| NCT ID | NCT05388032 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tulane University |
| Condition | Endothelial Dysfunction |
| Study Type | INTERVENTIONAL |
| Enrollment | 256 participants |
| Start Date | 2023-01-25 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 256 participants in total. It began in 2023-01-25 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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)
Contact & Investigator
Katherine T Mills, PhD
PRINCIPAL INVESTIGATOR
Tulane University
Frequently Asked Questions
Who can join the NCT05388032 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Endothelial Dysfunction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05388032 currently recruiting?
Yes, NCT05388032 is actively recruiting participants. Contact the research team at mbostock@tulane.edu for enrollment information.
Where is the NCT05388032 trial being conducted?
This trial is being conducted at New Orleans, United States.
Who is sponsoring the NCT05388032 clinical trial?
NCT05388032 is sponsored by Tulane University. The principal investigator is Katherine T Mills, PhD at Tulane University. The trial plans to enroll 256 participants.