Soy Protein Foods for High Blood Pressure
(SWITCH Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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 anthropometric measurements taken.* Complete and review all questionnaires received via email one week prior* Review the 3-day food records completed using the Keenoa mobile app one week prior to clinic visit.Final Study Visit (Week 12): 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.Throughout the study, participants will be asked to continue their usual lifestyle and physical activity.Additional Requirements for Treatment Groups:Participants randomized to the active and reference treatment groups will also be required to:* Incorporate a study vegetable and fruit blend (provided) into their daily diet for the full 12 weeks* Consume soy products categorized as either high ultra processed soy foods at least 4 servings per day, including at least 2 servings of ultra processed soy milk and 2 servings of other soy-based products (e.g., soy yogurt, soy burgers, or soy ground round) or non-ultra processed soy foods at least 4 servings per day, including at least 2 servings of minimally processed soy milk, 1 serving of edamame or roasted soy nuts, and 1 serving of tofu or tempeh* Participate in the digital dietary intervention, which includes: a health app, 7-day Kickstart Package, weekly text message support, and a 7-session online interactive program designed based on behaviour change theory* Attend a virtual focus group at Week 4 and complete an online feedback questionnaire
Do I need to stop my current medications to join the trial?
The trial does not specify that you need to stop taking your current medications. However, you must be on stable medications for blood pressure, blood sugar, cholesterol, or weight for at least 3 months before joining. If you are taking certain medications like NSAIDs or warfarin, you may not be eligible to participate.
Is soy protein safe for humans?
How does the treatment 'Digital Dietary Intervention' using soy protein foods differ from other treatments for high blood pressure?
This treatment is unique because it uses soy protein foods, which have been shown to lower blood pressure by reducing both systolic and diastolic levels, especially in people with high blood pressure. Unlike traditional medications, this approach focuses on dietary changes, leveraging the natural benefits of soy protein and its components like isoflavones, which may also improve heart health by lowering cholesterol.16789
What data supports the effectiveness of the treatment Digital Dietary Intervention using soy protein foods for high blood pressure?
Are You a Good Fit for This Trial?
Adults with hypertension and obesity, half of whom may also have type 2 diabetes. Participants must be willing to attend clinic visits, follow a digital dietary intervention, consume specific soy products daily, provide samples, and complete questionnaires. Those unable or unwilling to comply with study requirements are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo a 12-week intervention with either high-UPF or low-UPF soy-containing enhanced digital dietary intervention or standard of care
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Digital Dietary Intervention
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Toronto
Lead Sponsor