Examining the Individual Response to a Restricted Sodium Diet in Hypertensive Patients

  • End date
    Jun 9, 2023
  • participants needed
  • sponsor
    The University of Texas Health Science Center at San Antonio
Updated on 4 October 2022
cardiovascular disease
systolic blood pressure
self monitoring
blood pressure diastolic
diet, sodium-restricted


Excessive dietary sodium intake is an independent risk factor for hypertension and cardiovascular disease. A vast array of efforts have tried to reduce sodium consumption based on evidence indicating a public health benefit. Yet this benefit has been questioned, mainly based on studies showing variability in individual responses to a sodium-restricted diet (SRD). The effects of an SRD on blood pressure vary, and adherence to an SRD is not optimal. The original Sodium Watchers Program (R01NR012967) was developed and implemented by Dr. Misook Chung (University of Kentucky). In this pilot study, the modified Sodium Watchers Program will propose improving adherence to an SRD through education and digital self-monitoring for daily sodium intake and blood pressure.

In addition, few studies have examined individuals' metabolic responses to the SRD. In a secondary analysis, we further will examine genetic variants associated with salt sensitivity and whether such a genetic component is associated with sodium excretion and BP control.

A total of 40 hypertensive patients will be randomly assigned to the intervention (n=20) or control group (n=20). The intervention group will receive 8-week education sessions remotely using a video conferencing program. All participants will collect a 24-hour urine specimen for sodium excretion and a total of 4.0ml of peripheral blood will be drawn for salt sensitivity during baseline visit. All participants will be asked to log their activities in real-time, including food intake and in-home BP monitoring using Fitbit and accompanied mobile app and BP monitor.

Condition high blood pressure, Vascular Diseases, Elevated Blood Pressure, arterial hypertension, High Blood Pressure (Hypertension), Diabetes and Hypertension, Hypertension, High Blood Pressure (Hypertension - Pediatric)
Treatment Modified Sodium Watcher Program + Digital Self-Monitoring, Usual care + Digital Self-Monitoring
Clinical Study IdentifierNCT04764253
SponsorThe University of Texas Health Science Center at San Antonio
Last Modified on4 October 2022


Yes No Not Sure

Inclusion Criteria

Systolic blood pressure of 120-159 mmHg or diastolic blood pressure of 80-99 mmHg, whether or not taking blood pressure medications
Smartphone with a data plan
Valid email address
Willing and able to participate in online study videoconferencing visits (Zoom)
Reads and writes in English

Exclusion Criteria

Participating in another related research study
Cardiovascular disease event (e.g. stroke, myocardial infarction) in prior 6 months
Active cancer
Recent hospitalization due to psychiatric condition or event
Pregnancy or breastfeeding - current or planned during the study period
Documented dementia
Diabetes Diagnosis
Heart Failure Diagnosis
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