Examining the Individual Response to a Low Sodium Diet Intervention in Hypertensive Patients: Protocol for Pilot Randomized Controlled Trial (Preprint)

Abstract

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 (and CVD outcomes), trials have often reported low adherence to lower sodium intake, likely due in part to heterogeneous blood pressure responses. To address these challenges in dietary interventions, recent clinical findings have suggested a personalized dietary approach combining metabolomics, genetics, and digital health technologies for the prevention and treatment of chronic diseases including hypertension. Precision nutrition, also called personalized nutrition, seeks to deliver more preventive and practical dietary advice than ‘one-size-fits-all’ guidelines and weigh the personal risk of developing specific diseases. In addition, one important single‐nucleotide polymorphism that influences blood pressure in humans is the salt sensitivity (SS) factor. However, the evidence on how the SS variant influences urinary metabolite profiles and blood pressure control following a low sodium diet intervention among individuals with hypertension is currently lacking.

Therefore, the purpose of this randomized controlled trial is to pilot a 2-month low sodium diet program to improve urinary metabolite profiles and blood pressure control.

A total of 60 hypertensive patients will be randomized assigned to either a low sodium diet group (n=20) or standard care group (n=10) for 2 months. Outcomes of interest include post-intervention changes in targeted urinary metabolite profiles, urinary sodium excretion, and blood pressure.

This study is approved by the University of Texas Health Science Center at San Antonio Institutional Review Board (#HSC20200054H). To date, interventionist training is completed, and participant enrollment began in April 2021. Thus far, we recruited 21 participants and expect preliminary results to be available in fall 2022.

This study will provide essential evidence on which to base a future larger clinical trial and could eventually be translated into an approach to improve the health of millions of Americans with hypertension.

Clinicaltrials.gov NCT04764253