Vascular Effects of Acute Sodium (VEAS) Study

December 17, 2025 updated by: Austin Robinson, Indiana University

The Effects of a High Salt Meal on Blood Flow Regulation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators have previously used a high-sodium saline infusion to increase blood sodium and consequently increase blood pressure in Black and White individuals. The investigators' prior data suggest that increased blood sodium concentrations result in larger blood pressure elevations for a given elevation in blood sodium levels in Black compared to White adults. In this proposal, the investigators are seeking to translate these previous findings using a single high-salt meal (up to 2500 mg of sodium; similar to a few slices of pizza or a sandwich/burger and side dish). Our primary aims are to determine if the high-sodium meal causes greater 1) blood pressure dysregulation 2) decreases in blood vessel function and 3) larger changes in blood sodium in Black compared to White individuals. Other potential questions that could be determined include aging differences or an influence of fitness. The investigators will not exclude other races/ethnicities as the project will also determine the response of other minority groups (e.g. Asian or Latine/Hispanic adults) to a high-salt meal.

Participants will report to the laboratory for four visits. At the first visit, consent for study participation will be obtained and participants will be screened for eligibility. Baseline assessments will be completed which may include fitness testing and body composition assessments. If necessary, these assessments may be completed at a second in-person visit. Participants will then report to the laboratory for two experimental visits. At each visit, participants will consume a randomly assigned meal (i.e., a soup containing either low- or high-salt) and undergo assessments prior to and 30- and 60-minutes after consumption. During the study, all participants will consume both meals, however, the order of exposure will be randomly assigned.

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Auburn, Alabama, United States, 36849
        • Auburn University
    • Indiana
      • Bloomington, Indiana, United States, 47405
        • Indiana University School of Public Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Are between the ages of 19-40.
  2. Have blood pressure no higher than 140/90 mmHg.
  3. Have a BMI below 35 Kg/m2 (otherwise healthy)
  4. Free from metabolic disease (diabetes or renal disease), pulmonary disorders (e.g., COPD, severe asthma, or cystic fibrosis), and cardiovascular disease (peripheral vascular, cardiac, or cerebrovascular).
  5. Do not have any precluding medical issues that prevent participants from exercising (i.e., cardiovascular issues, or muscle/joint issues including painful arthritis) or giving blood (e.g., blood thinners).
  6. Are not currently smoking, using smokeless tobacco, nor smoked within the past 12 months.

Exclusion Criteria:

