Clinical trial NCT04764253: Examining the Individual Response to a Restricted Sodium Diet in Hypertensive Patients
Official title: Examining the Individual Response to a Restricted Sodium Diet in Hypertensive Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2021-02-21
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in blood pressure over time
timeFrame: Up to 8 weeks
measure: Change in adherence to sodium restricted diet over time
timeFrame: Up to 8 weeks
Secondary outcomes:
measure: Adherence to dietary sodium intake monitoring
timeFrame: Up to 8 weeks
measure: Adherence to In-home BP monitoring
timeFrame: Up to 8 weeks
measure: Attendance at education sessions
timeFrame: Up to 8 weeks
measure: Retention rate
timeFrame: Up to 8 weeks
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: The University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at San Antonio
name: Jisook Ko, PhD
role: PRINCIPAL_INVESTIGATOR
References: