Recruiting

Sodium Lowering

Sponsor:

Tulane University

Code:

NCT05388032

Conditions

Endothelial Dysfunction

Vascular Stiffness

Left Ventricular Hypertrophy

Left Ventricular Dysfunction

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Sodium Reduction Intervention

Study Details

Brief summary:

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.

Conditions

Endothelial Dysfunction

Vascular Stiffness

Left Ventricular Hypertrophy

Left Ventricular Dysfunction

Study ID

NCT05388032

Start date

Jan 25, 2023

Status verified date

Nov, 2024

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Men or women aged ≥40 years. Individuals <40 years are at a low risk for clinical and subclinical CVD
  • Elevated BP or hypertension (systolic BP ≥120 mmHg and diastolic BP ≥80 mmHg with or without use of antihypertensive medications)

Exclusion Criteria:

  • Glomerular filtration rate (eGFR) <30 or end-stage renal disease (kidney transplant or chronic dialysis)
  • History of cardiovascular disease
  • Shift worker or regularly work at night
  • Cancer requiring chemotherapy or radiation treatment in the previous two years
  • Current pregnancy or breastfeeding or plans to become pregnant during the study
  • Consumption of ≥21 alcoholic drinks/week
  • Current participation in another lifestyle intervention or drug trial
  • Current residence or planned residence that makes it difficult to meet trial requirements
  • Other concerns regarding ability to meet trial requirements (at the discretion of the study coordinator)

Study Design

Enrollment

256 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

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.

Interventions

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.

Primary outcome measure

  • Change in Left Ventricular Global Longitudinal Strain (LVGLS) from baseline to 12 months [ Time Frame: 12 months ]
  • Change in Left Ventricular Mass Index (LVMI) from baseline to 12 months [ Time Frame: 12 months ]
  • Change in Pulse Wave Velocity (PWV) from baseline to 12 months [ Time Frame: 12 months ]
  • Change in Flow-Mediated Dilation (FMD) from baseline to 12 months [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Marigny Bostock, MA, CHES

504-988-4391mbostock@tulane.edu

Locations

Tulane University Office of Health Research

Recruiting

New Orleans, Louisiana, United States, 70112

Contacts

Marigny J Bostock, MA, CHES

504-988-4391mbostock@tulane.edu

More Information

Sponsor

Tulane University

Last update posted

Nov 22, 2024

Last verified

Nov, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Tulane University on 2024-11-22.