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临床试验/NCT04325191
NCT04325191Unknown不适用

Melatonin and Salt on Blood Vessel Function

University of Delaware2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2020年3月12日最近更新:
适应症

试验速览

阶段
不适用
入组人数
15
试验地点
2
主要终点
Microvascular function

研究概览

简要总结

Increased dietary sodium causes increases in oxidative stress and damages blood vessels. Americans eat more than the recommended amount of sodium. Melatonin is a powerful endogenous antioxidant that has reduced oxidative stress levels in clinical and healthy populations. This study will investigate whether melatonin can attenuate the negative effects of sodium on blood vessels.

详细描述

Americans consume on average double the recommended amount of sodium established by organizations such as the American Heart Association and the Dietary Guidelines for Americans. Excess dietary sodium damages the inside of our blood vessels in a process known as endothelial dysfunction. This reduces the ability of blood vessels to dilate as much. This type of dysfunction can lead to the development of cardiovascular disease. Animal and human studies have identified one potential mechanism linking high sodium consumption and endothelial dysfunction; that is oxidative stress. Furthermore, high dietary sodium consumption has been shown to increase blood pressure reactivity in animal studies. Melatonin is a powerful endogenous antioxidant that has reduced oxidative stress levels in clinical and healthy populations. Melatonin has been shown to attenuate sympathetic responses, but research is limited. Whether supplementation of melatonin can offset the deleterious effects of a high sodium diet is unknown. Thus, the purpose of this study is to investigate the effect of melatonin supplementation compared to a placebo on markers of oxidative stress and blood vessel function in healthy young adults that consume a 10-day high sodium diet. Our hypotheses are that: 1) melatonin will reduce oxidative stress levels and restore blood vessel function and 2) melatonin will reduce the sympathetic nerve response to high sodium consumption.

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

Participant will not know if they are receiving the melatonin or placebo pills.

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

  • normal blood pressure

排除标准

  • hypertension
  • heart disease
  • kidney disease
  • renal impairment
  • obese (BMI ≥30)
  • sleep disorder
  • use of tobacco products
  • pregnant or breastfeeding
  • take any medications for the above conditions
  • endurance trained athletes
  • night shift worker
  • melatonin or antioxidant consumption for the previous 3 months
  • use of selective serotonin reuptake inhibitors

结局指标

主要结局

Microvascular function

时间窗: Day 10

Assessed by Near Infrared Spectroscopy (NIRS)

Conduit artery endothelial-dependent function

时间窗: Day 10

Assessed by brachial artery flow mediated dilation (FMD)

次要结局

  • Blood pressure reactivity(Day 10)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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