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

NCT06614543 | Not Yet Recruiting

• 1 other identifier: HS26095 (B2023:073)
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Weight Loss; Prediabetes; Diabetes

Keywords

Weight Loss Clinic; Meal Replacement

Outcome Measures

Primary Outcomes (1)

• Feasibility of incorporating the WI meal replacements into their weight loss clinic design.

  Feasibility will be demonstrated if the following five criteria are met: 1. 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. 2. 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. 3. Follow up of greater than 85% of participant outcomes. 4. Adherence to the meal replacement intervention calculated by consumption of greater than 75% dispensed products as documented in the Product Consumption Log 5. 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 Outcomes (7)

• Changes in Body Weight

  At Enrollment (Week 0) and End of Study (Week 16)

• Changes in Waist Circumference

  At Enrollment (Week 0) and End of Study (Week 16)

• Changes in BMI

  At Enrollment (Week 0) and End of Study (Week 16)

• Cardiovascular Assessment

  At Enrollment (Week 0) and End of Study (Week 16)

• Changes is Quality of Life

  At Enrollment (Week 0) and End of Study (Week 16)

Other Outcomes (21)

• Changes in Systolic Blood Pressure

  At Enrollment (Week 0) and End of Study (Week 16)

• Changes in Diastolic Blood Pressure

  At Enrollment (Week 0) and End of Study (Week 16)

• Changes in Heart Rate

  At Enrollment (Week 0) and End of Study (Week 16)

Study Arms (2)

The WLC program plus meal replacements

ACTIVE COMPARATOR

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

The WLC program only

NO INTERVENTION

Interventions

Meal Replacement DIETARY_SUPPLEMENT

These meal replacements provide plant-based protein, fibre and fatty acids that have been shown to have health benefits related to chronic disease.

The WLC program plus meal replacements

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manitoba: lead
• Seven Oaks Hospital Chronic Disease Innovation Centre: collaborator
• The Wellness Institute: collaborator
• Sustainable Canadian Agricultural Partnership: collaborator

Study Sites (1)

Seven Oaks Hospital Chronic Disease Innovation Centre

Winnipeg, Manitoba, R2V 3M3, Canada

Location

MeSH Terms

Conditions

Weight Loss; Prediabetic State; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Dr Dylan MacKay, PhD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathy Cherepak, BSc

CONTACT

204-631-3834; kcherepak@sogh.mb.ca

Dr Dylan MacKay, PhD

CONTACT

204-272-3119; Dylan.Mackay@umanitoba.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: September 26, 2024
• Study Start: September 1, 2025
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: June 4, 2025

Record last verified: 2025-05

Locations

CA (1)