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
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)
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
Parallel
Reference Treatment
Other intervention≥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)
Control
Other interventionUsual care provided by their primary care physician and/or specialist.
Active Treatment
Other intervention≥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)
Systolic Blood Pressure
Difference in mean change from baseline.
Key Secondary Outcome: non-high-density lipoprotein cholesterol [non-HDL-C]
Difference in mean change from baseline.
Body weight
Difference in mean change from baseline.
Diastolic Blood Pressure
Difference in mean change from baseline.
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)
Exploratory mechanistic endpoint - DNA Methylation
Difference in mean change from baseline in DNA methylation.
Exploratory mechanistic endpoint - Telomere Length
Difference in mean change from baseline in telomere length.
Exploratory mechanistic endpoint - Intestinal Permeability
Difference in mean change from baseline in intestinal permeability.
Click on the lead sponsor to view all of their trials.
