Xie Wuxiang, Wang Yanfang, Sun Jianqin, Zeng Guo, Zhu Huilian, Yang Zhenquan, Gao Pei, Yang Jing, Feng Lin, Lin Pao-Hwa, Li Ming, Xu Jianguo, Chen Junshi, Wu Yangfeng
Peking University Clinical Research Institute, Peking University First Hospital, Beijing, China.
Peking University Clinical Research Institute, Peking University Health Science Center, Beijing, China
BMJ Open. 2020 Aug 20;10(8):e036394. doi: 10.1136/bmjopen-2019-036394.
Unhealthy diet has been identified as the number one attributor of total mortality in China, accounting for more than 20% of total deaths. Although the Dietary Approach to Stop Hypertension (DASH) and Mediterranean diets have been proven beneficial in managing cardiovascular risk factors in Western countries, whether healthy diets with similar cardiovascular benefits can be developed that are consistent with Chinese food culture remains unknown.
METHODS/DESIGN: The Diet, ExerCIse and CarDiovascular hEalth (DECIDE)-Diet trial is a multicentre, single-blind, randomised controlled feeding trial to evaluate the effect of the Chinese Healthy Heart (CHH) diet, in comparison with the Chinese usual diet, in lowering cardiovascular risk factors among community residents with the increased cardiovascular risk. A total of 360 adults aged between 25 and 75 years old and with systolic blood pressure between 130 and 159 mm Hg will be recruited from four centres located in four areas representing four major Chinese cuisines: Beijing, Shanghai, Guangzhou and Chengdu. After 1 week of run-in period with local usual diet, the compliant participants will be randomised to the intervention group with the CHH diet or the control group with the usual local diet, on a 1:1 ratio, for 4 weeks. Body weight of study participants will be maintained during the entire study period. The primary outcome is the change in SBP from the baseline to the end of the study. DECIDE-Diet trial will be the first randomised controlled feeding trial to evaluate the effect of a CHH diet in lowering cardiovascular risk factors. This trial will provide compelling evidence on the CHH diet in effect of improving cardiovascular health among Chinese food consumers all around the world.
This trial adheres to the Declaration of Helsinki and guidelines of Good Clinical Practice. Signed informed consent will be obtained from all participants. The trial has been approved by the Peking University Institutional Review Board (approval number: IRB00001052-18094). The results will be disseminated through academic conferences and publications in international peer-reviewed journals.
ClinicalTrials.gov Registry (NCT03882645); Pre-results.
不健康饮食已被确定为中国全因死亡率的首要归因因素，占总死亡人数的20%以上。尽管已证明终止高血压饮食法（DASH）和地中海饮食对西方国家心血管危险因素的管理有益，但能否开发出与中国饮食文化相符且具有类似心血管益处的健康饮食仍不明确。
方法/设计：饮食、运动与心血管健康（DECIDE）-饮食试验是一项多中心、单盲、随机对照喂养试验，旨在评估中国健康心脏（CHH）饮食与中国常规饮食相比，对心血管风险增加的社区居民降低心血管危险因素的效果。将从代表中国四大菜系的四个地区（北京、上海、广州和成都）的四个中心招募总共360名年龄在25至75岁之间、收缩压在130至159毫米汞柱之间的成年人。在采用当地常规饮食进行1周的导入期后，依从性好的参与者将按1:1的比例随机分为接受CHH饮食的干预组或接受当地常规饮食的对照组，为期4周。在整个研究期间，研究参与者的体重将保持稳定。主要结局是从基线到研究结束时收缩压的变化。DECIDE-饮食试验将是首个评估CHH饮食降低心血管危险因素效果的随机对照喂养试验。该试验将为CHH饮食对全球中国饮食消费者心血管健康改善效果提供有力证据。
本试验遵循《赫尔辛基宣言》和良好临床实践指南。将获得所有参与者签署的知情同意书。该试验已获得北京大学机构审查委员会批准（批准号：IRB00001052-18094）。研究结果将通过学术会议和在国际同行评审期刊上发表进行传播。
ClinicalTrials.gov注册库（NCT03882645）；预结果。
