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

Conditions studied

Hypertension in Type 2 Diabetes, Diabetes Mellitus Type 2, Dyslipidemia, Hypertension, Metabolic Health, Cardiovascular Risk Factors

About this study

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 10 servings of vegetables and fruit (5 as dietary advice within the app, 5 within a dehydrated vegetable and fruit blend), with or without high Ultra Processed Food (UPF) soy-containing proteins compared to standard of care (usual care) on systolic blood pressure (SBP; primary outcome), and other key cardiometabolic endpoints over 12-weeks in adults living with hypertension and obesity, 50% with type 2 diabetes. The main questions this study aims to answer are: 1. Are nutrient-dense, high-UPF soy-protein foods similar (non-inferior) to low-UPF soy-protein foods in the context of a guidelines-based diet in their effect on blood pressure and other cardiometabolic risk factors? 2. Does an enhanced digital dietary intervention lead to meaningful reductions in blood pressure and other cardiometabolic risk factors compared to standard of care? Participants who are eligible and consent to be part of this study will be randomized to one of the following groups: 1) Active treatment (high-UPF soy-containing enhanced digital dietary intervention), 2) Reference treatment (low-UPF soy-containing enhanced digital dietary intervention), or 3) Control (standard of care). Participant Requirements: During the 12-week intervention, all participants will be required to attend in-person clinic visits at baseline (week 0), week 8 and 12. Baseline Visit (Week 0): Participants will be asked to arrive in a fasted state (no food or beverages, except water, for 10-12 hours before the visit). * Undergo various assessments, including anthropometric measurements, office blood pressure readings, and blood sampling (via a capillary finger prick and blood sample taken by the study nurse). * Review the 7-day food records completed using the Keenoa mobile app one week prior to clinic visit. * Bring fecal and urine samples from home. * Complete and review all questionnaires received via email one week prior. Telephone Check-in (Week 1): One week after beginning the study, the study staff will call participants to check in on how participants are following the protocol and answer any questions. Mid-Study Visit (Week 8): Participants will be asked to arrive in a fasted state (no food or beverages, except water, for 10-12 hours before the visit). * Have their office blood pressure and…

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)

Primary outcomes

• Systolic Blood Pressure (from enrollment to the end of treatment at 12 weeks)

Eligibility information

Study locations

• C. David Naylor Building, Toronto, Ontario L6A 1N9 Canada