Sodium Lowering Vascular Effects Trial
A Mechanistic Trial of Dietary Sodium Reduction on Vascular Structure and Function
Tulane University
256 participants
Jan 25, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria2
- 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 Criteria9
- 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)
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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05388032