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澳大利亚地中海饮食心脏研究(AUSMED 心脏研究):多民族澳大利亚人群二级预防冠心病的随机临床试验:研究方案。

The AUStralian MEDiterranean Diet Heart Trial (AUSMED Heart Trial): A randomized clinical trial in secondary prevention of coronary heart disease in a multiethnic Australian population: Study protocol.

机构信息

Department of Rehabilitation, Nutrition and Sport, La Trobe University, Bundoora, Australia; Reprint requests: Catherine Itsiopoulos, PhD, APD, La Trobe University, Bundoora, VIC 3086, Australia..

Department of Rehabilitation, Nutrition and Sport, La Trobe University, Bundoora, Australia.

出版信息

Am Heart J. 2018 Sep;203:4-11. doi: 10.1016/j.ahj.2018.05.010. Epub 2018 May 24.

DOI:10.1016/j.ahj.2018.05.010
PMID:29966802
Abstract

The Mediterranean diet was first characterized as a heart-protective diet in the 1960s. The significant cardioprotective effects of the Mediterranean diet in comparison to the standard-care low-fat diet have been established in the primary prevention of cardiovascular disease (CVD); however, there is insufficient evidence in secondary prevention research to influence the current standard of care. Opportunity exists to assess the Mediterranean diet as a therapeutic target for secondary CVD prevention within Australia's ethnoculturally diverse communities. The AUSMED Heart Trial is a multisite randomized controlled trial that will evaluate the efficacy of the Mediterranean diet for secondary prevention of CVD in the Australian health care setting. This trial aims to evaluate the effect of a 6-month Mediterranean diet intervention (delivered by dietitians) versus a "standard-care" low-fat diet in reducing the composite incidence of cardiovascular events at 12 months and at trial end in participants with documented evidence of a previous acute myocardial infarction at trial entry. The quality of the diet at baseline and follow-up will be assessed using comprehensive dietary questionnaires and diaries as well as relevant dietary biomarkers (such as urinary polyphenols and erythrocyte fatty acids). Cardiovascular risk markers, including novel measures of immune and inflammatory status, endothelial function, vascular compliance, platelet activity, and body composition, will be collected to explore possible mechanisms for treatment effect. Cost-effectiveness will also be estimated to support policy translation. We plan to recruit 1,032 participants (516 per arm) from cardiology clinics in major Australian hospitals in Melbourne, Adelaide, and Brisbane.

摘要

地中海饮食最初在 20 世纪 60 年代被描述为一种保护心脏的饮食。与标准的低脂低热量饮食相比,地中海饮食在心血管疾病(CVD)的一级预防中具有显著的心脏保护作用;然而,在二级预防研究中,没有足够的证据来影响当前的标准护理。在澳大利亚民族文化多样化的社区中,将地中海饮食评估为二级 CVD 预防的治疗目标是有机会的。AUSMED 心脏试验是一项多地点随机对照试验,将评估地中海饮食对澳大利亚医疗保健环境中二级 CVD 预防的疗效。该试验旨在评估为期 6 个月的地中海饮食干预(由营养师提供)与“标准护理”低脂饮食在减少 12 个月和试验结束时心血管事件综合发生率的效果,在试验开始时有先前急性心肌梗死病史的参与者。将使用综合饮食问卷和日记以及相关饮食生物标志物(如尿多酚和红细胞脂肪酸)来评估基线和随访时的饮食质量。将收集心血管风险标志物,包括免疫和炎症状态、内皮功能、血管顺应性、血小板活性和身体成分的新措施,以探索治疗效果的可能机制。还将估计成本效益,以支持政策转化。我们计划从墨尔本、阿德莱德和布里斯班的澳大利亚主要医院的心脏病学诊所招募 1032 名参与者(每组 516 名)。

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