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Efficacy of Dietary Sodium Restriction of Improving Vascular Endothelial Function in Middle Aged and Older Adults

2015年12月4日 更新者：Douglas Seals、University of Colorado, Boulder
The investigators hypothesize that reducing salt in the diet will improve the function of blood vessels in middle aged and older adults with moderately elevated systolic blood pressure, by increasing the amount of BH4 and nitric oxide in your blood vessels and reducing the amount of oxidative stress.

研究概览

地位

完全的

条件

干预/治疗

详细说明

The improvement in blood vessel function will be determined over a 10 week period. Subjects will be randomly assigned to either a 'low salt' condition (placebo pills + 1200 mg dietary sodium) or a 'normal salt' condition (2300 mg sodium chloride pills + 1200 mg dietary sodium) and monitored for 5 weeks. After the initial set of 5 weeks, the subjects are switched into the opposite condition, completing the cross-over study design. During weeks 1-4 and 6-9, subjects are monitored weekly with 24 hour urine collections and diet logs. The assessment of the primary outcome (blood vessel function) is completed during weeks 5 and 10. BH4 and ascorbic acid are also administered during weeks 5 and 10 to measure the effects of sodium intake on endogenous BH4 levels and vascular oxidative stress.

研究类型

介入性

注册 (实际的)

17

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

  • 美国
    • Colorado
      • Boulder、Colorado、美国、80309
        • Clinical Translational Research Center

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

50年 至 79年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 50-79 years of age
  • SBP 130-159 mmHg

Exclusion Criteria:

  • Have been sick with an infection in the past two weeks
  • Are currently sick or have ongoing health problems such as kidney or CVD
  • Have lost more than 11 lbs. in the last 3 months
  • Are taking any type of antioxidants
  • Smoke or have alcohol problems
  • Have blood glucose levels higher than 126 mg/dL
  • Have resting SBP below or less than 100 mmHg or greater than 159 mmHg
  • Have a resting diastolic blood pressure greater than 99 mmHg
  • Have a BMI greater than 40 kg/m^2
  • Are presently consuming less than 9 or greater than 18 grams of salt / day
  • Have a baseline FMD of greater than 6%
  • Are taking any of the following types of drugs: blood thinners, anti-seizure medications, ant-inflammatory drugs
  • Participate in any high endurance athletic training
  • Taking Hormone Replacement Therapy
  • Have not been post-menopausal for at least 1 year

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：治疗
  • 分配：随机化
  • 介入模型：交叉作业
  • 屏蔽：三倍

武器和干预

参与者组/臂
干预/治疗
其他：Normal sodium
Subjects on a 1200 mg sodium diet are given 2300 mg sodium in the form of slow sodium tablets to bring them back up to a normal salt intake. Subjects then cross-over to the low sodium condition in the second half of the study.
药品：Slow sodium tablets
The normal salt condition is maintained with 2300 mg / day in the form of slowly released salt (NaCl) tablets.
其他：Low sodium
Subjects on a 1200 mg salt diet are given placebo pills in order to maintain them on a low salt diet. Subjects then cross-over to the normal sodium condition in the second half of the study.
其他：placebo
Placebo tablets are administered to maintain the low sodium condition.

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
Improved Flow Mediated Dilation
大体时间：Week 5 (after first condition of low salt or normal salt), Week 10 (after second condition, opposite to first)
FMD is analyzed at weeks 5 and 10 or after each condition in this cross-over study design. Subjects are randomly assigned to a low salt or normal salt condition for the first set of 5 weeks and then crossed over to the other condition for the second set of 5 weeks.
Week 5 (after first condition of low salt or normal salt), Week 10 (after second condition, opposite to first)

次要结果测量

结果测量
措施说明
大体时间
Vascular Oxidative Stress
大体时间：Immediately following acute infusion of ascorbic acid on Weeks 5 and 10
Change in FMD following acute infusion of ascorbic acid (a dose known to scavenge superoxide) is measured at the end of 5 weeks of sodium condition (low and normal intake) as an index of vascular oxidative.
Immediately following acute infusion of ascorbic acid on Weeks 5 and 10
BH4 Bioavailability
大体时间：Immediately following acute administration of BH4 on Weeks 5 and 10
Change in FMD following acute oral tetrahydrobiopterin (BH4) is measured at the end of 5 weeks of sodium condition (low and normal intake) as an index of BH4 bioavailability.
Immediately following acute administration of BH4 on Weeks 5 and 10

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。

赞助

University of Colorado, Boulder

合作者

National Institute on Aging (NIA)

调查人员

  • 首席研究员：Kristen L Jablonski, PhD、University of Colorado, Boulder

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

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

2009年2月1日

初级完成 (实际的)

2012年1月1日

研究完成 (实际的)

2012年1月1日

研究注册日期

首次提交

2012年3月23日

首先提交符合 QC 标准的

2012年3月28日

首次发布 (估计)

2012年3月29日

研究记录更新

最后更新发布 (估计)

2016年1月7日

上次提交的符合 QC 标准的更新

2015年12月4日

最后验证

2015年12月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • B5114
  • F31AG033994 (美国 NIH 拨款/合同)

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.

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