Feasibility Testing of Plant-Based Meal Replacement Products Made With Manitoba Crop Ingredients for Weight Loss and Diabetes Remission
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Meal Replacement.
- Who it may be relevant to
- Registry conditions: Weight Loss, Prediabetes, Diabetes. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Primary outcome measures
- Feasibility of incorporating the WI meal replacements into their weight loss clinic design. [Time frame: At Enrollment (Week 0) and End of Study (Week 16)]
Secondary outcome measures (7)
- Changes in Body Weight [Time frame: At Enrollment (Week 0) and End of Study (Week 16)]
- Changes in Waist Circumference [Time frame: At Enrollment (Week 0) and End of Study (Week 16)]
- Changes in BMI [Time frame: At Enrollment (Week 0) and End of Study (Week 16)]
- Cardiovascular Assessment [Time frame: At Enrollment (Week 0) and End of Study (Week 16)]
- Changes is Quality of Life [Time frame: At Enrollment (Week 0) and End of Study (Week 16)]
- Changes in Medication [Time frame: At Enrollment (Week 0) and End of Study (Week 16)]
- Changes in HemaglobinA1C [Time frame: At Enrollment (Week 0) and End of Study (Week 16)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- Seven Oaks Hospital Chronic Disease Innovation Centre — Winnipeg
Identifiers
NCT: NCT06614543 · HS26095 (B2023:073)