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

University of Manitoba

Status: Not yet enrolling

Conditions: Weight Loss; Prediabetes; Diabetes

Treatments: Dietary Supplement: Meal Replacement

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT06614543

HS26095 (B2023:073)

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

The WLC program plus meal replacements

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Meal Replacement

The WLC program only

No Intervention group