Vascular Effects of Dietary Potassium
2020年11月4日 更新者:University of Delaware
Vascular Effects of Dietary Potassium in Humans
The purpose of this study is to determine if dietary potassium can attenuate the deleterious effects of high sodium on blood vessel function in healthy, salt-resistant participants.
研究概览
地位
完全的
条件
详细说明
Cardiovascular disease remains a major Public Health problem in the U.S. and is the result of diseases such as atherosclerosis and high blood pressure (BP).
Several dietary factors have been implicated as risk factors including high sodium and low potassium diets.
Indeed, it is well known that excess sodium can increase BP while potassium rich diets have BP lowering properties.
While the role of these two nutrients on BP is widely accepted, their impact on the vasculature has received less attention.
Endothelial dysfunction, characterized by impaired dilation is an important non-traditional risk factor for atherosclerosis.
Data in animal models suggest that salt loading, independent of changes in BP, results in endothelial dysfunction while evidence is mounting that potassium may be beneficial to vascular health.
Further, potassium may be more effective in the presence of high sodium however the role of potassium in protecting the vasculature from a high sodium diet in salt-resistant adults has not been explored.
A potential mechanism responsible for sodium induced vascular dysfunction is overproduction of reactive oxygen species resulting in reduced nitric oxide (NO) production/ bioavailability.
It has been suggested that potassium can counteract sodium's effect by reducing ROS.
The central hypothesis is that potassium can protect against the deleterious effects of high sodium on the vasculature by reducing oxidative stress and preserving NO.
In this grant, the investigators propose to use a 21-day controlled feeding study to compare the effects of a high sodium diet (300 mmol) combined with either a high (120 mmol) or moderate (65 mmol) amount of potassium and low sodium (50 mmol) combined with moderate potassium (crossover design, diet order sequence randomized) on 2 levels of the vasculature, conduit artery and microvasculature.
These experiments will be performed in salt-resistant participants to study the vascular effects alone, independent of changes in BP.
研究类型
介入性
注册 (实际的)
47
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
Delaware
-
Newark、Delaware、美国、19716
- University of Delaware
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
22年 至 45年 (成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- healthy
- normal blood pressure
Exclusion Criteria:
- hypertension
- history of heart disease
- diabetes
- kidney disease
- obese (BMI ≥30)
- significant weight changes in the last 6 months
- use of tobacco products
- pregnant
- on a special diet (gluten free; vegan)
- take any medications for the above conditions
- endurance trained athletes
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
其他:Moderate Potassium/Low Sodium Diet
Vascular function will be assessed at both the conduit artery and microvascular level after 7 days of the moderate potassium/low sodium diet.
|
7 days of the prescribed diet
|
其他:Moderate Potassium/High Sodium Diet
Vascular function will be assessed at both the conduit artery and microvascular level after 7 days of the moderate potassium/high sodium diet.
|
7 days of the prescribed diet
|
其他:High Potassium/High Sodium Diet
Vascular function will be assessed at both the conduit artery and microvascular level after 7 days of the high potassium/high sodium diet.
|
7 days of the prescribed diet
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Conduit artery endothelial-dependent dilation
大体时间:on the 7th day of each diet
|
The change in flow-mediated dilation (FMD) between the 3 diets as assessed by brachial artery FMD
|
on the 7th day of each diet
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Arterial Stiffness
大体时间:on 7th day of each diet
|
Assessed by carotid to femoral artery pulse wave velocity
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on 7th day of each diet
|
Wave reflection
大体时间:on 7th day of each diet
|
Assessed by augmentation index
|
on 7th day of each diet
|
Endothelial cell expression of oxidative stress marker
大体时间:on the 7th day of each diet
|
Assessed in venous endothelial cells from participants.
|
on the 7th day of each diet
|
Ambulatory blood pressure
大体时间:7 days
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Assessed by 24 hr ambulatory blood pressure monitoring.
|
7 days
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2013年7月25日
初级完成 (实际的)
2019年9月22日
研究完成 (实际的)
2019年9月22日
研究注册日期
首次提交
2017年8月25日
首先提交符合 QC 标准的
2017年8月25日
首次发布 (实际的)
2017年8月29日
研究记录更新
最后更新发布 (实际的)
2020年11月5日
上次提交的符合 QC 标准的更新
2020年11月4日
最后验证
2020年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.