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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-21

Study Completion Date

2024-06-10

Brief Summary

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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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Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Dietary Sodium Restriction

Daily habitual dietary sodium intake \< 2000mg

Group Type EXPERIMENTAL

Dietary Sodium Restriction

Intervention Type OTHER

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

Control

Routine habitual dietary sodium intake \>3400mg

Group Type SHAM_COMPARATOR

Control

Intervention Type 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.

Interventions

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Dietary Sodium Restriction

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

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes