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

Launched by UNIVERSITY OF TORONTO · Mar 26, 2025

Keywords

ClinConnect Summary

The SWITCH Trial is a research study designed to explore how different types of soy protein foods can affect heart health, particularly blood pressure, in adults who have high blood pressure and obesity, with many also living with type 2 diabetes. The trial will compare the effects of a digital dietary program that includes either high ultra-processed soy foods or low ultra-processed soy foods, alongside a recommended diet rich in fruits and vegetables, against standard care. The main goal is to see if the different soy foods have similar effects on lowering blood pressure and improving overall health over a 12-week period.

To participate in this study, individuals must be adults aged 18 and older with obesity and high blood pressure. They should also be on stable medications for these conditions and not planning to lose weight during the trial. Participants will have regular check-ins at the clinic, where they will have their blood pressure measured, provide samples, and review their food records. Those in the treatment groups will also need to consume specific soy products and follow the digital dietary program throughout the study. This is a great opportunity for those who want to contribute to research on dietary impacts on health while receiving guidance on improving their diet.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Obesity (BMI and waist circumference using sex and ethnic-specific thresholds for obesity and significant abdominal adiposity)
• • adults (≥18years)
• • hypertension (SBP 130-160 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 (≥5 kg 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 medications including prescription 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 such as rheumatoid arthritis)
• • use of antibiotics within 3-months of the study start