Vascular Effects of Acute Sodium (VEAS) Study

Summary

This IRB will cover a current clinical trial (NCT04244604) that was started at Auburn University (AU IRB#19-390), the Principal Investigator's prior institution, and is supported by his NIH Career Development Award (NHLBI K01HL147998).

About nine out of ten Americans overconsume dietary salt. Compared to other racial groups, Black individuals are more prone to salt-sensitive hypertension and negative cardiovascular conditions associated with high salt intake. However, there is a critical need to determine the reasons behind and mechanisms that contribute to these racial disparities. Both acute (single meal) and chronic high-dietary sodium cause small but important increases in blood sodium concentration that are associated with altered blood pressure regulation and blood vessel dysfunction. However, racial differences in these measures have not been examined. This is important because Black individuals generally exhibit lower circulating concentrations of hormones (e.g., renin, aldosterone, angiotensin 2) that buffer changes in body sodium to regulate blood pressure, and this could make them more vulnerable to the negative effects of a high-sodium meal.

Therefore, the purpose of this study is to determine whether there are racial differences in blood pressure regulation and blood flow after a high-sodium meal. The investigators will assess blood pressure regulation, blood vessel stiffness, and the blood vessel's ability to dilate before and after a high-salt meal and a low-salt control meal (both meals are low-salt tomato soup with varied added salt). The investigators will also collect blood and urine to measure sodium and determine biochemical changes that may be contributing to racial differences in cardiovascular function.

Conditions

• Sodium Excess
• Racial Disparities
• Blood Pressure
• Cardiovascular Risk Factor

Interventions

OTHER

Low Sodium Meal (140 mg sodium chloride)

Varied amounts of salt (sodium chloride) will be added to a very low sodium soup to determine the effects of a single high sodium meal on measures of vascular function and autonomic regulation of blood pressure. The Low Sodium soup will serve as the control condition.

OTHER

High Sodium Meal (2500 mg sodium chloride)

Varied amounts of salt (sodium chloride) will be added to a very low sodium soup to determine the effects of a single high sodium meal on measures of vascular function and autonomic regulation of blood pressure. The Low Sodium soup will serve as the control condition.

Sponsors & Collaborators

• University of Delaware

  collaborator OTHER

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Indiana University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

19 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-05-03

Primary Completion

2025-12-15

Completion

2025-12-15

Countries

• United States

Study Locations