Sodium Lowering Vascular Effects Trial

Part of paid clinical trials in New Orleans, Louisiana.

Sponsor
Tulane University
Study ID
NCT05388032
Status
Recruiting
Apply to this trial

Conditions

  • Endothelial Dysfunction
  • Left Ventricular Dysfunction
  • Left Ventricular Hypertrophy
  • Vascular Stiffness

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sodium Reduction Intervention — BEHAVIORAL
    The sodium reduction intervention is a dietician-led behavioral intervention consisting of two phases, first a 3-month intensive intervention phase, followed by a 9-month maintenance phase. The overall goal of the intervention is to reduce sodium intake to \<2,300 mg per day based on the most recent guideline from the National Academies of Medicine. Both phases will include individual and group behavioral modification counseling designed to facilitate a reduction in dietary sodium intake.

Study Details

The proposed mechanistic trial will test the effect of dietary sodium reduction on cardiac and vascular structure and function in those with elevated blood pressure or hypertension. Findings from this study will fill the knowledge gap on the underlying mechanisms of dietary sodium intake on cardiovascular disease risk in addition to blood pressure and could provide further evidence on sodium reduction for the prevention of cardiovascular disease.

Key Dates

Start date
Jan 25, 2023
Status verified
Nov 2024
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
256 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: sodium reduction intervention
    The sodium reduction intervention is a dietician-led behavioral intervention consisting of two phases, first a 3-month intensive intervention phase, followed by a 9-month maintenance phase. The overall goal of the intervention is to reduce sodium intake to \<2,300 mg per day based on the most recent guideline from the National Academies of Medicine. Both phases will include individual and group behavioral modification counseling designed to facilitate a reduction in dietary sodium intake.
  • No Intervention: Usual Diet
    Participants randomized to the usual diet group will receive standard care from their providers with no study intervention.

Primary Outcome Measure

Change in Left Ventricular Global Longitudinal Strain (LVGLS) from baseline to 12 months [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Tulane University Office of Health ResearchNew OrleansLouisiana70112
Marigny J Bostock, MA, CHES
[email protected]
504-988-4391

Find similar trials in New Orleans, LA

By research site
Tulane University Office of Health Research· New Orleans, LA

Related Studies