Vascular Effects of Dietary Salt in Humans With Salt-Resistant Blood Pressure: Dietary Counseling Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Reflected Pulse Wave Amplitude
研究概览
简要总结
The purpose of this study is to determine the effects of dietary salt restriction on central hemodynamics and vascular function in men and women with salt resistant blood pressure.
详细描述
Cardiovascular disease remains a major Public Health problem and is the leading cause of death in the US. Dietary sodium restriction is considered an important lifestyle modification for individuals with hypertension; however, there is controversy about the effects of dietary salt given that many individuals do not have "salt sensitive" blood pressure. Deleterious effects of salt on the vasculature may explain the finding that chronic DSR reduces the cardiovascular event rate by 25%despite only minor reductions in BP. It is not known whether dietary sodium restriction improves central pulsatile hemodynamics, known to be related to the development of left ventricular hypertrophy and heart failure risk, and whether the hypothesized improvements in central hemodynamics are similar in men & women. The purpose of this study is to determine the effects of dietary sodium restriction through dietary counseling on central hemodynamics and vascular function in men and women with salt resistant blood pressure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Habitual dietary sodium intake > 3400mg per day
排除标准
- •Abnormal resting ECG
- •Current abnormal blood panel (assessed by comprehensive metabolic panel, lipid panel and complete blood count).
- •Hypertension (currently taking anti-hypertensive medications or resting blood pressure >140/90 mmHg)
- •Medical history of cardiovascular disease, malignant cancer, diabetes or kidney disease
- •Obesity (Body Mass Index > 30)
- •Current pregnancy
- •Unable to provide consent
研究组 & 干预措施
Dietary Sodium Restriction
Daily habitual dietary sodium intake < 2000mg
干预措施: Dietary Sodium Restriction (Other)
Control
Routine habitual dietary sodium intake >3400mg
干预措施: Control (Other)
结局指标
主要结局
Reflected Pulse Wave Amplitude
时间窗: Change from baseline at 4 weeks
Late systolic pulsatile load on the left ventricle represented by reflected pulse wave amplitude; assessed by echocardiography combined with applanation tonometry.
次要结局
- Forward pulse wave amplitude(Change from baseline at 4 weeks)
- Conduit Artery Endothelial Dependent Dilation(Change from baseline at 4 weeks)
- Microvascular Function(Change from baseline at 4 weeks)
- Arterial Stiffness(Change from baseline at 4 weeks)
研究者
William Farquhar
Professor
University of Delaware