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Hypertension in Type 2 DiabetesSWITCHNCT06907862

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

A study testing Reference Treatment and Active Treatment in people with Hypertension in Type 2 Diabetes and Diabetes Mellitus Type 2, run by University of Toronto at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Reference Treatment and Active Treatment
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
300 participants
Where
1 siteCanada
Study dates
6 Aug 2025to 30 Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 join

  • 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
Show all 17Show fewer
  • 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)
  • chronic inflammatory condition (such as rheumatoid arthritis)
  • use of antibiotics within 3-months of the study start

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Canada1 site, 1 recruiting
  • C. David Naylor Building

    Toronto, Ontario, L6A 1N9

    Laura Chiavaroli, PhD, 416-946-0579, switchtrial.nutrisci@utoronto.ca

    Sabrina Ayoub-Charette, PhD, 416-946-0579, switchtrial.nutrisci@utoronto.ca

    Recruiting

Other trials in Canada

About this study

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?
Read more

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
Being tested
Reference Treatment, Control, Active Treatment
Keywords
Randomized controlled trial, Hypertension, Cardiometabolic health, Ultra processed food, technology-based dietary intervention, dehydrated vegetable and fruit blend
Medical subject headings
Diabetes Mellitus, Type 2, Dyslipidemias, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Reference TreatmentOther

    ≥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)

  • ControlOther

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

  • Active TreatmentOther

    ≥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)

Study groups in NCT06907862
Study groupRoleWhat they receive
enhanced digital dietary intervention (High-UPF soy protein foods)Active comparatorThe Active Treatment is an enhanced digital dietary intervention with high-UPF soy-containing foods.
Receives: Other: Active Treatment
enhanced digital dietary intervention (Low-UPF soy protein foods)Active comparatorThe Reference Treatment is an enhanced digital dietary intervention with low-UPF soy-containing foods
Receives: Other: Reference Treatment
Standard of carePlacebo comparatorusual care provided by their primary care physician and/or specialist
Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Systolic Blood Pressure

    Difference in mean change from baseline.

    Measured: from enrollment to the end of treatment at 12 weeks

Secondary outcomes (14)
  1. Key Secondary Outcome: non-high-density lipoprotein cholesterol [non-HDL-C]

    Difference in mean change from baseline.

    Measured: from enrollment to the end of treatment at 12 weeks

  2. Body weight

    Difference in mean change from baseline.

    Measured: from enrollment to the end of treatment at 12 weeks

  3. Diastolic Blood Pressure

    Difference in mean change from baseline.

    Measured: from enrollment to the end of treatment at 12 weeks

  4. Blood Pressure Targets

    Difference in proportion achieving therapeutic targets for blood pressure (SBP<140mmHg and DBP <90mmHg for those without diabetes; SBP <130mmHg and DBP <80mmHg for those with diabetes; SBP <120mmHg for Hypertension Canada high-risk patients)

    Measured: from enrollment to the end of treatment at 12 weeks

  5. Blood Lipids

    Difference in mean change in low-density lipoprotein-cholesterol (LDL-C), triglycerides, and high-density lipoprotein-cholesterol (HDL-C) from baseline.

    Measured: from enrollment to the end of treatment at 12 weeks

  6. Blood Lipid Targets

    Difference in proportion achieving therapeutic targets for lipids (non-HDL-C <2.6mmol/L, LDL-C <2.0mmol/L)

    Measured: from enrollment to the end of treatment at 12 weeks

  7. Glycemic control

    Difference in mean change in HbA1c from baseline.

    Measured: from enrollment to the end of treatment at 12 weeks

  8. Glycemic control

    Difference in mean change in fasting glucose from baseline.

    Measured: from enrollment to the end of treatment at 12 weeks

  9. Insulin

    Difference in mean change in fasting insulin from baseline.

    Measured: from enrollment to the end of treatment at 12 weeks

  10. Insulin Resistance

    Difference in mean change in insulin resistance (HOMA-IR) from baseline.

    Measured: from enrollment to the end of treatment at 12 weeks

  11. Inflammation

    Difference in mean change in C-Reactive Protein (CRP) from baseline.

    Measured: from enrollment to the end of treatment at 12 weeks

  12. Body Composition

    Difference in mean change in body mass index from baseline.

    Measured: from enrollment to the end of treatment at 12 weeks

  13. Body Composition

    Difference in mean change in waist circumference from baseline.

    Measured: from enrollment to the end of treatment at 12 weeks

  14. Body Composition

    Difference in mean change in body fat from baseline.

    Measured: from enrollment to the end of treatment at 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2025
  2. Study start6 Aug 2025
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06907862
Sponsor's protocol ID
REB #44955
Acronym
SWITCH
Status last verified
Apr 2026
First submitted
26 Mar 2025
Last updated
4 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All outcomes listed will be shared in an anonymous/de-identified format.

Publications

  • Houshialsadat Z, Viscardi G, Rossi AG, Ayoub-Charette S, El Chaar D, McKay B, Symington A, Kavanagh ME, Erlich MN, de Souza RJ, Vallis M, Ramdath DD, Metherel AH, Hall K, Gardner CD, Jovanovski E, Verma S, Kendall CWC, Jenkins DJA, Vuksan V, Sievenpiper JL, Chiavaroli L. Rationale and Design of a Parallel Randomized Trial of a DASH-Enhanced Portfolio Diet With or Without Ultra-Processed Plant Proteins for Blood Pressure and Other Cardiometabolic Risk Factors in Adults With Hypertension and Obesity: The Substitution of High With Low Ultra-Processed Soy Protein Foods in a Guideline-Based Diet Intervention on Cardiometabolic Health Trial. J Am Heart Assoc. 2026 Oct 30:e049902. doi: 10.1161/JAHA.126.049902. Online ahead of print.

    PubMed 42960735

Questions about this trial

What is this clinical trial studying?

A study testing Reference Treatment and Active Treatment in people with Hypertension in Type 2 Diabetes and Diabetes Mellitus Type 2, run by University of Toronto at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Laura Chiavaroli, PhD (416-946-0579, switchtrial.nutrisci@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Systolic Blood Pressure (time frame: from enrollment to the end of treatment at 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06907862, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.

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