DIETARY PATTERNS, SODIUM INTAKE, AND BLOOD PRESSURE

DASH 2是一项多中心、随机临床试验，旨在比较 三种钠摄入水平和两种饮食模式对 血压. 此协调中心应用程序是一个 来自五个参与机构的协调申请 机构职能体系 这两种饮食模式是一种~控制饮食~即 典型的美国人通常吃什么和~组合饮食~， 富含水果、蔬菜、纤维和低脂乳制品， 减少总脂肪、饱和脂肪和胆固醇含量。 钠 水平从高（反映美国目前的消费）到中等 （反映目前的建议），至低（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， 平行组设计，并在每个钠水平下使用 交叉设计 研究参与者（n=400）是22岁的成年人， 年龄较大，舒张压正常偏高。 1期（轻度） 高血压 基线范围为159/95。 一半的参与者是 美国人，一半是女性。 参加者将参加一系列 三次合格性筛选访视，然后进行为期两周的导入喂养 期间和三个为期一个月的干预喂养期， 三种钠水平。 该研究为参与者提供了所有 他们的食物在磨合期和干预喂养期，虽然 参与者恢复正常饮食长达五天， 三个干预喂养期。 在受控的 参加者需要在 每周五天，每天至少一餐，并带回家吃 其他的食物。 诊所提供四种干预措施 连续队列，每个队列约有25名随机化受试者 在两年的时间里， 为了支持审判， 协调中心：准备和分发所有研究文件， 包括方案、程序手册和研究表格;设计 并实施数据管理系统;监测和报告审判情况 进展;制定和实施试验范围内的质量控制程序; 与中央实验室和食品分析实验室联系， 提供血液，尿液和食物成分的分析;开发 随机化研究参与者的机制;龋齿数据分析 进行现场考察;组织中心培训， 对工作人员进行认证;建立全审判制度 通信;并为审判提供后勤支助。 的 拟议的DASH 2试验扩展了对钠摄入量和饮食的研究 模式来解决与临床非常相关的几个问题 实践和公共卫生。 减少钠，再加上饮食 模式，有很大的希望，以降低血压的程度迄今 未证实用于任何非药物治疗，可能是 1期高血压患者药物治疗的替代方案，或 正常高血压 对于中度至重度 高血压，它可以减少药物需求和简化治疗。

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.