Jayawardena Ranil, Fernando Pasindu, Lokunarangoda Niroshan, Pathirana Anidu Keerthi
Department of Physiology, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka.
Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, QLD, Australia.
Trials. 2017 Jul 10;18(1):314. doi: 10.1186/s13063-017-2057-6.
Cardiovascular disease remains the leading cause of morbidity and mortality worldwide, and there is a rising global burden. The effects of diet on cardiometabolic risk factors have been studied extensively. Healthy eating as a cost-effective approach to risk reduction in post-myocardial infarction patients is proven to be beneficial, and the "plate model" is one of the practical methods to achieve this objective.
METHODS/DESIGN: The study will be conducted as a randomized, single-blind, controlled clinical trial for a period of 3 months. A total of 120 overweight (body mass index >23 kg/m) inpatients (aged 20-70 years) with a history of troponin-positive acute coronary syndrome (ACS) within the 1 month preceding the study will be recruited. Simple randomization will be used in participant allocation. The intervention group will receive the model plate diet. The control group will be provided with routine dietary advice. Other domains, such as advice on exercise and lifestyle modification, will be equalized among patients in both the groups. The visits and evaluations will be done at recruitment (visit 0), 4 weeks, and 12 weeks after the intervention. The primary outcome will be a mean body weight reduction of 10%, and the secondary outcomes will include mean reduction of systolic and diastolic blood pressure, improvement of anthropometric parameters, and improvement of lipid profile and liver enzymes in the test group compared with the control group at 12 weeks following the plate model diet.
This study protocol is designed to establish the effects of the plate model diet on modification of cardiometabolic risk factors in patients with ACS. This will also be a pioneering study designed to investigate the practicality of the model plate in local settings and in the South Asian region.
Sri Lanka Clinical Trials Registry identifier: SLCTR/2016/22. Registered on 22 September 2016 ( http://www.slctr.lk/trials/483 ).
心血管疾病仍是全球发病和死亡的主要原因，且全球负担不断加重。饮食对心脏代谢危险因素的影响已得到广泛研究。健康饮食作为心肌梗死后患者降低风险的一种经济有效的方法，已被证明是有益的，而“餐盘模型”是实现这一目标的实用方法之一。
方法/设计：本研究将作为一项随机、单盲、对照临床试验进行，为期3个月。将招募120名超重（体重指数>23kg/m）的住院患者（年龄20 - 70岁），这些患者在研究前1个月内有肌钙蛋白阳性急性冠状动脉综合征（ACS）病史。参与者分配将采用简单随机化。干预组将接受餐盘模型饮食。对照组将获得常规饮食建议。两组患者在运动和生活方式改变等其他方面的建议将保持一致。在招募时（访视0）、干预后4周和12周进行访视和评估。主要结局将是平均体重减轻10%，次要结局将包括收缩压和舒张压的平均降低、人体测量参数的改善，以及在餐盘模型饮食12周后，与对照组相比，试验组血脂谱和肝酶的改善。
本研究方案旨在确定餐盘模型饮食对ACS患者心脏代谢危险因素改变的影响。这也将是一项开创性研究，旨在调查该模型餐盘在当地和南亚地区的实用性。
斯里兰卡临床试验注册标识符：SLCTR/2016/22。于2016年9月22日注册（http://www.slctr.lk/trials/483）。
