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 of High With Low Ultra‐Processed Soy Protein Foods in a Guideline‐Based Diet Intervention on Cardiometabolic Health Trial
8 affiliations
- 1University of Toronto
- 2St. Michael's Hospital, Unity Health Toronto
- 3Harvard T.H. Chan School of Public Health
- 4McMaster University
- 5Dalhousie University
- 6University of Saskatchewan
- 7Independent Researcher
- 8Stanford University
Abstract
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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BibTeX
@article{houshialsadat2026rationale,
title = {{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 of High With Low Ultra‐Processed Soy Protein Foods in a Guideline‐Based Diet Intervention on Cardiometabolic Health Trial}},
author = {Zeinab Houshialsadat and Gabrielle Viscardi and Antonio G. Rossi and Sabrina Ayoub‐Charette and Dayana El Chaar and Brighid McKay and Amy Symington and Meaghan E. Kavanagh and Madeline N. Erlich and Russell J. de Souza and Michael Vallis and D. Dan Ramdath and Adam H. Metherel and Kevin Hall and Christopher D. Gardner and Elena Jovanovski and Subodh Verma and Cyril W. C. Kendall and David J. A. Jenkins and Vladimir Vuksan and John L. Sievenpiper and Laura Chiavaroli},
journal = {Journal of the American Heart Association},
year = {2026},
month = oct,
doi = {10.1161/jaha.126.049902},
url = {https://www.ahajournals.org/doi/10.1161/JAHA.126.049902},
note = {CC BY},
}
RIS
TY - JOUR
TI - 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 of High With Low Ultra‐Processed Soy Protein Foods in a Guideline‐Based Diet Intervention on Cardiometabolic Health Trial
AU - Zeinab Houshialsadat
AU - Gabrielle Viscardi
AU - Antonio G. Rossi
AU - Sabrina Ayoub‐Charette
AU - Dayana El Chaar
AU - Brighid McKay
AU - Amy Symington
AU - Meaghan E. Kavanagh
AU - Madeline N. Erlich
AU - Russell J. de Souza
AU - Michael Vallis
AU - D. Dan Ramdath
AU - Adam H. Metherel
AU - Kevin Hall
AU - Christopher D. Gardner
AU - Elena Jovanovski
AU - Subodh Verma
AU - Cyril W. C. Kendall
AU - David J. A. Jenkins
AU - Vladimir Vuksan
AU - John L. Sievenpiper
AU - Laura Chiavaroli
PY - 2026
DA - 2026/10/30
JO - Journal of the American Heart Association
DO - 10.1161/jaha.126.049902
UR - https://www.ahajournals.org/doi/10.1161/JAHA.126.049902
AB - 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.
SN - 2047-9980
ER -