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

NCT06907862 | Recruiting

• 1 other identifier: REB #44955
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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:

• 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

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

Outcome Measures

Primary Outcomes (1)

• Systolic Blood Pressure

  Difference in mean change from baseline.

  from enrollment to the end of treatment at 12 weeks

Secondary Outcomes (14)

• Key Secondary Outcome: non-high-density lipoprotein cholesterol [non-HDL-C]

  from enrollment to the end of treatment at 12 weeks

• Body weight

  from enrollment to the end of treatment at 12 weeks

• Diastolic Blood Pressure

  from enrollment to the end of treatment at 12 weeks

• Blood Pressure Targets

  from enrollment to the end of treatment at 12 weeks

• Blood Lipids

  from enrollment to the end of treatment at 12 weeks

Other Outcomes (3)

• Exploratory mechanistic endpoint - DNA Methylation

  from enrollment to the end of treatment at 12 weeks

• Exploratory mechanistic endpoint - Telomere Length

  from enrollment to the end of treatment at 12 weeks

• Exploratory mechanistic endpoint - Intestinal Permeability

  from enrollment to the end of treatment at 12 weeks

Study Arms (3)

enhanced digital dietary intervention (High-UPF soy protein foods)

ACTIVE COMPARATOR

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

Other: Active Treatment

enhanced digital dietary intervention (Low-UPF soy protein foods)

ACTIVE COMPARATOR

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

Other: Reference Treatment

Standard of care

PLACEBO COMPARATOR

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

Other: Control

Interventions

Reference Treatment OTHER

≥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)

enhanced digital dietary intervention (Low-UPF soy protein foods)

Control OTHER

Usual care provided by their primary care physician and/or specialist.

Standard of care

Active Treatment OTHER

≥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)

enhanced digital dietary intervention (High-UPF soy protein foods)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Individuals with a history of major cardiovascular events in the last year (stroke or myocardial infarction)
• type 1 diabetes diagnosis
• recent weight loss or weight gain (≥5% 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 certain medications including prescription high dose 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)

Sponsors & Collaborators

• University of Toronto: lead

Study Sites (1)

C. David Naylor Building

Toronto, Ontario, L6A 1N9, Canada

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Dyslipidemias; Hypertension

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Lipid Metabolism Disorders; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Laura Chiavaroli, PhD

CONTACT

416-946-0579; switchtrial.nutrisci@utoronto.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The statistician will be blinded to the nature of the treatment when analyzing data (i.e., will not know the treatment assignment).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 2, 2025
• Study Start: August 6, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: IPD and supporting information will be available after the anticipated study completion date from June 2028 and will remain for 30 years until January 2058.
• Access Criteria: IPD data will be accessible though the University of Toronto Dataverse (https://borealisdata.ca/dataverse/toronto). The metadata record of our dataset will be public, however access to the data will be restricted. Users will need to request access using the contact information provided in order to view and download our restricted files.

Locations

CA (1)