Effects of Epicatechin-enriched Dark Chocolate on Mitochondrial Function and Exercise Capacity in Patients With Both Diabetes and Heart Failure and in Sedentary Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Change from baseline in pre-specified biomarker levels in blood, skeletal muscle, and urine
研究概览
简要总结
The major goal of this study is to characterize the ability of dark chocolate enriched in epicatechin (a component of dark chocolate) to improve the structural and functional features of mitochondria in two groups
- Patients with heart failure (HF) and type 2 diabetes (DM2) and
- Normal yet sedentary individuals with impaired baseline exercise capacity (as assessed by VO2 max)
We propose that a 3 month treatment with dark chocolate will lead to a significant improvement in exercise capacity which will be secondary to the improvement in skeletal muscle structure from epicatechin.
详细描述
The flavanol epicatechin (which is derived from cocoa and has no known toxicity in humans) has been shown in clinical trials to increase levels of nitric oxide (NO) as assessed by flow-mediated dilation (FMD) in the brachial artery and measurements of circulating NO in plasma. NO is thought to be an activator of PGC-1 alpha [PPAR (peroxisome proliferator-activated receptor) alpha coactivator 1] which stimulates mitochondrial biogenesis. In both patients with heart failure and diabetes there is nitric oxide deficiency and mitochondrial dysfunction. In our proposed double-blinded placebo controlled clinical trial, we will test the hypothesis that chronic administration of epicatechin to patients with both heart failure and diabetes will increase levels of NO and PGC-1 alpha leading to increased mitochondrial biogenesis and improved mitochondrial function. We believe similar changes will occur in sedentary individuals.
In a preliminary study with 5 patients with heart failure and diabetes (conducted under UCSD IRB protocol number #090688) we have shown that epicatechin enriched dark chocolate improves mitochondrial structure (Taub PR, Ramirez-Sanchez I, Ciaraldi TP, et al. Alterations in Skeletal Muscle Indicators of Mitochondrial Structure and Biogenesis in Patients with Type 2 Diabetes and Heart Failure: Effects of Epicatechin Rich Cocoa. Clin Transl Sci. 2011;5(1):43-47.)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, inactive individuals
- •BMI 27-32
排除标准
- •Smoking or quit smoking less than 1 year prior to enrollment
- •Currently taking Coumadin or Pradaxa.
- •Heart failure and diabetes patients:
- •Inclusion Criteria:
- •Medically diagnosed with heart failure and diabetes
- •No significant HbA1C fluctuations in past 6 months
- •Exclusion Criteria:
- •Currently taking Insulin
- •Currently taking Coumadin or Pradaxa.
- •Smoking or quit smoking less than 1 year prior to enrollment
结局指标
主要结局
Change from baseline in pre-specified biomarker levels in blood, skeletal muscle, and urine
时间窗: Baseline and 3 months
Skeletal muscle biopsies and blood draws will be performed to obtain experimental samples.
Change from baseline in exercise capacity
时间窗: Baseline and 3 months
Objectively evaluate exercise capacity through cycle ergometry to measure VO2 max.
Change from baseline in skeletal muscle metabolism
时间窗: Baseline and 3 months
The change in skeletal muscle metabolism will be evaluated by magnetic resonance spectroscopy
次要结局
未报告次要终点
研究者
Pam Taub, MD
Assistant Professor of Medicine
University of California, San Diego