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New treatment option for Hypertension in Type 2 Diabetes
Official title The SWITCH (Substitution of High With Low Ultra-processed Soy Protein Foods In a Guideline-based Diet inTervention for Cardiometabolic Health) Trial
ClinicalTrials.gov ID: NCT06907862
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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
You likely can't join 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
See the full eligibility 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%
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.