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

NCT06614543 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-06-04

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Seven Oaks Hospital Chronic Disease Innovation Centre

    collaborator NETWORK
  • The Wellness Institute

    collaborator UNKNOWN
  • Sustainable Canadian Agricultural Partnership

    collaborator UNKNOWN
  • University of Manitoba

    lead OTHER

Principal Investigators

  • Dr Dylan MacKay, PhD · University of Manitoba

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2026-03-31
Completion
2026-03-31

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06614543 on ClinicalTrials.gov