Vascular Effects of Acute Sodium (VEAS) Study
Completed · Not applicable
Conditions studied: Sodium Excess, Racial Disparities, Blood Pressure, Cardiovascular Risk Factor
In brief
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.
Key facts
- Study ID
- NCT04244604
- Run by
- Indiana University
- People needed
- 71
- Starts
- 2021-05-03
- Expected to finish
- 2025-12-15
- Last updated by the study team
- 2025-12-19
Who can join
Age: 19 and older, up to 75. Sex: any. Healthy volunteers: accepted.
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
Where it is running
- Auburn University — Auburn, Alabama, United States
- Indiana University School of Public Health — Bloomington, Indiana, United States
Full record on ClinicalTrials.gov
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