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

NANot yet recruitingINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

April 7, 2025

Primary Completion Date

June 30, 2027

Study Completion Date

June 30, 2028

Conditions
Hypertension in Type 2 DiabetesDiabetes Mellitus Type 2DyslipidemiaHypertensionMetabolic HealthCardiovascular Risk Factors
Interventions
OTHER

Reference Treatment

≥4 servings/day of soy products categorized as non-ultra processed according to the NOVA classification system (NOVA non-Group 4): ≥2 servings/day of a Group 1 soy milk and ≥1 serving/day of another Group 1 food, such as edamame or roasted soy nuts, and ≥1 serving/day of a Group 3 food, such as tofu or tempeh) as part of a digital dietary intervention, enhanced with 10 servings of vegetables and fruit (5 as dietary advice and 5 provided in a blend of dehydrated vegetables and fruit)

OTHER

Control

Usual care provided by their primary care physician and/or specialist.

OTHER

Active Treatment

≥4 servings/day of soy products categorized as ultra processed according to the NOVA classification system (NOVA Group 4): ≥2 servings/day of soy milk and ≥2 servings/day of other soy-based products such as soy yogurt, soy burgers, or soy ground round) as part of a digital dietary intervention, enhanced with 10 servings of vegetables and fruit (5 as dietary advice and 5 provided in a blend of dehydrated vegetables and fruit)

Trial Locations (1)

L6A 1N9

C. David Naylor Building, Toronto

All Listed Sponsors
lead

University of Toronto

OTHER