Vascular Effects of Acute Sodium (VEAS) Study

NCT04244604 | Completed

• 2 other identifiers: 23319K01HL147998
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 2

Brief 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

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

Keywords

blood pressure; racial disparities; cardiovascular health; physical fitness; sleep; dietary sodium; dietary salt; diet

Outcome Measures

Primary Outcomes (1)

• Changes in blood pressure reactivity

  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 Outcomes (1)

• Changes in flow-mediated dilation (FMD)

  Before, 30 minutes, and one hour after soup, both conditions (high- and low- salt)

Other Outcomes (4)

• Changes in indices of arterial stiffness

  Before 30 minutes, and one hour after soup, both conditions (high- and low- salt)

• Changes in blood biomarkers of nitric oxide bioavailability

  Before, 30 minutes, and one hour after soup, both conditions (high- and low- salt)

• Changes in circulating reactive oxygen species

  Before, 30 minutes, and one hour after soup, both conditions (high- and low- salt)

Study Arms (2)

High Sodium Meal (2500 mg sodium), Then Low Sodium Meal (140 mg sodium)

EXPERIMENTAL

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); Other: High Sodium Meal (2500 mg sodium chloride)

Low Sodium Meal (140 mg sodium), then High Sodium Meal (2500 mg sodium)

EXPERIMENTAL

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); Other: High Sodium Meal (2500 mg sodium chloride)

Interventions

Low Sodium Meal (140 mg sodium chloride) OTHER

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.

High Sodium Meal (2500 mg sodium), Then Low Sodium Meal (140 mg sodium); Low Sodium Meal (140 mg sodium), then High Sodium Meal (2500 mg sodium)

High Sodium Meal (2500 mg sodium chloride) OTHER

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.

High Sodium Meal (2500 mg sodium), Then Low Sodium Meal (140 mg sodium); Low Sodium Meal (140 mg sodium), then High Sodium Meal (2500 mg sodium)

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are between the ages of 19-40.
• Have blood pressure no higher than 140/90 mmHg.
• Have a BMI below 35 Kg/m2 (otherwise healthy)
• 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).
• 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).
• Are not currently smoking, using smokeless tobacco, nor smoked within the past 12 months.

You may not qualify if:

• High blood pressure - greater than 140/90 mmHg
• Obesity (BMI \> 30 kg/m2)
• 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)
• Medical issues that prevent safe exercise (i.e., cardiovascular issues, or muscle/joint issues including painful arthritis)
• Medical issues that prevent giving blood (e.g., blood thinners)
• Currently smoking, using smokeless tobacco, or vaping (within past 12 monrths)
• Current pregnancy

Sponsors & Collaborators

• Indiana University: lead
• University of Delaware: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

Auburn University

Auburn, Alabama, 36849, United States

Location

Indiana University School of Public Health

Bloomington, Indiana, 47405, United States

Location

Related Publications (5)

• Wenner MM, Paul EP, Robinson AT, Rose WC, Farquhar WB. Acute NaCl Loading Reveals a Higher Blood Pressure for a Given Serum Sodium Level in African American Compared to Caucasian Adults. Front Physiol. 2018 Oct 1;9:1354. doi: 10.3389/fphys.2018.01354. eCollection 2018.

  PMID: 30327611 BACKGROUND

• Babcock MC, Robinson AT, Migdal KU, Watso JC, Wenner MM, Stocker SD, Farquhar WB. Reducing Dietary Sodium to 1000 mg per Day Reduces Neurovascular Transduction Without Stimulating Sympathetic Outflow. Hypertension. 2019 Mar;73(3):587-593. doi: 10.1161/HYPERTENSIONAHA.118.12074.

  PMID: 30661474 BACKGROUND

• Dickinson KM, Clifton PM, Burrell LM, Barrett PH, Keogh JB. Postprandial effects of a high salt meal on serum sodium, arterial stiffness, markers of nitric oxide production and markers of endothelial function. Atherosclerosis. 2014 Jan;232(1):211-6. doi: 10.1016/j.atherosclerosis.2013.10.032. Epub 2013 Nov 20.

  PMID: 24401240 BACKGROUND

• Migdal KU, Robinson AT, Watso JC, Babcock MC, Serrador JM, Farquhar WB. A high-salt meal does not augment blood pressure responses during maximal exercise. Appl Physiol Nutr Metab. 2020 Feb;45(2):123-128. doi: 10.1139/apnm-2019-0217. Epub 2019 Jun 25.

  PMID: 31238011 BACKGROUND

• Culver MN, Linder BA, Lyons DE, Hutchison ZJ, Garrett CL, McNeil JN, Robinson AT. Do not sleep on vitamin D: vitamin D is associated with sleep variability in apparently healthy adults. Am J Physiol Regul Integr Comp Physiol. 2025 Mar 1;328(3):R262-R273. doi: 10.1152/ajpregu.00168.2024. Epub 2025 Jan 28.

  PMID: 39873709 DERIVED

MeSH Terms

Conditions

Hypernatremia

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The experimenter will be blinded to what sodium condition the participant is in, and all data analysis will be conducted blinded to the condition as well.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The intervention is to provide subjects with either a low sodium meal (140 mg sodium) and a high sodium meal (2500 mg sodium), in a randomized order.

Study Record Dates

• First Submitted: December 5, 2019
• First Posted: January 28, 2020
• Study Start: May 3, 2021
• Primary Completion: December 15, 2025
• Study Completion: December 15, 2025
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF, ANALYTIC CODE
• Time Frame: One year after completion of trial, indefinitely
• 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.

Locations

US (2)