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

NCT ID: NCT06614543

Last Updated: 2025-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2026-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Weight Loss Prediabetes Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Meal Replacement

Intervention Type 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 only

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seven Oaks Hospital Chronic Disease Innovation Centre

NETWORK

Sponsor Role collaborator

The Wellness Institute

UNKNOWN

Sponsor Role collaborator

Sustainable Canadian Agricultural Partnership

UNKNOWN

Sponsor Role collaborator

University of Manitoba

OTHER

Sponsor Role lead

Responsible Party

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Dylan MacKay

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dr Dylan MacKay, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

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Seven Oaks Hospital Chronic Disease Innovation Centre

Winnipeg, Manitoba, Canada

Site Status

Countries

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Canada

Central Contacts

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Kathy Cherepak, BSc

Role: CONTACT

204-631-3834

Dr Dylan MacKay, PhD

Role: CONTACT

204-272-3119

Facility Contacts

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Kathy Cherepak, BSc

Role: primary

204-631-3834

Other Identifiers

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HS26095 (B2023:073)

Identifier Type: -

Identifier Source: org_study_id

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