RATIONALE Cocoa and its major flavanol component, epicatechin, have therapeutic properties that may improve limb perfusion and increase calf muscle mitochondrial activity in people with lower extremity peripheral artery disease (PAD). OBJECTIVE In a phase II randomized clinical trial, to assess whether 6 months of cocoa improved walking performance in people with PAD, compared with placebo. METHODS AND RESULTS Six-month double-blind, randomized clinical trial in which participants with PAD were randomized to either cocoa beverage versus placebo beverage. The cocoa beverage contained 15 g of cocoa and 75 mg of epicatechin daily. The identical appearing placebo contained neither cocoa nor epicatechin. The 2 primary outcomes were 6-month change in 6-minute walk distance measured 2.5 hours after a study beverage at 6-month follow-up and 24 hours after a study beverage at 6-month follow-up, respectively. A 1-sided P<0.10 was considered statistically significant. Of 44 PAD participants randomized (mean age, 72.3 years [±7.1]; mean ankle brachial index, 0.66 [±0.15]), 40 (91%) completed follow-up. Adjusting for smoking, race, and body mass index, cocoa improved 6-minute walk distance at 6-month follow-up by 42.6 m ([90% CI, +22.2 to +∞] P=0.005) at 2.5 hours after a final study beverage and by 18.0 m ([90% CI, -1.7 to +∞] P=0.12) at 24 hours after a study beverage, compared with placebo. In calf muscle biopsies, cocoa improved mitochondrial COX (cytochrome c oxidase) activity (P=0.013), increased capillary density (P=0.014), improved calf muscle perfusion (P=0.098), and reduced central nuclei (P=0.033), compared with placebo. CONCLUSIONS These preliminary results suggest a therapeutic effect of cocoa on walking performance in people with PAD. Further study is needed to definitively determine whether cocoa significantly improves walking performance in people with PAD. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT02876887. Visual Overview: An online visual overview is available for this article.

中文翻译：

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可可改善患有外周动脉疾病的老年人的步行性能：COCOA-PAD飞行员随机临床试验。

RATIONALE可可豆及其主要黄烷醇成分表儿茶素具有治疗性能，可改善下肢周围动脉疾病（PAD）患者的肢体灌注并增加小腿肌肉线粒体活性。目的在一项II期随机临床试验中，评估6个月可可粉与安慰剂相比是否能改善PAD患者的行走能力。方法和结果为期六个月的双盲，随机临床试验，其中将PAD受试者随机分为可可饮料和安慰剂饮料。可可饮料每天包含15克可可和75毫克表儿茶素。出现相同的安慰剂既不含可可也不含表儿茶素。2个主要结局是6分钟步行距离的6个月变化2。在6个月的随访中研究饮料后5小时和6个月的随访中研究饮料后24小时。单侧P <0.10被认为具有统计学意义。在随机分组的44名PAD参与者中（平均年龄为72.3岁[±7.1]；平均踝肱指数为0.66 [±0.15]），其中40名（91％）完成了随访。根据吸烟，种族和体重指数进行调整，可可可在最后6个月的2.5小时内，在6个月的随访中将6分钟的步行距离提高了42.6 m（[90％CI，+ 22.2至+∞] P = 0.005）。与安慰剂相比，在研究饮料后24小时增加18.0 m（[90％CI，-1.7至+∞] P = 0.12）[18]。在小腿肌肉活检中，可可改善了线粒体COX（细胞色素C氧化酶）活性（P = 0.013），毛细血管密度增加（P = 0.014），小腿肌肉灌注改善（P = 0.098）和中央核减少（P = 0.033），与安慰剂相比。结论这些初步结果表明可可对PAD患者的步行性能具有治疗作用。需要进一步的研究来确定可可是否能显着改善PAD患者的步行能力。临床试验注册网址：http://www.clinicaltrials.gov。唯一标识符：NCT02876887。视觉概述：本文提供了在线视觉概述。