Meal Replacements for Weight Loss and Diabetes

Overseen By Dr Dylan MacKay, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Manitoba

Disqualifiers: Pregnancy, Allergies, Eating disorder

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is it safe to use meal replacements for weight loss and diabetes management?

Research suggests that meal replacements, especially in beverage form, are generally considered safe for use in weight loss and diabetes management, though further studies are needed to identify who benefits most from them. ^{1 2 3 4 5}

How do meal replacements differ from other treatments for weight loss and diabetes?

Meal replacements offer a structured meal plan that can be more effective for weight loss and diabetes management compared to conventional diets. They provide a calorie-controlled, nutritionally balanced option that has shown greater weight loss results in patients with type-2 diabetes over time. ^{2 4 6 7 8}

What data supports the effectiveness of the treatment WI Meal Replacements for weight loss and diabetes?

Research shows that meal replacements can help people with type 2 diabetes lose weight and control their blood sugar levels better than regular diets. In studies, people using meal replacements lost more weight over time compared to those on conventional diets, making it a promising option for managing diabetes and obesity. ^{2 5 6 8 9}

Who Is on the Research Team?

Dr Dylan MacKay, PhD

Principal Investigator

University of Manitoba

Are You a Good Fit for This Trial?

This trial is for individuals with obesity, diabetes, or prediabetes who are interested in weight loss and diabetes remission. Participants should be willing to follow the Wellness Institute's Weight Loss Clinic program for 16 weeks and log their meal replacement consumption.

Inclusion Criteria

Live within the province of MB

Ability to give written informed consent in English

Enrolled in the Wellness Institute Weight Loss Clinic

Exclusion Criteria

Participants with known allergies to the meal replacement ingredients

Has an active eating disorder

I am not pregnant, breastfeeding, nor planning to become pregnant during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants follow the WLC program for 16 weeks, with the intervention group incorporating meal replacements

16 weeks

Regular visits as per WLC program schedule

Follow-up

Participants are monitored for changes in dietary intake, physical activity, and health markers

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• WI Meal Replacements

Trial Overview The study tests if adding plant-based meal replacements (bars or shakes) to a weight loss clinic program can help with weight loss and improve lifestyle behaviors compared to the same program without these products. It also looks at whether it helps in reversing diabetes.

How Is the Trial Designed?

Group I: The WLC program plus meal replacements Active Control 1 Intervention

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 II: The WLC program only Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Manitoba

Lead Sponsor

Trials

628

Recruited

209,000+

Sustainable Canadian Agricultural Partnership

Collaborator

Trials

1

Recruited

40+

Seven Oaks Hospital Chronic Disease Innovation Centre

Collaborator

Trials

4

Recruited

210+

The Wellness Institute

Collaborator

Trials

2

Recruited

100+

Published Research Related to This Trial

In a 12-week study involving 75 obese patients with type 2 diabetes, liquid meal replacements (MRs) were found to be safe and effective for weight loss, with participants losing an average of 6.4% to 6.7% of their body weight.

Participants using MRs also experienced significant improvements in fasting glucose levels and reductions in total cholesterol and LDL cholesterol compared to those on an exchange diet plan, indicating additional health benefits beyond weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liquid meal replacements and glycemic control in obese type 2 diabetes patients. Yip, I., Go, VL., DeShields, S., et al.[2022]

Liquid meal replacements in weight loss diets for overweight/obese individuals with type 2 diabetes resulted in modest reductions in body weight (average -2.37 kg) and improvements in several cardiometabolic risk factors, including BMI, waist circumference, and blood pressure, based on a review of 9 trials involving 961 participants over a median follow-up of 24 weeks.

While there were significant improvements in weight and metabolic markers like HbA1c and fasting glucose, the overall certainty of the evidence was low to moderate, indicating a need for more high-quality studies to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Liquid Meal Replacements on Cardiometabolic Risk Factors in Overweight/Obese Individuals With Type 2 Diabetes: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Noronha, JC., Nishi, SK., Braunstein, CR., et al.[2020]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Impact of Partial Meal Replacement on Glycemic Levels and Body Weight in Indian Patients with Type 2 Diabetes (PRIDE): A Randomized Controlled Study. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Predictors of programme adherence and weight loss in women in an obesity programme using meal replacements. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

Liquid meal replacements and glycemic control in obese type 2 diabetes patients. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

How best to use partial meal replacement in managing overweight or obese patients with poorly controlled type 2 diabetes. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Do meal replacement drinks have a role in diabetes management? [2019]

6. Spain pubmed.ncbi.nlm.nih.gov

[Analysis of a weight loss program with meal replacement products on weight and biochemical markers in overweight or type I obese patients]. [2015]

7. United States pubmed.ncbi.nlm.nih.gov

Meal replacements and energy balance. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

The Effect of Liquid Meal Replacements on Cardiometabolic Risk Factors in Overweight/Obese Individuals With Type 2 Diabetes: A Systematic Review and Meta-analysis of Randomized Controlled Trials. [2020]

9. England pubmed.ncbi.nlm.nih.gov

The role of meal replacements in obesity treatment. [2006]