Examining the Individual Response to a Low-Sodium Diet in Patients with Hypertension: Protocol for a Pilot Randomized Controlled Trial

BACKGROUND: Excessive dietary sodium intake is an independent risk factor for hypertension and cardiovascular disease (CVD). Despite the large body of evidence concerning the effects of dietary interventions on blood pressure (BP) and CVD outcomes, trials have often reported low adherence to decreased sodium intake, likely due in part to heterogeneous BP responses. To address the challenges, recent clinical findings suggested a precise and personalized dietary approach that seeks to deliver more preventive and practical dietary advice than the “one-size-fits-all” guidelines and weighs the personal risk of developing specific diseases. OBJECTIVE: The purpose of this pilot randomized controlled trial was to test the feasibility and preliminary efficacy of integrating the use of mobile technology and metabolomics with a low-sodium diet intervention in patients with hypertension to develop personalized low-sodium diet programs. Additionally, the study will examine the associations of urine metabolites with urinary sodium levels and BP control based on the hypothesis that targeted urine metabolites. In this report, we describe the design and protocol of the pilot trial. METHODS: A total of 40 patients with hypertension will be randomly assigned to either a 8-week low-sodium diet group (n=20) or a standard care group (n=20). Each week, intervention participants went through individual sessions with an interventionist via videoconferencing to discuss low-sodium diet regimens, patients’ food choices, and BP tracks on mobile apps. The control group followed their usual care for hypertension management. All participants in both groups monitored diet and BP using mobile apps for 8 weeks. A 24-hour urinary sodium excretion for the estimation of dietary sodium intake, systolic, and diastolic BPs were measured at the baseline and at 8 weeks. The primary outcomes of this study include the feasibility of conducting a randomized controlled trial (RCT) by reporting recruitment, retention, and completion statistics. The preliminary effects of intervention will be tested by a generalized estimating equation model. RESULTS: This pilot RCT study was approved by the institutional review board at the University of Texas Health San Antonio in January 2021. The first participant was enrolled in April 2021, and currently, 26 participants were enrolled. All data collection is expected to conclude by March 2023, with data analysis and study results ready for reporting by December 2023. Findings from this pilot RCT will further guide the team in planning a future large-scale study. CONCLUSIONS: The findings of this proposed study will establish a comprehensive knowledge base for future research and development of personalized dietary interventions to promote adherence to dietary strategies and self-management of chronic disease using the Precision Health approach for millions of Americans who are struggling with uncontrolled hypertension. TRIAL REGISTRATION: ClinicalTrials.gov NCT04764253; https://clinicaltrials.gov/ct2/show/NCT04764253 INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/39058