DIETARY PATTERNS, SODIUM INTAKE, AND BLOOD PRESSURE

DASH2是一项多中心随机临床试验，旨在比较 三种钠摄入量水平和两种膳食结构对健康的影响 血压。此协调中心应用程序是 来自五个参与方的一套协调的申请 机构。这两种饮食模式是~控制饮食~也就是 典型的美国人通常吃的食物和~组合饮食~也就是 富含水果、蔬菜、纤维和低脂乳制品， 降低总脂肪、饱和脂肪和胆固醇含量。钠 水平从高(反映美国当前的消费)到中等 (反映当前建议)、到低(反映潜在的 最佳水平)，并根据卡路里水平略有不同。 参与者被分配到两种饮食模式之一，使用 平行分组设计，在每个钠水平上使用 跨界设计。研究参与者(n=400)是成年人，年龄22岁和 年龄较大，正常舒张压较高。阶段1(轻微) 高血压。基线范围为159/95。一半的参与者是 非裔美国人和一半是女性。参与者参加了一系列 三次资格筛选访问，然后进行为期两周的磨合喂养 期间和三个为期一个月的干预喂养期 三个钠的水平。这项研究为参与者提供了所有 它们在磨合和干预喂食期的食物，尽管 参与者在两人之间恢复正常饮食长达五天 在三个干预喂养期中。在受控期间 哺乳期间参加者须到诊所就诊。 每周五天，每天至少吃一顿饭，并把食物带回家吃 为他们的其他餐点。诊所提供四种干预措施 连续队列，每个队列约有25名随机参与者 队列，在两年的时间里。为了支持审判， 协调中心：准备并分发所有研究文件， 包括协议、程序手册和研究表格；设计 并实施数据管理系统；监测和报告试验情况 进展；制定和实施试验范围内的质量控制程序； 与中心实验室和食品分析实验室联系，以 提供血液、尿液和食物样本的分析；开发一种 对研究参与者进行随机化的机制；数据分析 进行现场考察；组织中央培训和 对工作人员进行认证；建立审判范围的制度 通信；并为审判提供后勤支助。这个 拟议的DASH2试验延长了对钠摄入量和饮食的研究 解决与临床非常相关的几个问题的模式 实践和公共卫生。钠的减少，再加上饮食 到目前为止，这种模式在一定程度上降低了血压 未显示为任何非药物性治疗，并且可能是 1期高血压患者的替代药物治疗或 正常血压偏高。适用于中至重度患者 对于高血压来说，它可能会减少药物需求，简化治疗。

DASH2 is a multi-center, randomized clinical trial designed to compare the effects of three levels of sodium take and two dietary patterns on blood pressure. This coordinating center application is one of a coordinated set of applications from the five participating institutions. The two dietary patterns are a ~control diet~ that is typical of what Americans generally eat and a ~combination diet~ that is high in fruits, vegetables, fiber and low-fat dairy products and has a reduced total fat, saturated fat, and cholesterol content. The sodium levels range from high (reflecting current US consumption), to medium (reflecting current recommendations), to low (reflecting potentially optimal levels) and vary slightly according to calorie level. Participants are assigned to one of the two dietary patterns using a parallel group design, and are fed at each sodium level using a crossover design. Study participants (n=400) are adults, aged 22 and older, with high normal diastolic blood pressure . Stage 1 (mild) hypertension. Baseline range from 159/95. Half of the participants are African American and half are female. Participants attend a series of three eligibility screening visits followed by a tow-week run-in feeding period and three one-month intervention feeding periods one at each of the three sodium levels. The study provides participants with all of their food during the run-in and intervention feeding periods, although participants resume their normal diets for up to five days between each of the three intervention feeding periods. During the controlled feeding periods participants are required to attend the clinic for at least one meal per day, five days per week, and take home food to eat for their other meals. Clinics deliver the interventions in four successive cohorts, with approximately 25 randomized participants per cohort, over a tow-year period. In support of the trial, the coordinating center: prepares and distributes all study documents, including the protocol, manual of procedures, and study forms; designs and implements a data management system; monitors and reports on trial progress; develops and implements trialwide quality control procedures; contacts with a central laboratory and a food analysis laboratory to provide analysis of blood, urine, and food speciments; develops a mechanism for randomizing study participants; caries out data analysis for the trial; conduct site visits; organizes central training and certification of staff; establishes a system of trialwide communications; and provides logistical support to the trial. The proposed DASH2 trial extends research on sodium intake and dietary patterns to address several issues of great relevance to clinical practice and public health. Sodium reduction, coupled with the dietary pattern, has great promise to lower blood pressure to an extent hitherto not demonstrated for any nonpharamacologic treatment and may be an alternative to drug therapy for persons with stage 1 hypertension or high normal blood pressure. For persons with moderate-to-severe hypertension, it may reduce medication requirements and simplify treatment.