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

Phase 4

Completed

• Conditions: Healthy
• Interventions: Other: Control; Other: Dietary Sodium Restriction

• Registration Number: NCT03424993
• Lead Sponsor: University of Delaware

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.

Study Timeline

• Study Start: 2018-01-21
• Study First Submitted: 2018-01-29
• Study First Submitted QC: 2018-02-05
• Study First Posted: 2018-02-07
• Primary Completion: 2024-06-10
• Study Completion: 2024-06-10
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-24
• Last Update Posted: 2024-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	Routine habitual dietary sodium intake \>3400mg
Dietary Sodium Restriction	Dietary Sodium Restriction	Daily habitual dietary sodium intake \< 2000mg

Primary Outcome Measures

Name	Time	Method
Reflected Pulse Wave Amplitude	Change from baseline at 4 weeks	Late systolic pulsatile load on the left ventricle represented by reflected pulse wave amplitude; assessed by echocardiography combined with applanation tonometry.

Secondary Outcome Measures

Name	Time	Method
Conduit Artery Endothelial Dependent Dilation	Change from baseline at 4 weeks	Brachial artery flow mediated dilation assessed by duplex ultrasound
Microvascular Function	Change from baseline at 4 weeks	Cutaneous microvascular dilatory response to local heating assessed by laser Doppler flowmetry coupled with intradermal microdialysis
Arterial Stiffness	Change from baseline at 4 weeks	Carotid - Femoral pulse wave velocity assessed by applanation tonometry
Forward pulse wave amplitude	Change from baseline at 4 weeks	Central hemodynamic assessment of the forward pulse wave amplitude assessed by echocardiography combined with applanation tonometry.

Trial Locations

Locations (1)

Department of Kinesiology and Applied Physiology, University of Delaware; 🇺🇸 Newark, Delaware, United States