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临床试验/NCT05887622
NCT05887622招募中不适用

The Role of Potassium Supplementation on Endothelial Function, BP Regulation, and Oxidative Stress Under High Sodium Conditions

University of Delaware2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年1月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
2
主要终点
Conduit artery endothelial dependent dilation

研究概览

简要总结

This study will test whether potassium supplementation can reduce the deleterious effect of a high sodium diet on blood vessel function, blood pressure reactivity and autonomic nervous system function in apparently healthy adults.

详细描述

Excess sodium intake is linked to poor blood pressure (BP) regulation and endothelial dysfunction, both of which are implicated in the pathogenesis of atherosclerosis and high BP. Evidence suggests potassium may offset the damaging effects of sodium; however, studies in healthy adults are lacking. This is important as these pre-clinical risk factors have been observed in this population, suggesting early intervention may be critical for cardiovascular disease prevention. High potassium diets have been effective at attenuating a sodium-induced decline in endothelial function. However, potassium intake was increased using whole foods; thus, the vascular benefits cannot be attributed solely to potassium. Furthermore, whether potassium can reduce sodium-induced oxidative stress is unknown. The central hypothesis of this study is that endothelial function will be greater and BP reactivity and oxidative stress will be lower with a high potassium intake compared to a low potassium intake, in the context of a high sodium diet. The investigators will assess macrovascular function using flow-mediated dilation, BP reactivity using the cold pressor test and isometric handgrip grip test, and oxidative stress using electron paramagnetic resonance.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Single (Participant)

盲法说明

Participants will be blinded to the diet they are on.

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • men and women
  • 18-45 years of age
  • all races/ethnicities
  • BMI < 30 kg/m2
  • BP < 130/80 mmHg

排除标准

  • presence of hypertension
  • known heart disease
  • kidney disease
  • inflammatory conditions
  • blood clotting disorders
  • pregnancy
  • adrenal gland disorder
  • history of stomach or intestinal bleeding
  • history of kidney stones
  • serum potassium outside of the normal range

研究组 & 干预措施

Moderate potassium/low sodium

Experimental

Subjects will consume a diet moderation in potassium and low in sodium.

干预措施: Placebo (Dietary Supplement)

Moderate potassium/high sodium

Experimental

Subjects will consume a diet moderation in potassium and high in sodium.

干预措施: Placebo (Dietary Supplement)

High potassium/high sodium

Experimental

Subjects will consume a diet moderation in potassium and high in sodium.

干预措施: Potassium chloride supplement (Dietary Supplement)

结局指标

主要结局

Conduit artery endothelial dependent dilation

时间窗: on day 10 of each diet

The difference in flow-mediated dilation (FMD) between the 3 diets

Blood pressure reactivity

时间窗: on day 10 of each diet

The change in both systolic and diastolic blood pressure during handgrip exercise and cold pressor test from baseline

Superoxide levels

时间窗: on day 10 of each diet

The difference in superoxide levels as measured by electronic paramagnetic resonance (EPR) between the 3 diets will be assessed

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shannon Lennon

Associate Professor

University of Delaware

研究点 (2)

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