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

NCT ID: NCT05815043

Last Updated: 2025-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-13

Study Completion Date

2023-12-30

Brief Summary

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

Detailed Description

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Conditions

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Sodium Intake Arterial Stiffness

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Low- and high-sodium intake

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

Group Type EXPERIMENTAL

Low-sodium intake

Intervention Type BEHAVIORAL

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

High-sodium intake

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Low-sodium intake

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

Intervention Type BEHAVIORAL

High-sodium intake

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Texas State University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Texas State University

San Marcos, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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8663

Identifier Type: -

Identifier Source: org_study_id

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