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

Not Applicable

Completed

• Conditions: Sodium Intake; Arterial Stiffness
• Interventions: Behavioral: Low-sodium intake; Dietary Supplement: High-sodium intake

• Registration Number: NCT05815043
• Lead Sponsor: Texas State University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-13
• Study First Submitted: 2023-02-22
• Study First Submitted QC: 2023-04-03
• Study First Posted: 2023-04-18
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Low- and high-sodium intake	Low-sodium intake	Participants will consume two different quantities of sodium per day for 3 days each.
Low- and high-sodium intake	High-sodium intake	Participants will consume two different quantities of sodium per day for 3 days each.

Primary Outcome Measures

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

Name	Time	Method
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.

Trial Locations

Locations (1)

Texas State University; 🇺🇸 San Marcos, Texas, United States