DOI: 10.1161/jaha.126.049902 ISSN: 2047-9980

Rationale and Design of a Parallel Randomized Trial of a DASH‐Enhanced Portfolio Diet With or Without Ultra‐Processed Plant Proteins for Blood Pressure and Other Cardiometabolic Risk Factors in Adults With Hypertension and Obesity: The Substitution o

Zeinab Houshialsadat, Gabrielle Viscardi, Antonio G. Rossi, Sabrina Ayoub‐Charette, Dayana El Chaar, Brighid McKay, Amy Symington, Meaghan E. Kavanagh, Madeline N. Erlich, Russell J. de Souza, Michael Vallis, D. Dan Ramdath, Adam H. Metherel, Kevin Hall, Christopher D. Gardner, Elena Jovanovski, Subodh Verma, Cyril W. C. Kendall, David J. A. Jenkins, Vladimir Vuksan, John L. Sievenpiper, Laura Chiavaroli
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Background

Cardiovascular disease remains the leading cause of death and hospitalization globally. Clinical practice guidelines recommend various plant‐based dietary patterns that target specific cardiometabolic risk factors, including the Dietary Approach to Stop Hypertension (DASH) diet for blood pressure and the Portfolio diet for low‐density lipoprotein cholesterol. Combining key elements of these patterns may enhance cardiovascular disease risk reduction. However, many soy‐based products, a key Portfolio component, are classified as ultra‐processed foods (UPFs). This trial will answer 2 questions: (1) Does a DASH‐enhanced Portfolio diet result in clinically meaningful reductions in blood pressure compared with standard of care and (2) Is a high‐UPF noninferior to a low‐UPF soy protein‐containing DASH‐enhanced Portfolio diet for blood pressure reduction?

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–noninferiority trial. Three hundred adults with hypertension and obesity, including 50% with type 2 diabetes, will be randomized to a high‐UPF or low‐UPF soy protein‐containing DASH‐enhanced Portfolio diet or standard of care for 12 weeks. The primary outcome is systolic blood pressure. Key secondary outcomes are non–high‐density lipoprotein cholesterol and body weight. Other outcomes include cardiometabolic risk factors.

Conclusions

Findings will provide high‐quality evidence on the use of a DASH‐enhanced Portfolio diet and the role of nutrient‐dense soy foods classified as UPFs within the combination of the 2 guideline‐based dietary patterns to support dietary strategies for cardiometabolic risk reduction.

REGISTRATION

URL: https://clinicaltrials.gov/ ; Unique identifier: NCT06907862.

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