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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03424993
• Other study ID #: 1083986
• Status: Recruiting
• Phase: Phase 4
• Start date: January 21, 2018
• Est. completion date: March 2024

Study information

• Verified date: November 2023
• Source: University of Delaware
• Contact: William B Farquhar, PhD
• Phone: 302-831-6178
• Email: wbf[@]udel.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Dietary Sodium Restriction
A registered dietician will counsel participants to reduce daily habitual dietary salt intake below 2000mg over 4 weeks
• Control
Participants will consume their routine habitual dietary sodium intake > 3400mg per day with regular pre determined check in phone calls from a registered dietician.

Locations

Country	Name	City	State
United States	Department of Kinesiology and Applied Physiology, University of Delaware	Newark	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
University of Delaware

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reflected Pulse Wave Amplitude	Late systolic pulsatile load on the left ventricle represented by reflected pulse wave amplitude; assessed by echocardiography combined with applanation tonometry.	Change from baseline at 4 weeks
Secondary	Microvascular Function	Cutaneous microvascular dilatory response to local heating assessed by laser Doppler flowmetry coupled with intradermal microdialysis	Change from baseline at 4 weeks
Secondary	Conduit Artery Endothelial Dependent Dilation	Brachial artery flow mediated dilation assessed by duplex ultrasound	Change from baseline at 4 weeks
Secondary	Arterial Stiffness	Carotid - Femoral pulse wave velocity assessed by applanation tonometry	Change from baseline at 4 weeks
Secondary	Forward pulse wave amplitude	Central hemodynamic assessment of the forward pulse wave amplitude assessed by echocardiography combined with applanation tonometry.	Change from baseline at 4 weeks