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临床试验/NCT02490527
NCT02490527已完成不适用

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

University of California, San Diego1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2015年6月1日最近更新:
适应症
干预措施
相关药物

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:

  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:

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

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

Placebo Comparator

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

干预措施: Placebo (Other)

Statin and epicatechin

Experimental

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

Placebo Comparator

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

干预措施: Simvastatin (40mg) (Drug)

Statin and epicatechin

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pam Taub, MD

Associate Professor of Medicine

University of California, San Diego

研究点 (1)

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