A Comparison of Sodium-Induced Responses by Sex
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Low- and high-sodium intake Participants will consume two different quantities of sodium per day for 3 days each. |
Behavioral: Low-sodium intake
Participants will consume less than or equal to 720 milligrams of sodium per day for 3 days.
Dietary Supplement: High-sodium intake
Participants will supplement their existing diets with 10 salt tablets daily for 3 days.
|
Outcome Measures
Primary Outcome Measures
- Endothelial function [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.]
Brachial artery flow-mediated dilation will be assessed after 15 minutes of supine rest.
- Ambulatory blood pressure [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.]
24-hour ambulatory blood pressure monitoring will be completed on day 3 of each dietary condition.
Secondary Outcome Measures
- Renal sodium excretion [This measurement will be obtained from the date of enrollment until the date of completion of the study up to 10 days after enrollment.]
24-hour urine samples will be analyzed for sodium concentrations and sodium excretion will be determined.
Other Outcome Measures
- Hematocrit [This measurement will be obtained from the date of enrollment until the date of completion of the study up to 10 days after enrollment.]
Hematocrit will be determined from whole blood samples after each 3-day dietary condition.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
African American or Black
-
Male or Female
Exclusion Criteria:
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pregnancy or within 60 days postpartum
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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
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infection (viral or other) within the past 4 weeks
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having adrenal or endocrine tumors (these could impact BP)
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renal disease defined as a glomerular filtration rate (GFR) of less than 60
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prior myocardial infarction
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known coronary heart disease
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personal history of stroke
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heart failure
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cardiac arrhythmias
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recent chest pain or dyspnea
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current insulin dependence
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currently undergoing chemotherapy or radiation
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identifying as transgender (the focus of this trial is biological sex)
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seated systolic or diastolic blood pressure of more than 149 mm Hg or 99 mm Hg, respectively
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Texas State University | San Marcos | Texas | United States | 78666 |
Sponsors and Collaborators
- Texas State University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 8663