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临床试验/NCT01017484
NCT01017484已完成不适用

Mechanism of the Blood Pressure Lowering Effect of the DASH Dietary Pattern

Duke University0 个研究点目标入组 20 人开始时间: 2007年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
主要终点
urinary sodium

研究概览

简要总结

Understanding the possible mechanism(s) by which the DASH dietary pattern lowers blood pressure will potentially enhance the value of this dietary intervention by elucidating the conditions under which it will be most effective, identifying target populations, examining its impact on vascular health beyond blood pressure, and enhancing the investigators' understanding of the interactions among diet, blood pressure and vascular function. In addition, results of this study may help to identify additional therapeutic targets. Therefore, the overall goal of the proposed study is to determine the mechanism(s) by which the DASH dietary pattern lowers blood pressure by using a controlled feeding design.

详细描述

Randomized, controlled feeding trials have established the BP lowering effects of the Dietary Approaches to Stop Hypertension (DASH) dietary pattern, which emphasizes fruits, vegetables and low fat dairy and is low in saturated and total fat. The DASH studies were designed to establish efficacy, not to determine mechanism of action. Other studies suggest that the DASH diet may have effects on the renin-angiotensin-aldosterone system (RAAS). These effects have not been directly evaluated, nor have other potential mechanisms of action such as effects on adrenergic tone, vascular function and inflammation. The BP-lowering effect of the DASH dietary pattern was maximal after two weeks of controlled feeding, and was comparable in magnitude to antihypertensive medication among participants with stage 1 hypertension. Understanding the possible mechanism(s) by which the DASH diet lowers BP will potentially enhance the value of this intervention by elucidating the conditions under which it will be most effective, identifying target populations, examining its impact on vascular health beyond BP, and enhancing our understanding of the interactions among diet, BP and vascular function. In addition, results of this study may help to identify additional therapeutic targets. Therefore, the overall goal of the proposed study is to determine the mechanism(s) by which the DASH diet lowers BP. Our unifying hypothesis is that DASH diet lowers BP through effects on vascular function and sodium excretion, mediated through the effects on RAAS.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
22 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • SBP 140-159 mm Hg and DBP 90-99 mm Hg based on mean values over two screening visits,
  • Age ≥22 years, and
  • Willing to eat at least one on-site meal/day, five days/week, and willing to eat study diets and nothing else for the 3 weeks of controlled feeding.

排除标准

  • Any serious illness that would interfere with participation or make DASH diet unsafe to the participants,
  • Currently on cancer chemotherapy or with evidence of active malignancy or radiation therapy within past six months,
  • History of CVD event (MI, CABG, angioplasty, symptomatic ischemic heart disease, or stroke),
  • Clinical diagnosis of congestive heart failure,
  • Current diagnosis of diabetes and treatment for diabetes with oral medication or insulin,
  • Body mass index > 45 Kg/m2,
  • DASH MECHANISM staff or household member of DASH MECHANISM staff,
  • Using Medications including BP lowering drugs within the last three months, using lithium,insulin or oral diabetes medications, oral corticosteroids, unstable doses of psychotropics or phenothiazines, antacids or nutritional supplements unless they can be discontinued, or weight reducing medications;
  • Consumption of more than 14 alcoholic drinks per week;
  • Investigator discretion for safety or compliance reasons;
  • Inability to provide reliable BP & vascular functions measurements;
  • Planning to leave the area prior to the anticipated end of the intervention period;
  • Pregnant, planning a pregnancy prior to the end of intervention, or breast feeding;
  • Significant food allergies, preferences, or dietary requirements that would interfere with diet adherence; and
  • Subjects taking medications for erectile dysfunction.

结局指标

主要结局

urinary sodium

时间窗: 2 weeks

次要结局

  • blood pressure(2 weeks)

研究者

申办方类型
Other
责任方
Sponsor

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