Updated: | 4/17/2018 |
| Start Date: | June 2015 |
| End Date: | June 2019 |
| Contact: | Hannah Lo, B.S. |
| Email: | ucsdresearchcoordinator@gmail.com |
| Phone: | 858-246-2510 |
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.
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:
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
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
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
We found this trial at
1
site
9500 Gilman Dr
La Jolla, California 92093
La Jolla, California 92093
(858) 534-2230
Principal Investigator: Pam Taub, MD
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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