Feasibility Testing of Plant-Based Meal Replacement Products Made With Manitoba Crop Ingredients for Weight Loss and Diabetes Remission

The goal of this clinical trial is to advance the development of the WI meal replacements by evaluating the acceptance and feasibility of the meal replacements within the Wellness Institute's Weight Loss Clinic program (WLC). The main questions it aims to answer are:

• To determine whether the incorporation of WI meal replacements into their weight loss clinic design is feasible.
• To determine whether weight loss is supported by a plant-based meal replacement.
• To assess efficacy of the meal replacements by measuring changes in lifestyle behaviours and risk factors for chronic disease compared to non-meal replacement weight loss program members.
• To assess remission of diabetes and pre-diabetes.

Researchers will compare the WLC program plus meal replacements to the WLC program without the meal replacements to evaluate the implementation of the meal replacements into the WLC.

Participants will follow their WLC program for 16 weeks, and those in the intervention group will begin their meal replacements. Participants will have a choice on what type of meal replacement they will consume each day (either a bar or a shake) and will record this in the product consumption log.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetes; Weight Loss; Prediabetes
• Intervention / Treatment: Dietary supplement: Meal Replacement

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kathy Cherepak, BSc; Phone Number: 204-631-3834; Email: kcherepak@sogh.mb.ca
• Study Contact Backup: Name: Dr Dylan MacKay, PhD; Phone Number: 204-272-3119; Email: Dylan.Mackay@umanitoba.ca

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2V 3M3
      • Seven Oaks Hospital Chronic Disease Innovation Centre
      • Contact: Kathy Cherepak, BSc; Phone Number: 204-631-3834; Email: kcherepak@sogh.mb.ca
      • Sub-Investigator: Dr Rebecca Mollard, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or female, aged 18 years or above
• Live within the province of MB
• Ability to give written informed consent in English.
• Enrolled in the Wellness Institute Weight Loss Clinic

Exclusion Criteria:

