Examining the Individual Response to a Restricted Sodium Diet in Hypertensive Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hypertension
- Sponsor
- The University of Texas Health Science Center at San Antonio
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Change in blood pressure over time
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
- •Prisoners
- •Diabetes Diagnosis
- •Heart Failure Diagnosis
Outcomes
Primary Outcomes
Change in blood pressure over time
Time Frame: Up to 8 weeks
Blood pressure (BP) will be measured using a Vital Signs Monitor 300 Series model (WelchAllyn, US). The midsection circumference of the dominant upper arm will be measured with a tape measure, and the proper sized cuff will be selected accordingly. Systolic and diastolic BP will be measured in the dominant arm twice with a 2-minute rest period between measures; two measures will be averaged.
Change in adherence to sodium restricted diet over time
Time Frame: Up to 8 weeks
Participants will complete a 24-hour urinary sodium excretion test at baseline and at 8 weeks after the intervention is completed. 24-hour urinary sodium excretion (mg excreted/day) will be tested by collecting all urine excreted over 24 hours. Participants are asked to note the time when they start in a written log, then discard the first urine after that time. They will then collect all urine excreted over the course of the next 24 hours, noting down the time and amount excreted each time in the written log. Urine is stored in a container and does not need refrigeration. 24-hour urine sodium samples will be analyzed by the Center for Renal Precision Medicine laboratory.
Secondary Outcomes
- Adherence to In-home BP monitoring(Up to 8 weeks)
- Adherence to dietary sodium intake monitoring(Up to 8 weeks)
- Attendance at education sessions(Up to 8 weeks)
- Retention rate(Up to 8 weeks)