Adverse Neurogenic Actions of Dietary Salt

Blood Pressure Clinical Trial

Official title:

Adverse Neurogenic Actions of Dietary Salt

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02881515
• Other study ID #: 819183
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: November 22, 2022

Study information

• Verified date: March 2023
• Source: University of Delaware
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: November 22, 2022
• Est. primary completion date: November 22, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure

Intervention

Other:
• Low Sodium Diet
Ten days of low sodium diet
• Medium Sodium Diet
Ten days of a medium sodium diet
• High Sodium Diet
Ten days of a high sodium diet

Locations

Country	Name	City	State
United States	University of Delaware	Newark	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
University of Delaware

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Pressure Variability	Standard deviation of systolic blood pressure over 24 hours (mmHg)	Day 10 of diet (i.e., after 10 days of low, medium, and high sodium diets; crossover design)
Primary	Blood Pressure Reactivity - Handgrip exercise	Change in Blood pressure during handgrip exercise (mmHg)	Day 10 of diet (i.e., after 10 days of low, medium, and high sodium diets; crossover design)
Secondary	Blood Pressure Reactivity - Cold Pressor test	Change in Blood pressure during a cold pressor test (mmHg)	Day 10 of diet (i.e., after 10 days of low, medium, and high sodium diets; crossover design)
Secondary	Sympathetic Responses - Handgrip exercise	Sympathetic outflow (bursts per minute)	Day 10 of diet (i.e., after 10 days of low, medium, and high sodium diets; crossover design)
Secondary	Sympathetic Responses - Cold Pressor test	Sympathetic outflow (bursts per minute)	Day 10 of diet (i.e., after 10 days of low, medium, and high sodium diets; crossover design)