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

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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Journal
Journal of the American Heart Association
Published
2026-10-30
DOI
https://doi.org/10.1161/jaha.126.049902
Primary Topic
Nutritional Studies and Diet
Type
article
Field-Weighted Citation Impact
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article

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, John L. Sievenpiper, Adam H. Metherel, Christopher D. Gardner et al.
1 links
Journal of the American Heart Association
Nutritional Studies and Diet
article

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

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.

Journal of the American Heart Association
St. Michael's Hospital (CA), Dalhousie University (CA), Harvard University (US), University of Toronto (CA), University of Saskatchewan (CA), Unity Health Toronto (CA), Stanford University (US), McMaster University (CA)
U.S. Department of Agriculture, Heart and Stroke Foundation of Canada, General Mills, Kellogg's, Danone, Almond Board of California, Dairy Farmers of Canada, United Soybean Board, Canadian Cardiovascular Society, Diabetes Canada, Canadian Nutrition Society, Alberta Pulse Growers Commission, Physicians Committee for Responsible Medicine, Institute for the Advancement of Food and Nutrition Sciences, University of Toronto, International Sweeteners Association, Canadian Institutes of Health Research, Obesity Canada
Good health and well-being, Zero hunger
Openalex Percentile: Top 10%
Nutritional Studies and Diet
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