A Comparison of Sodium-Induced Responses by Sex

Endothelial Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05815043
• Other study ID #: 8663
• Status: Recruiting
• Phase: N/A
• Start date: December 13, 2022
• Est. completion date: December 30, 2023

Study information

• Verified date: April 2023
• Source: Texas State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 30, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Endothelial Dysfunction
• Sodium Intake

Intervention

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.

Locations

Country	Name	City	State
United States	Texas State University	San Marcos	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hematocrit	Hematocrit will be determined from whole blood samples after each 3-day dietary condition.	This measurement will be obtained from the date of enrollment until the date of completion of the study up to 10 days after enrollment.
Primary	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.
Primary	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	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.