CompletedNot Applicable

Vascular Effects of Acute Sodium (VEAS) Study

United States71 participantsStarted 2021-05-03

Plain-language 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.

Who can participate

Age range

19 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This study specifically looked at sodium excess and blood pressure reactivity — given my own blood pressure history and diet, could findings from a study like this change how you'd advise me to manage my sodium intake?
2I noticed this trial included racial disparities as one of its focus areas — could my racial or ethnic background affect how my body responds to high sodium, and is that something we should factor into my cardiovascular risk management?
3Since this trial has already been completed, are there published results I could review, and do those results suggest anything relevant to how we should be monitoring my blood pressure reactivity?
4The trial studied 'acute' sodium effects, meaning short-term spikes — should I be paying attention to not just my overall daily sodium intake but also sudden high-sodium meals, and how would that change my care plan?
5Are there any ongoing studies or evidence-based guidelines that build on this type of sodium and vascular research that might be more directly applicable to my current treatment options?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Changes in blood pressure reactivity

Timeframe: Before and one hour after soup, both conditions (high- and low- salt)

Trial details

NCT IDNCT04244604

SponsorIndiana University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-15

View on ClinicalTrials.gov More Sodium Excess trials