  1. High blood pressure - greater than 140/90 mmHg
  2. Obesity (BMI > 30 kg/m2)
  3. History of metabolic disease (diabetes or renal disease), pulmonary disorders (e.g., COPD, severe asthma, or cystic fibrosis), and cardiovascular disease (peripheral vascular, cardiac, or cerebrovascular)
  4. Medical issues that prevent safe exercise (i.e., cardiovascular issues, or muscle/joint issues including painful arthritis)
  5. Medical issues that prevent giving blood (e.g., blood thinners)
  6. Currently smoking, using smokeless tobacco, or vaping (within past 12 monrths)
  7. Current pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High Sodium Meal (2500 mg sodium), Then Low Sodium Meal (140 mg sodium)
On experimental visit days, participants will consume each of the experimental meals, in this order. Prior to, and at several timepoints after consumption, they will have sympathetic nerve activity, vascular function, blood pressure and blood samples (from intravenous catheters) assessed.
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.
Experimental: Low Sodium Meal (140 mg sodium), then High Sodium Meal (2500 mg sodium)
On experimental visit days, participants will consume each of the experimental meals, in this order. Prior to, and at several timepoints after consumption, they will have sympathetic nerve activity, vascular function, blood pressure and blood samples (from intravenous catheters) assessed.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in blood pressure reactivity
Time Frame: Before and one hour after soup, both conditions (high- and low- salt)
The investigators will measure systolic and diastolic pressure using photoplethysmography at the finger. Systolic and diastolic blood pressure will be assessed at rest and during handgrip exercise. Blood pressure reactivity will be expressed as a change in pressure (mmHg) from baseline to a predetermined time during the stressor (e.g., minute one average and minute two average).
Before and one hour after soup, both conditions (high- and low- salt)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in flow-mediated dilation (FMD)
Time Frame: Before, 30 minutes, and one hour after soup, both conditions (high- and low- salt)
Flow-mediated vasodilation will be assessed using continuous measures of brachial artery diameter and velocity via duplex Doppler ultrasound (Hitachi Arietta 70). The brachial artery will be imaged in the longitudinal plane proximal to the medial epicondyle using a high-frequency (6-12 MHz) linear-array probe. The ultrasound probe will be stabilized using a custom-built clamp. Shear rate (sec-1) will be calculated as [(blood flow velocity (cm*s-1) *4)/blood vessel diameter (mm)] The image will be recorded throughout a 60-s baseline, a 300-s ischemic stimulus (250 mmHg), and 180 seconds post deflation. FMD will be expressed as % dilation (final diameter-baseline diameter/baseline diameter x 100) and also normalized to the shear stimulus. Allometric scaling will be used if appropriate, including if there are baseline differences in artery diameter by race or condition.
Before, 30 minutes, and one hour after soup, both conditions (high- and low- salt)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in indices of arterial stiffness
Time Frame: Before 30 minutes, and one hour after soup, both conditions (high- and low- salt)
The investigators will use the SphygmoCor XCEL system to assess pulse wave analysis (PWA) and pulse wave velocity (PWV). A high-fidelity strain-gauge transducer is used to obtain the pressure waveform at the carotid and radial pulse. Distances from the carotid artery sampling site to the femoral artery (upper leg instrumented with a thigh cuff for oscillometric sphygmomanometry), and from the carotid artery to the suprasternal notch will be recorded. The investigators will also assess forward and reflective wave magnitudes. PWV will be expressed as cm/s and PWA will be expressed as % (calculated as augmentation pressure divided by the pulse pressure).
Before 30 minutes, and one hour after soup, both conditions (high- and low- salt)
Changes in blood biomarkers of nitric oxide bioavailability
Time Frame: Before, 30 minutes, and one hour after soup, both conditions (high- and low- salt)
The investigators will measure nitric oxide metabolites (nitrate and nitrite nanomolar concentration).
Before, 30 minutes, and one hour after soup, both conditions (high- and low- salt)
Changes in circulating reactive oxygen species
Time Frame: Before, 30 minutes, and one hour after soup, both conditions (high- and low- salt)
The investigators will use electron paramagnetic resonance to measure reactive oxygen species (spectra units) in whole blood samples treated with a spin probe.
Before, 30 minutes, and one hour after soup, both conditions (high- and low- salt)
Changes in plasma sodium
Time Frame: Before, 30 minutes, and one hour after soup, both conditions (high- and low- salt)
The investigators will measure plasma sodium levels.
Before, 30 minutes, and one hour after soup, both conditions (high- and low- salt)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
University of Delaware

Investigators

  • Principal Investigator: Austin T Robinson, PhD, Auburn University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 3, 2021

Primary Completion (Actual)

December 15, 2025

Study Completion (Actual)

December 15, 2025

Study Registration Dates

First Submitted

December 5, 2019

First Submitted That Met QC Criteria

January 24, 2020

First Posted (Actual)

January 28, 2020

Study Record Updates

Last Update Posted (Estimated)

December 19, 2025

Last Update Submitted That Met QC Criteria

December 17, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23319
  • K01HL147998 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data with all HIPAA identifiers removed may be shared in future collaborative efforts pending appropriate DMDA approvals

IPD Sharing Time Frame

One year after completion of trial, indefinitely

IPD Sharing Access Criteria

A formal plan identifying the intended use fo the data and proper completion of a DMDA and MTA (if needed) with Auburn University and the study PI.

IPD Sharing Supporting Information Type

  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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