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OpenTrials
Completed

NCT Number: NCT05815043

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

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

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Key information

Conditions

Sodium Intake Arterial Stiffness

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Texas State University

San Marcos, Texas, 78666, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low-sodium intake

Behavioral

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

High-sodium intake

Dietary Supplement

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

Primary outcomes

  1. Cardio-ankle vascular index

    Time frame: 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

  2. Ambulatory blood pressure

    Time frame: 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 outcomes

  1. Renal sodium excretion

    Time frame: 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 outcomes

  1. Hematocrit

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Texas State University

Other

Registry information

Official study title

Effects of Sodium Intake on Arterial Stiffness in Black Adults

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 18, 2023
Registry last updated
Jan 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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