Taking people in CanadaNo phase

Tests soy protein foods and a digital diet program for blood pressure

Tests two soy protein diets with a app in adults with high blood pressure.

Key facts

Who runs it: University of Toronto
Where: Toronto, CanadaSee the site
Trial code: NCT06907862
Registry title: The SWITCH (Substitution of High With Low Ultra-processed Soy Protein Foods In a Guideline-based Diet inTervention for Cardiometabolic Health) Trial
Status: Recruiting
People taking part: 300 people, planned
Started: 6 Aug 2025
Expected to end: 30 Jun 2028
Type of study: Interventional, 3 groupsOne group gets an existing treatment, for comparison.
Treatments tested: Reference Treatment
Control
Active Treatment
Record updated: 4 May 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with obesity and high blood pressure, about half of them with type 2 diabetes. It tests a 12-week digital diet program with soy foods.

Age: 18 years or older
Sex: All sexes can join
Disease stage: Obesity and hypertension (systolic blood pressure 120-160 mmHg); about 50% have type 2 diabetes with HbA1c 6.5-9.0% (48–75 mmol/mol)
Earlier treatment: Must be on stable blood pressure, blood sugar, cholesterol or weight-loss medicines for at least 3 months; must not plan new weight loss during the trial
Biomarker or test result: HbA1c 6.5-9.0% (48–75 mmol/mol) for people with type 2 diabetes

Main reasons for not taking part

Stroke or heart attack in the last year
Type 1 diabetes or current insulin treatment
Weight change of 5% or more in under 6 months
Soy allergy or intolerance
Chronic kidney or liver disease, or serious stomach and bowel disorders

The registry criteria, word for word

Show all 23 criteriaShow less

Who can take part

Obesity (BMI and waist circumference using sex and ethnic-specific thresholds for obesity and significant abdominal adiposity)
adults (≥18years)
hypertension (SBP 120-160 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%

Who cannot take part

current treatment with insulin
bariatric or recent surgery (<6 months)
chronic or prescribed use of certain medications including prescription high dose NSAIDs, antacids, warfarin, medications affecting NO synthesis (i.e. sildenafil, organic nitrates, etc.)
Individuals with a history of major cardiovascular events in the last year (stroke or myocardial infarction)
type 1 diabetes diagnosis
eating disorders; substance abuse disorders
serious depression or psychiatric disorders
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
allergies/intolerances to soy; allergies/intolerances to tree nuts, peanuts and seeds (the combination of all 3)
acute or chronic infection (e.g. active HIV, TB, COVID-19, chronic inflammatory infections)
chronic inflammatory condition (such as rheumatoid arthritis)
recent weight loss or weight gain (≥5% over <6 months)
herb or supplement use that may affect primary outcome
alcohol use >3 drinks/day; participation in another trial
use of antibiotics within 3-months of the study start

Where in Canada

C. David Naylor BuildingToronto, CanadaContact: Laura Chiavaroli, PhDTaking people

About the trial

What the trial wants to find out

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:

Read full original descriptionShow less

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).

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

The 3 groups in the trial

enhanced digital dietary intervention (High-UPF soy protein foods)Existing treatment, for comparison
The Active Treatment is an enhanced digital dietary intervention with high-UPF soy-containing foods.
Treatment: Active Treatment
enhanced digital dietary intervention (Low-UPF soy protein foods)Existing treatment, for comparison
The Reference Treatment is an enhanced digital dietary intervention with low-UPF soy-containing foods
Treatment: Reference Treatment
Standard of carePlacebo, for comparison
usual care provided by their primary care physician and/or specialist
Treatment: Control