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

University of Delaware

Status and phase: Completed; Phase 4

Conditions: Healthy

Treatments: Other: Dietary Sodium Restriction; Other: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT03424993

1083986

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 21 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Dietary Sodium Restriction

Experimental group

Description:

Daily habitual dietary sodium intake \< 2000mg

Treatment:

Other: Dietary Sodium Restriction

Control

Sham Comparator group

Description:

Routine habitual dietary sodium intake \>3400mg

Treatment:

Other: Control