Effects of Sodium Intake on Arterial Stiffness in Black Men and Women

Effects of Sodium Intake on Arterial Stiffness in Black Adults

The purpose of this study is to explore the influence of sodium intake on arterial stiffness in African American/Black adults.

Study Overview

• Status: Completed
• Conditions: Arterial Stiffness; Sodium Intake
• Intervention / Treatment: Behavioral: Low-sodium intake; Dietary supplement: High-sodium intake

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Marcos, Texas, United States, 78666
      • Texas State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
Cardio-ankle vascular index	Cardio-ankle vascular index will be assessed using simultaneous arm and ankle blood pressures, EKG, and phonocardiography	This measurement will take approximately 1 minute and will be completed twice.

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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Texas State University

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2022
• Primary Completion (Actual): December 1, 2023
• Study Completion (Actual): December 30, 2023

Study Registration Dates

• First Submitted: February 22, 2023
• First Submitted That Met QC Criteria: April 3, 2023
• First Posted (Actual): April 18, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 28, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 8663

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No