(P42-13-26) Protocol of a Randomized Trial of a Guidelines-Based Diet With or Without Ultra-Processed Plant Proteins for Blood Pressure and Other Risk Factors in Adults With Hypertension

Objectives: Ultra-processed foods (UPFs) are seen as a key driver of obesity and its downstream complications. Despite soy-protein foods being a high-quality, nutrient-dense source of plant proteins in plant-based dietary patterns recommended in clinical practice guidelines for hypertension, obesity, diabetes and cardiovascular disease, the classification of most soy-protein foods on the market as UPFs put them at a nutritional “cross-roads”. Systolic blood pressure (SBP) is a major outcome tied to UPF intake in observational studies and the single most important risk factor as the #1 contributor to global morbidity and mortality. Recent guidelines call for high-quality studies to understand the role of nutrient-dense soy-protein UPFs within recommended dietary patterns. Our objective is to determine if a high-UPF soy protein-containing guidelines-based diet is non-inferior to a low-UPF soy protein-containing guidelines-based diet in replacing standard of care for SBP reduction and other UPF-related cardiometabolic risk factors.

Methods: The SWITCH (Substitution of high With low ultra-processed soy protein foods In a guideline-based diet inTervention for Cardiometabolic Health) trial is a parallel, randomized, 3-arm, open-label, superiority-non-inferiority trial. 300 adults with hypertension and obesity, and 50% with type 2 diabetes, will be randomized to a high- or low-UPF soy protein-containing DASH-enhanced Portfolio Diet Program (PortfolioDiet.app, online behavior curriculum, plus 10 servings of vegetables and fruit) or standard of care for 12 weeks. The high- and low-UPF arms will consume ≥4 servings (≥40g soy protein)/day of NOVA Group 4 soy products and NOVA Group 1 and 3 soy products, respectively. The primary outcome is SBP. Key secondary outcomes are non-high-density lipoprotein cholesterol (non-HDL-C) and body weight. Other outcomes include cardiometabolic risk factors. (Clinicaltrials.gov NCT06907862)

Results: N/A

Conclusions: Findings will provide high-quality evidence on the role of nutrient-dense soy foods classified as UPFs within the combination of two guideline-based dietary patterns to support dietary strategies for cardiometabolic risk reduction.

Funding Sources: Heart and Stroke Foundation of Canada & SNI Global through the United Soybean Board, a USDA “Check-off” Program