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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if adding plant-based meal replacements to a weight loss program aids in weight loss and managing diabetes or pre-diabetes. Participants will follow a 16-week weight loss plan, with some using meal replacements like bars or shakes (referred to as WI Meal Replacements). The goal is to assess whether these meal replacements improve lifestyle habits and reduce risks for chronic diseases. Eligible participants include those already in the Wellness Institute's Weight Loss Clinic and residing in Manitoba. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance weight loss strategies and improve health outcomes.

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 prior data suggests that these meal replacements are safe for weight loss and diabetes management?

A previous study on meal replacements found that most participants reported only mild side effects. Out of 118 participants, only two experienced serious issues. Another study demonstrated that liquid meal replacements were safe for 75 overweight individuals with type 2 diabetes, with no major safety problems over 12 weeks. Overall, research indicates that these meal replacements are generally safe and well-tolerated by most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about WI Meal Replacements for weight loss and diabetes because they offer a flexible and practical approach to managing these conditions. Unlike traditional treatments that might involve multiple medications or intensive lifestyle changes, this method allows participants to choose between convenient meal replacement bars or shakes. This choice not only simplifies meal planning but also supports consistent calorie control, which is crucial for weight management and blood sugar regulation. By integrating meal replacements into a weight loss program, this treatment could make it easier for people to stick to their health goals, potentially leading to better long-term outcomes.

What evidence suggests that WI meal replacements could be effective for weight loss and diabetes?

Research has shown that meal replacements can aid in weight loss and better diabetes management. Specifically, individuals with type 2 diabetes who used meal replacements lost about 5% of their body weight over six to twelve months. One study found that meal replacements controlled blood sugar levels more effectively than standard diabetes treatments like metformin. Additionally, a review indicated that meal replacements can reduce weight and improve health markers such as blood sugar levels. In this trial, participants in one arm will follow the WLC program with meal replacements, while another arm will follow the WLC program only. These findings suggest that meal replacements might be a useful tool for weight loss and diabetes management. ^{1 2 6 7 8}

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.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3468055/

Meal Replacements for Weight Loss in Type 2 Diabetes in a ...

In a report by Ditschuneit (2006) patients with diabetes on a meal replacement program achieved weight loss of 5.2% and 4.4% of their body weight at 6 and 12 ...

2.

diabetesjournals.org

diabetesjournals.org/care/article/26/9/2505/22568/One-Year-Outcome-of-a-Combination-of-Weight-Loss

One-Year Outcome of a Combination of Weight Loss ...

CONCLUSIONS—This combination weight loss program resulted in greater weight loss and improved diabetes control compared with a standard weight ...

3.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2820237

A 5:2 Intermittent Fasting Meal Replacement Diet and ...

In this randomized clinical trial of 405 adults, the 5:2 MR approach achieved better glycemic control at 16 weeks compared with metformin and empagliflozin.

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S002231662302967X

Meal Replacements Are as Effective as Structured Weight ...

Weight loss was 6.0 ± 4.2 kg (6.3%) for the MR group and 6.6 ± 3.4 kg (6.9%) for the C group at 3 mo, and 9.0 ± 6.9 kg (9.4%) for the MR group and 9.2 ± 5.1 kg ...

5.

wjgnet.com

wjgnet.com/1948-9358/full/v16/i8/104371.htm

A systematic scoping review of meal replacements in type ...

The primary outcomes extracted included the types and dosage of meal replacements and their effects on HbA1c, glucose levels, and weight ...

6.

sciencedirect.com

sciencedirect.com/science/article/pii/S0002916523132989

changes in risk factors in 118 patients with long-term follow ...

Side effects were mild, and only 2 patients had severe or serious adverse events. At an average of 5 y of follow-up, patients were maintaining an average weight ...

7.

researchgate.net

researchgate.net/publication/345941569_Meal_replacement_by_formula_diet_reduces_weight_more_than_a_lifestyle_intervention_alone_in_patients_with_overweight_or_obesity_and_accompanied_cardiovascular_risk_factors-the_ACOORH_trial

(PDF) Meal replacement by formula diet reduces weight ...

This weight loss reflects a significantly greater reduction in fat mass at 52 weeks among participants receiving MR compared to participants ...

8.

withpower.com

withpower.com/trial/phase-type-2-diabetes-mellitus-5-2024-50077

Meal Replacement Shake for Type 2 Diabetes

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 ...