Clinical trial NCT03424993: Vascular Effects of Dietary Salt in Humans With Salt-Resistant Blood Pressure
Official title: Vascular Effects of Dietary Salt in Humans With Salt-Resistant Blood Pressure: Dietary Counseling Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Keywords: Endothelium, vascular
Cardiovascular Disease
Hemodynamics
Oxidative Stress
Dietary Sodium
Dietary Counseling
Lead sponsor: University of Delaware
Sponsor class: OTHER
First posted: 2018-02-07
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Reflected Pulse Wave Amplitude
timeFrame: Change from baseline at 4 weeks
Secondary outcomes:
measure: Microvascular Function
timeFrame: Change from baseline at 4 weeks
measure: Conduit Artery Endothelial Dependent Dilation
timeFrame: Change from baseline at 4 weeks
measure: Arterial Stiffness
timeFrame: Change from baseline at 4 weeks
measure: Forward pulse wave amplitude
timeFrame: Change from baseline at 4 weeks
Other outcomes:
Locations:
city: Newark
country: United States
facility: Department of Kinesiology and Applied Physiology, University of Delaware
state: Delaware
Study officials:
affiliation: University of Delaware
name: William B Farquhar, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Delaware
name: David G Edwards, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Delaware
name: Shannon Lennon, PhD
role: PRINCIPAL_INVESTIGATOR
References: