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

NCT05815043 | Completed

• 1 other identifier: 8663
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sodium Intake; Arterial Stiffness

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (1)

• 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.

Other Outcomes (1)

• 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.

Study Arms (1)

Low- and high-sodium intake

EXPERIMENTAL

Participants will consume two different quantities of sodium per day for 3 days each.

Behavioral: Low-sodium intake; Dietary Supplement: High-sodium intake

Interventions

Low-sodium intake BEHAVIORAL

Participants will consume less than or equal to 720 milligrams of sodium per day for 3 days.

Low- and high-sodium intake

High-sodium intake DIETARY_SUPPLEMENT

Participants will supplement their existing diets with 10 salt tablets daily for 3 days.

Low- and high-sodium intake

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• African American or Black
• Male or Female

You may not qualify if:

• 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

Sponsors & Collaborators

• Texas State University: lead

Study Sites (1)

Texas State University

San Marcos, Texas, 78666, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: April 18, 2023
• Study Start: December 13, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 30, 2023
• Last Updated: January 31, 2025

Record last verified: 2025-01

Locations

US (1)