可可粉改善外周动脉疾病老年人的步行能力：COCOA-PAD 先导随机临床试验。
Cocoa to Improve Walking Performance in Older People With Peripheral Artery Disease: The COCOA-PAD Pilot Randomized Clinical Trial.
机构信息
From the Departments of Medicine (M.M.M., K.D., L.L., D.L.-J., D.Z.), Northwestern University Feinberg School of Medicine, Chicago, IL.
Preventive Medicine (M.M.M., D.L.-J., L.V.H., L.Z.), Northwestern University Feinberg School of Medicine, Chicago, IL.
出版信息
Circ Res. 2020 Feb 28;126(5):589-599. doi: 10.1161/CIRCRESAHA.119.315600. Epub 2020 Feb 14.
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 <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 +∞] =0.005) at 2.5 hours after a final study beverage and by 18.0 m ([90% CI, -1.7 to +∞] =0.12) at 24 hours after a study beverage, compared with placebo. In calf muscle biopsies, cocoa improved mitochondrial COX (cytochrome c oxidase) activity (=0.013), increased capillary density (=0.014), improved calf muscle perfusion (=0.098), and reduced central nuclei (=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.
背景
可可及其主要黄烷醇成分表儿茶素具有治疗作用，可能改善下肢外周动脉疾病（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，评估与安慰剂相比，6 个月的可可是否能改善 PAD 患者的步行表现。
方法和结果
为期 6 个月的双盲、随机临床试验中，将 PAD 患者随机分为可可饮料组与安慰剂饮料组。可可饮料每日含 15 克可可和 75 毫克表儿茶素。外观相同的安慰剂既不含可可也不含表儿茶素。主要终点分别为 6 个月时研究饮料后 2.5 小时和 6 个月时研究饮料后 24 小时的 6 分钟步行距离的变化。单侧<0.10 被认为具有统计学意义。44 名 PAD 参与者（平均年龄 72.3 岁[±7.1]；平均踝肱指数 0.66[±0.15]）随机分组，40 名（91%）完成了随访。调整吸烟、种族和体重指数后，与安慰剂相比，可可饮料可使 6 个月时 2.5 小时后的 6 分钟步行距离增加 42.6 米（[90%CI，+22.2 至+∞] =0.005），增加 18.0 米（[90%CI，-1.7 至+∞] =0.12），24 小时后饮用研究饮料。在小腿肌肉活检中，与安慰剂相比，可可改善了线粒体 COX（细胞色素 c 氧化酶）活性（=0.013），增加了毛细血管密度（=0.014），改善了小腿肌肉灌注（=0.098），减少了中央核（=0.033）。
结论
这些初步结果提示可可对 PAD 患者的步行表现具有治疗作用。需要进一步的研究来确定可可是否能显著改善 PAD 患者的步行表现。
临床试验注册
网址：http://www.clinicaltrials.gov。唯一标识符：NCT02876887。在线可视化概述：本文提供了在线可视化概述。
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