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Completed

NCT Number: NCT02881515

Adverse Neurogenic Actions of Dietary Salt

Excess dietary salt increases the risk for cardiovascular events, even in people that are not hypertensive. There is some evidence that excess dietary salt exaggerates blood pressure and sympathetic nervous system responses to various perturbations and increases blood pressure variability. This proposal will examine the effects of low, medium, and high salt diets on cardiovascular reactivity and blood pressure variability.

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Key information

Conditions

Blood Pressure

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Delaware

Newark, Delaware, 19716, United States

About this study

Excess dietary salt causes target organ damage and increases the risk for adverse cardiovascular (CV) events independent of blood pressure (BP). Recent data in salt-resistant, normotensive rodents suggest that high dietary salt enhances the excitability or gain of sympathetic circuits, exaggerates sympathetic and CV responses to various stimuli, and increases BP variability (BPV). There are limited data regarding the impact of dietary salt intake on sympathetic nerve activity (SNA) and CV function in salt-resistant humans as well as the underlying mechanisms contributing to these adverse effects. The long-term goal is to determine how dietary salt adversely affects BP regulation and CV health. The objective of this proposal is to comprehensively evaluate the impact of dietary salt intake on SNA and CV reactivity and BPV in normotensive humans. The investigators have 2 specific aims: 1) Aim 1 will test the hypothesis that high dietary salt increases SNA and CV reactivity in normotensive adults, 2) Aim 2 will test the hypothesis that high dietary salt increases BPV in normotensive adults. The expected outcome is to demonstrate that dietary salt loading increases CV reactivity and BPV through a sympathetic nervous system mechanism that originates in the brain. The proposed research is significant, as these studies will provide empirical evidence that dietary salt intake impacts neurohumoral control of the circulation in salt-resistant humans. The proposed research is innovative because it will identify a novel neurogenic action of dietary salt in human CV regulation.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • normal blood pressure
  • men, Women, minorities
  • ECG within normal limits
  • screening blood panel within normal limits

Exclusion criteria

  • high blood pressure (>140/90 mmHg)
  • history of cardiovascular disease
  • history of cancer
  • history of diabetes
  • history of kidney disease
  • obesity (BMI > 30 kg/m2)
  • smoking or tobacco use
  • current pregnancy
  • nursing mothers
  • communication barriers

Treatment and study plan

Low sodium diet

Other

Ten days of low sodium diet

Medium Sodium Diet

Other

Ten days of a medium sodium diet

high sodium diet

Other

Ten days of a high sodium diet

Primary outcomes

  1. Blood Pressure Variability

    Time frame: Day 10 of diet (i.e., after 10 days of low, medium, and high sodium diets; crossover design)

    Standard deviation of systolic blood pressure over 24 hours (mmHg)

  2. Blood Pressure Reactivity - Handgrip exercise

    Time frame: Day 10 of diet (i.e., after 10 days of low, medium, and high sodium diets; crossover design)

    Change in Blood pressure during handgrip exercise (mmHg)

Secondary outcomes

  1. Blood Pressure Reactivity - Cold Pressor test

    Time frame: Day 10 of diet (i.e., after 10 days of low, medium, and high sodium diets; crossover design)

    Change in Blood pressure during a cold pressor test (mmHg)

  2. Sympathetic Responses - Handgrip exercise

    Time frame: Day 10 of diet (i.e., after 10 days of low, medium, and high sodium diets; crossover design)

    Sympathetic outflow (bursts per minute)

  3. Sympathetic Responses - Cold Pressor test

    Time frame: Day 10 of diet (i.e., after 10 days of low, medium, and high sodium diets; crossover design)

    Sympathetic outflow (bursts per minute)

Sponsors and collaborators

Lead sponsor

University of Delaware

Other

Registry information

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Aug 29, 2016
Registry last updated
Mar 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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