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Soy showdown: processed vs. natural – which lowers blood pressure best?

NCT ID NCT06907862

Disease control Sponsor: University of Toronto Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This 12-week study tests whether replacing highly processed soy foods (like soy burgers) with less processed options (like tofu or edamame) can lower blood pressure and improve heart health in 300 adults with obesity, hypertension, and often type 2 diabetes. Participants use a digital app and get extra vegetables and fruit. The goal is to see if simple food swaps, combined with a guided diet program, work better than usual care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
soy protein foods (both highly processed and minimally processed) plus a vegetable and fruit blend
What this could lead to
If it works, this could show that simple food swaps—like choosing tofu over soy burgers—help manage blood pressure and heart health without extra medication.
What could go wrong
This is a 12-week diet study, not a drug trial, so results may be modest. Participants must follow strict daily food rules, which can be hard to stick with in real life.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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% 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 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) * chronic inflammatory condition (such as rheumatoid arthritis) * use of antibiotics within 3-months of the study start

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Conditions

The condition(s) this trial relates to.

Dyslipidemias hypertensive disorder inherited lipid metabolism disorder obesity disorder type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiovascular risk factors Diabetes mellitus type 2 Dyslipidemia Hypertension Hypertension in type 2 diabetes Metabolic health

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • C. David Naylor Building

    RECRUITING

    Toronto, Ontario, L6A 1N9, Canada

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