• Female participant who is pregnant, lactating or planning pregnancy during the course of the program.
• Participants with known allergies to the meal replacement ingredients
• Has an active eating disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: The WLC program plus meal replacements; Participants will have a choice on what type of meal replacement they will consume each day (either a bar or a shake) and will record this in the product consumption log.	Dietary supplement: Meal Replacement; These meal replacements provide plant-based protein, fibre and fatty acids that have been shown to have health benefits related to chronic disease.
No Intervention: The WLC program only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of incorporating the WI meal replacements into their weight loss clinic design.	Feasibility will be demonstrated if the following five criteria are met: Eligibility to randomization ratio is greater than 0.5, calculated as the ratio of individuals within the WI WLC program who were randomized to the trial to the number eligible to participate who were approached to participate.; The percentage of participants who complete the 16-week program in the meal replacement arm is equivalent (plus or minus 10%) or greater than the standard arm.; Follow up of greater than 85% of participant outcomes.; Adherence to the meal replacement intervention calculated by consumption of greater than 75% dispensed products as documented in the Product Consumption Log; Product Acceptability using an Exit Questionnaire consisting of a 9-point hedonic box scale to assess mean acceptability values of 6 or greater (like at least slightly) in 75% or more of the participants.	At Enrollment (Week 0) and End of Study (Week 16)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Body Weight	Body weight will be measured in kg to the nearest 0.1 kg by an exercise professional.	At Enrollment (Week 0) and End of Study (Week 16)
Changes in Waist Circumference	Waist circumference in cm will be measured to the nearest 0.1 cm at the umbilicus, between the last rib and iliac crest using a fibreglass tape measured by an exercise professional.	At Enrollment (Week 0) and End of Study (Week 16)
Changes in BMI	Body Mass Index will be calculated using the formula BMI = kg/m2; where kg is the weight in kilograms and m2 is height in metres squared.	At Enrollment (Week 0) and End of Study (Week 16)
Cardiovascular Assessment	Using the Framingham Risk Score, cardiovascular risk will be calculated based on age, HDL-C, total cholesterol, systolic blood pressure, smoking status, and diabetes status to determine the participant's 10-year risk of cardiovascular disease and identification of metabolic syndrome.	At Enrollment (Week 0) and End of Study (Week 16)
Changes is Quality of Life	Quality of life will be measured through the SF-36 quality of life questionnaire. The SF-36 measures nine areas: physical functioning, role functioning (emotional), role functioning (physical), energy/fatigue, emotional well-being, social functioning, pain, general health, and health change. A higher score indicates greater levels of quality of life.	At Enrollment (Week 0) and End of Study (Week 16)
Changes in Medication	Changes in medications, dose, unit and frequency will be captured to assess remission of diabetes and pre-diabetes.	At Enrollment (Week 0) and End of Study (Week 16)
Changes in HemaglobinA1C	Changes in hemaglobinA1C will be used to assess remission of diabetes and pre-diabetes. Diagnostic Services of Manitoba will collect and process the participants blood samples and measure the hemoglobin A1C as a percentage according to their established protocols.	At Enrollment (Week 0) and End of Study (Week 16)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Systolic Blood Pressure	Systolic blood pressure in mmHg is measured in triplicate, on the non-dominant arm in a sitting position by an exercise professional using a validated oscillometric blood pressure monitor.	At Enrollment (Week 0) and End of Study (Week 16)
Changes in Diastolic Blood Pressure	Diastolic blood pressure in mmHg is measured in triplicate, on the non-dominant arm in a sitting position by an exercise professional using a validated oscillometric blood pressure monitor.	At Enrollment (Week 0) and End of Study (Week 16)
Changes in Heart Rate	Heart rate in beats per minute is measured in triplicate, on the non-dominant arm in a sitting position by an exercise professional using a validated oscillometric blood pressure monitor.	At Enrollment (Week 0) and End of Study (Week 16)
Changes in Physical Activity	Measured using the International Physical Activity Questionnaire - Short Form - (IPAQ-S)	At Enrollment (Week 0) and End of Study (Week 16)
Change in Physical Activity Behaviour Patterns	Assessed using total active minutes per day as measured by multi-directional accelerometry for 5 days. Participants will be asked to wear the accelerometer at all times.	At Enrollment (Week 0) and End of Study (Week 16)
Changes in Dietary Intake Behaviours	Dietary intake behaviours will be measured through The Mindful Eating Questionnaire. The Mindful Eating Questionnaire recognizing patterns of overeating or eating in response to stress, boredom, or other emotions. Scoring is based on five categories, which include Awareness (being aware of how food looks, tastes and smells); Distraction (focusing on other things while eating); Disinhibition (eating even when full); Emotional Response (eating in response to sadness or stress); and External Cues (eating in response to environmental cues, such as advertising)	At Enrollment (Week 0) and End of Study (Week 16)
Changes in Dietary Intake Behaviours	Changes in dietary intake behaviours will be measured through the Three Factor Eating Questionnaire which is comprised of 18 items, measuring uncontrolled eating, restrained eating and emotional eating. The higher the score represents more dependency to cognition, stress or emotion the eating patterns.	At Enrollment (Week 0) and End of Study (Week 16)
Changes in Dietary Intake - Number of Meals	Number of meals will be captured with a meal being defined as food intake greater than 500 kcal. Dietary intake will be captured using the RxFood app. RxFood is a type of AI-driven, image based dietary assessment tool that has already demonstrated clinical benefits in various adult and pediatric clinical settings and in research as a data collection tool. Strong correlation and strength of agreement have been illustrated between RxFood and nutrient estimates from Esha's Research Nutrition analysis software, which is an industry choice for nutritional analysis and regulatory compliance (Jefferson et al, 2020).	At Enrollment (Week 0) and End of Study (Week 16)
