Clinical trial NCT06614543: Feasibility Testing of Plant-Based Meal Replacement Products Made With Manitoba Crop Ingredients for Weight Loss and Diabetes Remission
Official title: Feasibility Testing of Plant-Based Meal Replacement Products Made With Manitoba Crop Ingredients for Weight Loss and Diabetes Remission
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Weight Loss
Prediabetes
Diabetes
Keywords: Weight Loss Clinic
Meal Replacement
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Seven Oaks Hospital Chronic Disease Innovation Centre
name: The Wellness Institute
name: Sustainable Canadian Agricultural Partnership
First posted: 2024-09-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of incorporating the WI meal replacements into their weight loss clinic design.
timeFrame: At Enrollment (Week 0) and End of Study (Week 16)
Secondary outcomes:
measure: Changes in Body Weight
timeFrame: At Enrollment (Week 0) and End of Study (Week 16)
measure: Changes in Waist Circumference
timeFrame: At Enrollment (Week 0) and End of Study (Week 16)
measure: Changes in BMI
timeFrame: At Enrollment (Week 0) and End of Study (Week 16)
measure: Cardiovascular Assessment
timeFrame: At Enrollment (Week 0) and End of Study (Week 16)
measure: Changes is Quality of Life
timeFrame: At Enrollment (Week 0) and End of Study (Week 16)
measure: Changes in Medication
timeFrame: At Enrollment (Week 0) and End of Study (Week 16)
measure: Changes in HemaglobinA1C
timeFrame: At Enrollment (Week 0) and End of Study (Week 16)
Other outcomes:
measure: Changes in Systolic Blood Pressure
timeFrame: At Enrollment (Week 0) and End of Study (Week 16)
measure: Changes in Diastolic Blood Pressure
timeFrame: At Enrollment (Week 0) and End of Study (Week 16)
measure: Changes in Heart Rate
timeFrame: At Enrollment (Week 0) and End of Study (Week 16)
measure: Changes in Physical Activity
timeFrame: At Enrollment (Week 0) and End of Study (Week 16)
measure: Change in Physical Activity Behaviour Patterns
timeFrame: At Enrollment (Week 0) and End of Study (Week 16)
measure: Changes in Dietary Intake Behaviours
timeFrame: At Enrollment (Week 0) and End of Study (Week 16)
measure: Changes in Dietary Intake Behaviours
timeFrame: At Enrollment (Week 0) and End of Study (Week 16)
measure: Changes in Dietary Intake - Number of Meals
timeFrame: At Enrollment (Week 0) and End of Study (Week 16)
measure: Changes in Dietary Intake - Number of Snacks
timeFrame: At Enrollment (Week 0) and End of Study (Week 16)
measure: Changes in Dietary Intake - Energy
timeFrame: At Enrollment (Week 0) and End of Study (Week 16)
measure: Changes in Dietary Intake - Protein
timeFrame: At Enrollment (Week 0) and End of Study (Week 16)
measure: Changes in Dietary Intake - Fat
timeFrame: At Enrollment (Week 0) and End of Study (Week 16)
measure: Changes in Dietary Intake - Available Carbohydrates
timeFrame: At Enrollment (Week 0) and End of Study (Week 16)
measure: Changes in Dietary Intake - Fibre
timeFrame: At Enrollment (Week 0) and End of Study (Week 16)
measure: Changes in Sleep Patterns
timeFrame: At Enrollment (Week 0) and End of Study (Week 16)
measure: Changes in Total Cholesterol
timeFrame: At Enrollment (Week 0) and End of Study (Week 16)
measure: Changes in High density lipoprotein cholesterol
timeFrame: At Enrollment (Week 0) and End of Study (Week 16)
measure: Changes in Low density lipoprotein cholesterol
timeFrame: At Enrollment (Week 0) and End of Study (Week 16)
measure: Changes in Triglycerides
timeFrame: At Enrollment (Week 0) and End of Study (Week 16)
measure: Changes in Total Cholesterol and High-Density Lipoprotein Cholesterol Ratio
timeFrame: At Enrollment (Week 0) and End of Study (Week 16)
measure: Changes in Hemoglobin A1C
timeFrame: At Enrollment (Week 0) and End of Study (Week 16)
Locations:
city: Winnipeg
country: Canada
facility: Seven Oaks Hospital Chronic Disease Innovation Centre
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Dr Dylan MacKay, PhD
role: PRINCIPAL_INVESTIGATOR
References: