Effects of Epicatechin on Patients With Statin-induced Mitochondrial Dysfunction and Impaired Exercise Capacity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Changes in Functional Capacity
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Statin only
The subject will consume simvastatin (40mg) and placebo once daily for 3 months.
干预措施: Placebo (Other)
Statin and epicatechin
The subject will consume simvastatin (40mg) and pure epicatechin capsules (50mg) once daily for 3 months.
干预措施: Pure epicatechin capsules (50mg) (Dietary Supplement)
Statin only
The subject will consume simvastatin (40mg) and placebo once daily for 3 months.
干预措施: Simvastatin (40mg) (Drug)
Statin and epicatechin
The subject will consume simvastatin (40mg) and pure epicatechin capsules (50mg) once daily for 3 months.
干预措施: Simvastatin (40mg) (Drug)
结局指标
主要结局
Changes in Functional Capacity
时间窗: Baseline and 3 months
Cardiopulmonary exercise protocol will be used to measure VO2max to assess functional capacity.
Changes in Functional Capacity (VO2max)
时间窗: Baseline and 3 months
Cardiopulmonary exercise protocol will be used to measure VO2max to assess functional capacity.
次要结局
- Changes in Blood-Based Biomarkers(Baseline and 3 months)
- Changes in Blood-Based Biomarkers-Low Density Lipoprotein Particles(Baseline and 3 months)
- Changes in Triglycerides/HDL(Baseline and 3 months)
研究者
Pam Taub, MD
Associate Professor of Medicine
University of California, San Diego
