Status:
NOT_YET_RECRUITING
The SWITCH (Substitution of High With Low Ultra-processed Soy Protein Foods In a Guideline-based Diet inTervention for Cardiometabolic Health) Trial
Lead Sponsor:
University of Toronto
Conditions:
Hypertension in Type 2 Diabetes
Diabetes Mellitus Type 2
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2028
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06907862
Start Date
April 7 2025
End Date
June 30 2028
Last Update
April 2 2025
Active Locations (1)
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1
C. David Naylor Building
Toronto, Ontario, Canada, L6A 1N9