Changes in Dietary Intake - Number of Snacks	Number of snacks will be captured with a meal being defined as food intake less than 500 kcal. Dietary intake will be captured using the RxFood app. RxFood is a type of AI-driven, image based dietary assessment tool that has already demonstrated clinical benefits in various adult and pediatric clinical settings and in research as a data collection tool. Strong correlation and strength of agreement have been illustrated between RxFood and nutrient estimates from Esha's Research Nutrition analysis software, which is an industry choice for nutritional analysis and regulatory compliance (Jefferson et al, 2020).	At Enrollment (Week 0) and End of Study (Week 16)
Changes in Dietary Intake - Protein	Protein will be measured in grams and will be captured using the RxFood app. RxFood is a type of AI-driven, image based dietary assessment tool that has already demonstrated clinical benefits in various adult and pediatric clinical settings and in research as a data collection tool. Strong correlation and strength of agreement have been illustrated between RxFood and nutrient estimates from Esha's Research Nutrition analysis software, which is an industry choice for nutritional analysis and regulatory compliance (Jefferson et al, 2020).	At Enrollment (Week 0) and End of Study (Week 16)
Changes in Dietary Intake - Fat	Fat will be measured in grams and will be captured using the RxFood app. RxFood is a type of AI-driven, image based dietary assessment tool that has already demonstrated clinical benefits in various adult and pediatric clinical settings and in research as a data collection tool. Strong correlation and strength of agreement have been illustrated between RxFood and nutrient estimates from Esha's Research Nutrition analysis software, which is an industry choice for nutritional analysis and regulatory compliance (Jefferson et al, 2020).	At Enrollment (Week 0) and End of Study (Week 16)
Changes in Dietary Intake - Available Carbohydrates	Available carbohydrates will be measured in grams and will be captured using the RxFood app. RxFood is a type of AI-driven, image based dietary assessment tool that has already demonstrated clinical benefits in various adult and pediatric clinical settings and in research as a data collection tool. Strong correlation and strength of agreement have been illustrated between RxFood and nutrient estimates from Esha's Research Nutrition analysis software, which is an industry choice for nutritional analysis and regulatory compliance (Jefferson et al, 2020).	At Enrollment (Week 0) and End of Study (Week 16)
Changes in Dietary Intake - Fibre	Fibre will be measured in grams and will be captured using the RxFood app. RxFood is a type of AI-driven, image based dietary assessment tool that has already demonstrated clinical benefits in various adult and pediatric clinical settings and in research as a data collection tool. Strong correlation and strength of agreement have been illustrated between RxFood and nutrient estimates from Esha's Research Nutrition analysis software, which is an industry choice for nutritional analysis and regulatory compliance (Jefferson et al, 2020).	At Enrollment (Week 0) and End of Study (Week 16)
Changes in Sleep Patterns	An ActiGraph activity monitor will be used to measure sleep quality patterns for 5 days, with participants asked to wear the monitor at all times, including when they sleep.	At Enrollment (Week 0) and End of Study (Week 16)
Changes in Total Cholesterol	Diagnostic Services of Manitoba will collect and process the participants blood samples and measure the total cholesterol concentration in mmol/L according to their established protocols.	At Enrollment (Week 0) and End of Study (Week 16)
Changes in High density lipoprotein cholesterol	Diagnostic Services of Manitoba will collect and process the participants blood samples and measure the total cholesterol concentration in mmol/L according to their established protocols.	At Enrollment (Week 0) and End of Study (Week 16)
Changes in Low density lipoprotein cholesterol	Diagnostic Services of Manitoba will collect and process the participants blood samples and measure the total cholesterol concentration in mmol/L according to their established protocols.	At Enrollment (Week 0) and End of Study (Week 16)
Changes in Triglycerides	Diagnostic Services of Manitoba will collect and process the participants blood samples and measure the total cholesterol concentration in mmol/L according to their established protocols.	At Enrollment (Week 0) and End of Study (Week 16)
Changes in Total Cholesterol and High-Density Lipoprotein Cholesterol Ratio	Diagnostic Services of Manitoba will collect and process the participants blood samples and measure the total cholesterol concentration in mmol/L according to their established protocols.	At Enrollment (Week 0) and End of Study (Week 16)
Changes in Hemoglobin A1C	Diagnostic Services of Manitoba will collect and process the participants blood samples and measure the total cholesterol concentration in mmol/L according to their established protocols.	At Enrollment (Week 0) and End of Study (Week 16)
Changes in Dietary Intake - Energy	Energy will be measured in kCals and will be captured using the RxFood app. RxFood is a type of AI-driven, image based dietary assessment tool that has already demonstrated clinical benefits in various adult and pediatric clinical settings and in research as a data collection tool. Strong correlation and strength of agreement have been illustrated between RxFood and nutrient estimates from Esha's Research Nutrition analysis software, which is an industry choice for nutritional analysis and regulatory compliance (Jefferson et al, 2020).	At Enrollment (Week 0) and End of Study (Week 16)

Collaborators and Investigators

• Sponsor: University of Manitoba
• Collaborators: The Wellness Institute; Seven Oaks Hospital Chronic Disease Innovation Centre; Sustainable Canadian Agricultural Partnership
• Investigators: Principal Investigator: Dr Dylan MacKay, PhD, University of Manitoba

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2025
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: September 23, 2024
• First Submitted That Met QC Criteria: September 23, 2024
• First Posted (Actual): September 26, 2024

Study Record Updates

• Last Update Posted (Actual): June 4, 2025
• Last Update Submitted That Met QC Criteria: May 30, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Meal Replacement; Weight Loss Clinic
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Body Weight Changes; Glucose Metabolism Disorders; Weight Loss; Body Weight; Diabetes Mellitus
• Other Study ID Numbers: HS26095 (B2023:073)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No