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Completed

NCT Number: NCT03424993

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

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.

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Key information

Conditions

Healthy Cardiovascular Diseases

Age range

21 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Kinesiology and Applied Physiology, University of Delaware

Newark, Delaware, 19713, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Dietary sodium restriction

Other

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

Control

Other

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

Primary outcomes

  1. Reflected Pulse Wave Amplitude

    Time frame: 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 outcomes

  1. Microvascular Function

    Time frame: Change from baseline at 4 weeks

    Cutaneous microvascular dilatory response to local heating assessed by laser Doppler flowmetry coupled with intradermal microdialysis

  2. Conduit Artery Endothelial Dependent Dilation

    Time frame: Change from baseline at 4 weeks

    Brachial artery flow mediated dilation assessed by duplex ultrasound

  3. Arterial Stiffness

    Time frame: Change from baseline at 4 weeks

    Carotid - Femoral pulse wave velocity assessed by applanation tonometry

  4. Forward pulse wave amplitude

    Time frame: Change from baseline at 4 weeks

    Central hemodynamic assessment of the forward pulse wave amplitude assessed by echocardiography combined with applanation tonometry.

Sponsors and collaborators

Lead sponsor

University of Delaware

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Feb 7, 2018
Registry last updated
Oct 28, 2024

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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