A Comparison of Sodium-Induced Responses by Sex

Study Overview
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Brief Summary
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The purpose of this study is to explore the influence of biological sex on sodium-induced blood pressure and vascular function responses to variations in sodium intake in African American/Black adults.

Official Title
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Influence of Sex on Sodium-Induced Cardiovascular Responses in African American Adults

Conditions
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Sodium Intake, Endothelial Dysfunction

Intervention / Treatment
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* Behavioral: Low-sodium intake
* Dietary Supplement: High-sodium intake


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: African American or Black Male or Female Exclusion Criteria: pregnancy or within 60 days postpartum having taken blood pressure (including diuretics beta-blockers, ACE inhibitors, angiotensin receptor blockers, and calcium channel blockers) or statin medications within the past 3 months infection (viral or other) within the past 4 weeks having adrenal or endocrine tumors (these could impact BP) renal disease defined as a glomerular filtration rate (GFR) of less than 60 prior myocardial infarction known coronary heart disease personal history of stroke heart failure cardiac arrhythmias recent chest pain or dyspnea current insulin dependence currently undergoing chemotherapy or radiation identifying as transgender (the focus of this trial is biological sex) seated systolic or diastolic blood pressure of more than 149 mm Hg or 99 mm Hg, respectively

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low- and high-sodium intake<br>Participants will consume two different quantities of sodium per day for 3 days each. | Behavioral: Low-sodium intake<br>* Participants will consume less than or equal to 720 milligrams of sodium per day for 3 days.<br>Dietary Supplement: High-sodium intake<br>* Participants will supplement their existing diets with 10 salt tablets daily for 3 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial function | Brachial artery flow-mediated dilation will be assessed after 15 minutes of supine rest. | This measurement will take approximately 15 minutes and will be obtained from the date of enrollment until the date of completion of the study up to 10 days after enrollment. | 
| Ambulatory blood pressure | 24-hour ambulatory blood pressure monitoring will be completed on day 3 of each dietary condition. | This measurement will take approximately 24 hours and will be obtained from the date of enrollment until the date of completion of the study up to 10 days after enrollment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal sodium excretion | 24-hour urine samples will be analyzed for sodium concentrations and sodium excretion will be determined. | This measurement will be obtained from the date of enrollment until the date of completion of the study up to 10 days after enrollment. |