A Mechanistic Trial of Dietary Sodium Reduction on Vascular Structure and Function
Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:
• 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)
Locations
United States
Louisiana
Tulane University Office of Health Research
RECRUITING
New Orleans
Contact Information
Primary
Marigny Bostock, MA, CHES
mbostock@tulane.edu
504-988-4391
Time Frame
Start Date: 2023-01-25
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 256
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Tulane University
Collaborators: Johns Hopkins University