Clinical trial NCT06907862: The SWITCH (Substitution of High With Low Ultra-processed Soy Protein Foods In a Guideline-based Diet inTervention for Cardiometabolic Health) Trial
Official title: The SWITCH (Substitution of High With Low Ultra-processed Soy Protein Foods In a Guideline-based Diet inTervention for Cardiometabolic Health) Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypertension in Type 2 Diabetes
Diabetes Mellitus Type 2
Dyslipidemia
Hypertension
Metabolic Health
Cardiovascular Risk Factors
Keywords: Randomized controlled trial
Hypertension
Cardiometabolic health
Ultra processed food
technology-based dietary intervention
dehydrated vegetable and fruit blend
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2025-04-02
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

* Obesity (BMI and waist circumference using sex and ethnic-specific thresholds for obesity and significant abdominal adiposity)
* adults (≥18years)
* hypertension (SBP 130-160 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%

Exclusion Criteria:

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

Primary outcomes:
measure: Systolic Blood Pressure
timeFrame: from enrollment to the end of treatment at 12 weeks
Secondary outcomes:
measure: Key Secondary Outcome: non-high-density lipoprotein cholesterol [non-HDL-C]
timeFrame: from enrollment to the end of treatment at 12 weeks
measure: Body weight
timeFrame: from enrollment to the end of treatment at 12 weeks
measure: Diastolic Blood Pressure
timeFrame: from enrollment to the end of treatment at 12 weeks
measure: Blood Pressure Targets
timeFrame: from enrollment to the end of treatment at 12 weeks
measure: Blood Lipids
timeFrame: from enrollment to the end of treatment at 12 weeks
measure: Blood Lipid Targets
timeFrame: from enrollment to the end of treatment at 12 weeks
measure: Glycemic control
timeFrame: from enrollment to the end of treatment at 12 weeks
measure: Glycemic control
timeFrame: from enrollment to the end of treatment at 12 weeks
measure: Insulin
timeFrame: from enrollment to the end of treatment at 12 weeks
measure: Insulin Resistance
timeFrame: from enrollment to the end of treatment at 12 weeks
measure: Inflammation
timeFrame: from enrollment to the end of treatment at 12 weeks
measure: Body Composition
timeFrame: from enrollment to the end of treatment at 12 weeks
measure: Body Composition
timeFrame: from enrollment to the end of treatment at 12 weeks
measure: Body Composition
timeFrame: from enrollment to the end of treatment at 12 weeks
Other outcomes:
measure: Exploratory mechanistic endpoint - DNA Methylation
timeFrame: from enrollment to the end of treatment at 12 weeks
measure: Exploratory mechanistic endpoint - Telomere Length
timeFrame: from enrollment to the end of treatment at 12 weeks
measure: Exploratory mechanistic endpoint - Intestinal Permeability
timeFrame: from enrollment to the end of treatment at 12 weeks
Locations:
city: Toronto
country: Canada
facility: C. David Naylor Building
state: Ontario
Study officials:
References: