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

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