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Dietary Sodium Restriction for Salt Sensitivity

Phase 4
Waitlist Available
Led By David G Edwards, PhD
Research Sponsored by University of Delaware
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Must not have
Medical history of cardiovascular disease, malignant cancer, diabetes or kidney disease
Unable to provide consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline at 4 weeks
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial will study how reducing dietary salt affects blood pressure and vascular function in people who are sensitive to salt.

Who is the study for?
This trial is for men and women who typically eat more than 3400mg of sodium daily and have normal blood pressure that doesn't change much with salt intake. They must be able to consent, have a normal ECG, blood tests, not be on blood pressure meds or pregnant, not obese, and free from heart disease, cancer, diabetes or kidney issues.
What is being tested?
The study aims to see how eating less salt affects the body's central hemodynamics (how the heart pumps blood) and vascular function (how the blood vessels work). Participants will follow a low-sodium diet compared to their usual high intake.
What are the potential side effects?
Since this trial involves dietary changes rather than medication, side effects are minimal but may include temporary discomforts like cravings or feeling unsatisfied with less salty foods.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of heart disease, cancer, diabetes, or kidney problems.
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I am unable to give my consent.
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I have high blood pressure or am on medication for it.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline at 4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline at 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Reflected Pulse Wave Amplitude
Secondary study objectives
Arterial Stiffness
Conduit Artery Endothelial Dependent Dilation
Forward pulse wave amplitude
+1 more

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Dietary Sodium RestrictionExperimental Treatment1 Intervention
Daily habitual dietary sodium intake \< 2000mg
Group II: ControlPlacebo Group1 Intervention
Routine habitual dietary sodium intake \>3400mg

Find a Location

Who is running the clinical trial?

University of DelawareLead Sponsor
161 Previous Clinical Trials
25,542 Total Patients Enrolled
David G Edwards, PhDPrincipal InvestigatorUniversity of Delaware
3 Previous Clinical Trials
94 Total Patients Enrolled
William B Farquhar, PhDPrincipal InvestigatorUniversity of Delaware
4 Previous Clinical Trials
166 Total Patients Enrolled

Media Library

Dietary Sodium Restriction (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03424993 — Phase 4
Healthy Subjects Research Study Groups: Dietary Sodium Restriction, Control
Healthy Subjects Clinical Trial 2023: Dietary Sodium Restriction Highlights & Side Effects. Trial Name: NCT03424993 — Phase 4
Dietary Sodium Restriction (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03424993 — Phase 4
~13 spots leftby Nov 2025
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