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

University of Toronto

Status: Not yet enrolling

Conditions: Hypertension; Diabetes Mellitus Type 2; Metabolic Health; Dyslipidemia; Cardiovascular Risk Factors; Hypertension in Type 2 Diabetes

Treatments: Other: Active Treatment; Other: Control; Other: Reference Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT06907862

REB #44955

Details and patient eligibility

About

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

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 3 patient groups, including a placebo group

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

Active Comparator group

Description:

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

Treatment:

Other: Active Treatment

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

Active Comparator group

Description:

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

Treatment:

Other: Reference Treatment

Standard of care

Placebo Comparator group

Description:

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

Treatment:

Other: Control