Vascular Effects of Dietary Salt in Humans With Salt-Resistant Blood Pressure: Dietary Counseling Study
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- University of Delaware
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Reflected Pulse Wave Amplitude
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 21 Years to 45 Years (Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
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
- Conduit Artery Endothelial Dependent Dilation(Change from baseline at 4 weeks)
- Microvascular Function(Change from baseline at 4 weeks)
- Arterial Stiffness(Change from baseline at 4 weeks)
- Forward pulse wave amplitude(Change from baseline at 4 weeks)
Investigators
William Farquhar
Professor
University of Delaware