Soy Protein Foods for High Blood Pressure

(SWITCH Trial)

Overseen By Laura Chiavaroli, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Toronto

Must be taking: Antihypertensives, Antihyperglycemics

Must not be taking: Insulin, NSAIDs, Warfarin, others

Disqualifiers: Cardiovascular events, Type 1 diabetes, others

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different soy protein foods can help manage high blood pressure and improve heart health. It compares a digital diet plan (Digital Dietary Intervention) that includes either high or low processed soy foods to regular care. Participants will consume soy products and use a health app to track their diet and receive support. The study seeks adults with high blood pressure and obesity, and some may also have type 2 diabetes. As an unphased trial, this study offers a unique opportunity to contribute to research that could lead to innovative dietary solutions for managing high blood pressure.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that digital programs for improving diet, like those in this trial, can positively affect blood pressure, eating habits, and weight. Some studies even suggest these programs can lead to healthier outcomes, such as lower blood pressure and improved eating habits.

This trial uses two types of soy protein foods: high ultra-processed and low ultra-processed. Ultra-processed foods (UPF) often link to negative health effects, like a higher risk of heart disease, due to added sugars and unhealthy fats. However, not all ultra-processed foods are the same, and their effects can vary.

Low ultra-processed soy foods are less modified and generally considered healthier. Previous studies have not identified major safety concerns with these low ultra-processed soy foods.

Overall, the digital diet program is usually well-received, and the soy foods used in this trial are commonly consumed, suggesting they are generally safe. Participants should monitor how they feel and report any unusual symptoms to the study team. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for high blood pressure because they use a digital dietary intervention to incorporate soy protein foods. Unlike traditional treatments that often rely on medications like ACE inhibitors or beta-blockers, these interventions focus on enhancing diet with either high or low ultra-processed soy-containing foods. The unique aspect here is the use of a digital platform to guide dietary changes, potentially offering a more personalized and accessible approach to managing blood pressure. By focusing on diet, this method could reduce reliance on medication and promote overall heart health naturally.

What evidence suggests that this trial's treatments could be effective for high blood pressure?

Studies have shown that digital tools can effectively lower blood pressure and improve heart health when used to assist with diet. Research indicates that these tools are particularly beneficial when aligned with the DASH diet, which aims to reduce high blood pressure by lowering salt intake. Additionally, consuming soy protein foods has been linked to positive effects on blood pressure. In this trial, participants will receive an enhanced digital dietary intervention with either high-UPF or low-UPF soy protein foods to evaluate their effects on heart health. Although researchers are still studying the benefits of highly processed versus less processed soy foods, both types are believed to support better heart health. Early findings suggest that using these digital tools, along with consuming soy protein, can lead to significant health improvements for people with high blood pressure. ^{1 2 3 6 7}

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

Not planning new weight loss for the duration of the trial

Obesity (BMI and waist circumference using sex and ethnic-specific thresholds for obesity and significant abdominal adiposity)

50% living with type 2 diabetes, HbA1c 6.5-9.0%

Exclusion Criteria

Eating disorders; substance abuse disorders

Serious depression or psychiatric disorders

My blood pressure is not higher than 160/100 mmHg.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 12-week intervention with either high-UPF or low-UPF soy-containing enhanced digital dietary intervention or standard of care

12 weeks

3 visits (in-person at baseline, week 8, and week 12), 1 visit (virtual at week 4)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Digital Dietary Intervention

Trial Overview

The trial is testing if high ultra-processed soy-protein foods can match low ultra-processed ones in improving blood pressure and cardiometabolic health when included in a diet based on guidelines. It also examines the impact of an enhanced digital dietary intervention versus standard care over 12 weeks.

How Is the Trial Designed?

Group I: enhanced digital dietary intervention (High-UPF soy protein foods) Active Control 1 Intervention

The Active Treatment is an enhanced digital dietary intervention with high-UPF soy-containing foods.

Group II: enhanced digital dietary intervention (Low-UPF soy protein foods) Active Control 1 Intervention

The Reference Treatment is an enhanced digital dietary intervention with low-UPF soy-containing foods

Group III: Standard of care Placebo Group 1 Intervention

usual care provided by their primary care physician and/or specialist

Who Is Running the Clinical Trial?

University of Toronto

Lead Sponsor

Trials

739

Recruited

1,125,000+

Citations

1.

withpower.com

withpower.com/trial/soy-protein-foods-for-high-blood-pressure-eb3a2

Soy Protein Foods for High Blood Pressure (SWITCH Trial)

Trial Overview The trial is testing if high ultra-processed soy-protein foods can match low ultra-processed ones in improving blood pressure and cardiometabolic ...

2.

trial.medpath.com

trial.medpath.com/clinical-trial/39eeb2ac2fb7c8f4/nct06907862-soy-protein-diet-cardiometabolic-health

The SWITCH (Substitution of High With Low Ultra-processed ...

This is a randomized, controlled, parallel study with 3 experimental arms aimed to assess the effect of a digital dietary intervention ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12413951/

Digital-Based Nutrition Interventions Employing the Dietary ...

Conclusion: Technology-based DASH diet interventions yielded favorable health outcomes, particularly in reducing BP and dietary salt intake, as well as improved ...

4.

researchgate.net

researchgate.net/publication/361528756_Ultra-processed_Foods_Consumption_Increases_the_Risk_of_Hypertension_in_Adults_A_Systematic_Review_and_Meta-Analysis

Ultra-Processed Foods Consumption Increases the Risk of ...

Conclusion Our findings suggested that UPFs might have detrimental effects on the incidence of hypertension in general population. Although ...

5.

jdc.jefferson.edu

jdc.jefferson.edu/cgi/viewcontent.cgi?article=1132&context=nursfp

Digital-Based Nutrition Interventions Employing the Dietary ...

Conclusion: Technology-based DASH diet interventions yielded favorable health outcomes, particularly in reducing BP and dietary salt intake, as ...

6.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0899900725001182

Review Impact of ultra-processed foods on human health

UPF consumption is linked to chronic diseases and increased mortality rates. Gut dysbiosis, inflammation, and oxidative stress drive UPF-related DNA damage.

7.

thelancet.com

thelancet.com/journals/lanam/article/PIIS2667-193X(24)00186-8/fulltext

Ultra-processed foods and cardiovascular disease

These data suggest that UPF are not a homogeneous entity concerning their nutritional quality and role in cardiovascular risk. Typical UPF (e.g. ...