Vascular Effects of Dietary Salt in Humans With Salt-Resistant Blood Pressure
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 healthy
Started Jan 2018
Longer than P75 for phase_4 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 21, 2018
CompletedFirst Submitted
Initial submission to the registry
January 29, 2018
CompletedFirst Posted
Study publicly available on registry
February 7, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 10, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 10, 2024
CompletedOctober 28, 2024
October 1, 2024
6.4 years
January 29, 2018
October 24, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Microvascular Function
Change from baseline at 4 weeks
Conduit Artery Endothelial Dependent Dilation
Change from baseline at 4 weeks
Arterial Stiffness
Change from baseline at 4 weeks
Forward pulse wave amplitude
Change from baseline at 4 weeks
Study Arms (2)
Dietary Sodium Restriction
EXPERIMENTALDaily habitual dietary sodium intake \< 2000mg
Control
SHAM COMPARATORRoutine habitual dietary sodium intake \>3400mg
Interventions
A registered dietician will counsel participants to reduce daily habitual dietary salt intake below 2000mg over 4 weeks
Participants will consume their routine habitual dietary sodium intake \> 3400mg per day with regular pre determined check in phone calls from a registered dietician.
Eligibility Criteria
You may qualify if:
- Habitual dietary sodium intake \> 3400mg per day
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Kinesiology and Applied Physiology, University of Delaware
Newark, Delaware, 19713, United States
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
William B Farquhar, PhD
University of Delaware
- PRINCIPAL INVESTIGATOR
David G Edwards, PhD
University of Delaware
- PRINCIPAL INVESTIGATOR
Shannon Lennon, PhD
University of Delaware
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 29, 2018
First Posted
February 7, 2018
Study Start
January 21, 2018
Primary Completion
June 10, 2024
Study Completion
June 10, 2024
Last Updated
October 28, 2024
Record last verified: 2024-10