Effects of reducing dietary sodium on heart and blood vessel health
A Mechanistic Trial of Dietary Sodium Reduction on Vascular Structure and Function
This study tests if cutting down on salt in your diet can improve heart and blood vessel health for people with high blood pressure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 256 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Tulane University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (New Orleans, Louisiana) |
| Trial ID | NCT05388032 on ClinicalTrials.gov |
What this trial studies
This trial investigates how lowering dietary sodium intake affects cardiac and vascular structure and function in individuals with elevated blood pressure or hypertension. Participants will be assigned to a dietitian-led intervention aiming for a sodium intake of less than 2,300 mg per day. The study will measure various cardiovascular parameters, including left ventricular mass index and flow-mediated dilation, to understand the non-blood pressure mediated effects of sodium reduction. The goal is to provide insights into the relationship between sodium intake and cardiovascular disease risk.
Who should consider this trial
Good fit: Ideal candidates are men and women aged 40 and older with elevated blood pressure or hypertension.
Not a fit: Patients with severe kidney disease, a history of cardiovascular disease, or those currently pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to dietary recommendations that significantly reduce cardiovascular disease risk for patients with hypertension.
How similar studies have performed: While there is limited evidence from randomized controlled trials on the effects of sodium reduction, observational studies suggest potential benefits, indicating this approach is both relevant and necessary.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
New Orleans, Louisiana
- Tulane University Office of Health Research — New Orleans, Louisiana, United States (Recruiting)
Study contacts
- Principal investigator: Katherine T Mills, PhD — Tulane University
- Study coordinator: Marigny Bostock, MA, CHES
- Email: mbostock@tulane.edu
- Phone: 504-988-4391
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.