40 Participants Needed

Meal Replacements for Weight Loss and Diabetes

KC
DD
Overseen ByDr Dylan MacKay, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Manitoba
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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.

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.12345

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.23678

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.13589

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.

Research Team

DD

Dr Dylan MacKay, PhD

Principal Investigator

University of Manitoba

Eligibility Criteria

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

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

Treatment Details

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.
Participant Groups
2Treatment groups
Active Control
Group I: The WLC program plus meal replacementsActive Control1 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 onlyActive Control1 Intervention

Find a Clinic Near You

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+

Findings from Research

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.
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.
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]

References

Impact of Partial Meal Replacement on Glycemic Levels and Body Weight in Indian Patients with Type 2 Diabetes (PRIDE): A Randomized Controlled Study. [2022]
Predictors of programme adherence and weight loss in women in an obesity programme using meal replacements. [2013]
Liquid meal replacements and glycemic control in obese type 2 diabetes patients. [2022]
How best to use partial meal replacement in managing overweight or obese patients with poorly controlled type 2 diabetes. [2022]
Do meal replacement drinks have a role in diabetes management? [2019]
[Analysis of a weight loss program with meal replacement products on weight and biochemical markers in overweight or type I obese patients]. [2015]
Meal replacements and energy balance. [2022]
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]
The role of meal replacements in obesity treatment. [2006]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security