Substituting high- with low-ultra-processed soy protein foods within a guideline-based diet for cardiometabolic health
The SWITCH (Substitution of High With Low Ultra-processed Soy Protein Foods In a Guideline-based Diet inTervention for Cardiometabolic Health) Trial
This study tests whether a 12-week digital diet program with extra fruits and vegetables, combined with either low- or high-ultra-processed soy protein foods, can lower systolic blood pressure in adults with hypertension and obesity, about half of whom have type 2 diabetes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Toronto Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06907862 on ClinicalTrials.gov |
What this trial studies
This randomized, parallel-design study enrolls adults with hypertension and obesity and randomizes them to one of three 12-week arms: a digital dietary intervention plus low-ultra-processed soy protein foods, the same intervention plus high-ultra-processed soy protein foods, or usual care. The digital program includes a web-based app, an online behavior-change curriculum, and guidance to consume 10 additional servings of vegetables and fruit (half provided as a dehydrated blend). The primary outcome is change in systolic blood pressure, with secondary cardiometabolic endpoints including lipids and glycemic measures; about 50% of participants will have type 2 diabetes. Participants must be on stable cardiometabolic medications and meet obesity and blood pressure entry criteria.
Who should consider this trial
Good fit: Ideal candidates are adults with obesity and systolic blood pressure between 120–160 mmHg who are on stable antihypertensive or related cardiometabolic medications and willing to use a web app and follow dietary guidance for 12 weeks.
Not a fit: People with type 1 diabetes, current insulin therapy, recent major cardiovascular events, uncontrolled hypertension, significant gastrointestinal/malabsorption disorders, recent major weight change or bariatric surgery, or serious psychiatric or substance use disorders are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, the approach could offer a scalable, technology-supported dietary option that meaningfully lowers blood pressure and improves cardiometabolic risk in people with hypertension and obesity.
How similar studies have performed: Previous trials show dietary patterns and increased fruit/vegetable intake and some digital diet programs can lower blood pressure, but direct comparisons of high- versus low-ultra-processed soy protein foods in this context are novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Toronto, Ontario
- C. David Naylor Building — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Laura Chiavaroli, PhD
- Email: switchtrial.nutrisci@utoronto.ca
- Phone: 416-946-0579
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.