Skip to content

Vascular Effects of Dietary Salt in Humans With Salt-Resistant Blood Pressure

Vascular Effects of Dietary Salt in Humans With Salt-Resistant Blood Pressure: Dietary Counseling Study

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03424993
Enrollment
100
Registered
2018-02-07
Start date
2018-01-21
Completion date
2024-06-10
Last updated
2024-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Endothelium, vascular, Cardiovascular Disease, Hemodynamics, Oxidative Stress, Dietary Sodium, Dietary Counseling

Brief summary

The purpose of this study is to determine the effects of dietary salt restriction on central hemodynamics and vascular function in men and women with salt resistant blood pressure.

Detailed description

Cardiovascular disease remains a major Public Health problem and is the leading cause of death in the US. Dietary sodium restriction is considered an important lifestyle modification for individuals with hypertension; however, there is controversy about the effects of dietary salt given that many individuals do not have salt sensitive blood pressure. Deleterious effects of salt on the vasculature may explain the finding that chronic DSR reduces the cardiovascular event rate by 25%despite only minor reductions in BP. It is not known whether dietary sodium restriction improves central pulsatile hemodynamics, known to be related to the development of left ventricular hypertrophy and heart failure risk, and whether the hypothesized improvements in central hemodynamics are similar in men & women. The purpose of this study is to determine the effects of dietary sodium restriction through dietary counseling on central hemodynamics and vascular function in men and women with salt resistant blood pressure.

Interventions

A registered dietician will counsel participants to reduce daily habitual dietary salt intake below 2000mg over 4 weeks

OTHERControl

Participants will consume their routine habitual dietary sodium intake \> 3400mg per day with regular pre determined check in phone calls from a registered dietician.

Sponsors

University of Delaware
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* Habitual dietary sodium intake \> 3400mg per day

Exclusion criteria

* Abnormal resting ECG * Current abnormal blood panel (assessed by comprehensive metabolic panel, lipid panel and complete blood count). * Hypertension (currently taking anti-hypertensive medications or resting blood pressure \>140/90 mmHg) * Medical history of cardiovascular disease, malignant cancer, diabetes or kidney disease * Obesity (Body Mass Index \> 30) * Current pregnancy * Unable to provide consent

Design outcomes

Primary

MeasureTime frameDescription
Reflected Pulse Wave AmplitudeChange from baseline at 4 weeksLate systolic pulsatile load on the left ventricle represented by reflected pulse wave amplitude; assessed by echocardiography combined with applanation tonometry.

Secondary

MeasureTime frameDescription
Microvascular FunctionChange from baseline at 4 weeksCutaneous microvascular dilatory response to local heating assessed by laser Doppler flowmetry coupled with intradermal microdialysis
Conduit Artery Endothelial Dependent DilationChange from baseline at 4 weeksBrachial artery flow mediated dilation assessed by duplex ultrasound
Arterial StiffnessChange from baseline at 4 weeksCarotid - Femoral pulse wave velocity assessed by applanation tonometry
Forward pulse wave amplitudeChange from baseline at 4 weeksCentral hemodynamic assessment of the forward pulse wave amplitude assessed by echocardiography combined with applanation tonometry.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026