Vascular Effects of Acute Sodium (VEAS) Study

Indiana University

Status: Enrolling

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

Treatments: Other: Acute Salt (sodium chloride)

Study type: Interventional

Funder types: Other

Identifiers

NCT04244604

23319

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 19 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Are between the ages of 19-75.
2. Have blood pressure no higher than 150/90 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 & 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 the 150/90 mmHg
2. Low blood pressure - less than 90/50 mmHg
3. History of cardiovascular disease
4. History of cancer
5. History of diabetes
6. History of kidney disease
7. Obesity (BMI > 30 kg/m2)
8. Smoking or tobacco use
9. Current pregnancy
10. Nursing mothers
11. Communication barriers

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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100 participants in 2 patient groups, including a placebo group

High Sodium Meal (2500 mg sodium)

Experimental group

Description:

Participants will have sympathetic nerve activity, vascular function, blood pressure and blood samples (from intravenous catheters) assessed before and after a high sodium meal (2500 mg sodium).

Treatment:

Other: Acute Salt (sodium chloride)

Low Sodium Meal (140 mg sodium)

Placebo Comparator group

Description:

Participants will have sympathetic nerve activity, vascular function, blood pressure and blood samples (from intravenous catheters) assessed before and after a low sodium meal (140 mg sodium) which will serve as the control condition to demonstrate whether or not observed changes are due to high sodium or occur irrespective of sodium in the postprandial state.

Treatment:

Other: Acute Salt (sodium chloride)