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The SWITCH (Substitution of High With Low Ultra-processed Soy Protein Foods In a Guideline-based Diet inTervention for Cardiometabolic Health) Trial

RecruitingNAAges 18 Years - anyAllUniversity of Toronto
NCT06907862 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This is a randomized, controlled, parallel study with 3 experimental arms aimed to assess the effect of a digital dietary intervention (web-based app, online behavior change curriculum) enhanced with 10 servings of vegetables and fruit (5 as dietary advice within the app, 5 within a dehydrated vegetable and fruit blend), with or without high Ultra Processed Food (UPF) soy-containing proteins compared to standard of care (usual care) on systolic blood pressure (SBP; primary outcome), and other key cardiometabolic endpoints over 12-weeks in adults living with hypertension and obesity, 50% with type 2 diabetes. The main questions this study aims to answer are: 1. Are nutrient-dense, high-UPF soy-protein foods similar (non-inferior) to low-UPF soy-protein foods in the context of a guidelines-based diet in their effect on blood pressure and other cardiometabolic risk factors? 2. Does an enha

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📋 Eligibility rules (as published)
Inclusion Criteria: * Obesity (BMI and waist circumference using sex and ethnic-specific thresholds for obesity and significant abdominal adiposity) * adults (≥18years) * hypertension (SBP 120-160 mmHg) * on stable antihypertensive, antihyperglycemic, antihyperlipidemic, or anti-obesity medications (≥3-months) * not planning new weight loss for the duration of the trial * 50% living with type 2 diabetes, HbA1c 6.5-9.0% Exclusion Criteria: * Individuals with a history of major cardiovascular events in the last year (stroke or myocardial infarction) * type 1 diabetes diagnosis * recent weight loss or weight gain (≥5% over \<6 months) * current treatment with insulin * eating disorders; substance abuse disorders * serious depression or psychiatric disorders * bariatric or recent surgery (\<6 months) * uncontrolled hypertension (SBP/DBP \>160/100 mmHg) * angina pectoris * gastrointestinal and malabsorption disorders (i.e. inflammatory bowel disease, celiac), pancreatitis, chronic kidney or liver disease, cardiac condition that compromises normal function (e.g. mitral valve disease, heart failure), major disability or disorder requiring continuous medical attention. * herb or supplement use that may affect primary outcome. * alcohol use \>3 drinks/day; participation in another trial. * allergies/intolerances to soy; allergies/intolerances to tree nuts, peanuts and seeds (the combination of all 3). * chronic or prescribed use of certain medications including prescription high dose NSAIDs, antacids, warfarin, medications affecting NO synthesis (i.e. sildenafil, organic nitrates, etc.) * acute or chronic infection (e.g. active HIV, TB, COVID-19, chronic inflammatory infections) * chronic inflammatory condition (such as rheumatoid arthritis) * use of antibiotics within 3-months of the study start
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What it tests

  • Reference Treatment
  • Control
  • Active Treatment
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Where

1 site
C. David Naylor Building
Toronto, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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