Meal Replacement Shake for Type 2 Diabetes

(PIPC Trial)

Overseen By Cathy Sun, MD MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ottawa Hospital Research Institute

Must not be taking: Insulin

Disqualifiers: Other diabetes, Allergies, Fasting issues

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how well people with Type 2 diabetes produce insulin after consuming a Boost Original meal replacement shake. Researchers will measure participants' blood sugar and insulin levels over two hours to assess their body's response. The goal is to identify differences in insulin production among participants. This trial is suitable for individuals with Type 2 diabetes who are not currently using insulin therapy and can fast overnight. As an unphased trial, it offers participants the opportunity to contribute to important research that could enhance the understanding and management of Type 2 diabetes.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, you cannot be on insulin therapy to participate.

What prior data suggests that this meal replacement shake is safe for participants with Type 2 diabetes?

Research has shown that meal replacements, such as the Boost Original shake, are safe for individuals with type 2 diabetes. In one study involving 75 participants who were obese and had type 2 diabetes, these meal replacements proved safe and effective for weight loss. Another study demonstrated that using meal replacements improved blood sugar control and aided in weight loss.

Additionally, Boost Glucose Control drinks, similar to the Boost Original shake, caused a smaller increase in blood sugar compared to regular nutritional drinks in people with type 2 diabetes. Overall, these findings suggest that the Boost Original meal replacement shake is well-tolerated and safe for managing type 2 diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for Type 2 diabetes, which often include medications like metformin or insulin injections, the Boost Original meal replacement shake offers a nutritional intervention that may enhance pancreatic insulin production. Researchers are excited about this approach because it focuses on the potential of dietary management to directly support the body's natural insulin production, which could lead to better blood sugar control. This method is unique as it integrates a simple, everyday product into diabetes management, offering a potentially more accessible and less invasive treatment option compared to traditional pharmaceuticals.

What evidence suggests that this meal replacement shake might be an effective treatment for Type 2 diabetes?

Research shows that meal replacement shakes can help people manage type 2 diabetes. One study found that these shakes led to significant weight loss in patients with type 2 diabetes. Another review found that meal replacements improved blood sugar control and reduced body fat. Additionally, a specific diabetes nutrition shake lowered blood sugar spikes after meals by 47%. This trial will investigate the effects of the Boost Original meal replacement shake on pancreatic insulin production. These findings suggest that meal replacement shakes could effectively help control blood sugar and manage weight in people with type 2 diabetes. ^{1 2 6 7 8}

Who Is on the Research Team?

Cathy Sun, MD MSc

Principal Investigator

Ottawa Hospital Research Institute

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Type 2 diabetes who are not on insulin therapy. Participants must have given consent and be diagnosed with type 2 diabetes mellitus.

Inclusion Criteria

Consent provided

I am not taking insulin for diabetes.

I have been diagnosed with type 2 diabetes.

Exclusion Criteria

Allergic to one or more ingredients in Boost meal replacement shake

Unable to fast since midnight and attend in person for the morning protocol.

I have been diagnosed with a form of diabetes that is not type 1 or type 2.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Study Visit

Participants consume a meal replacement shake and undergo blood tests to measure insulin production over 2 hours

2 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Boost Original meal replacement shake

Trial Overview The study tests the body's ability to produce insulin after drinking a Boost Original meal replacement shake. Blood glucose and insulin levels will be measured five times over two hours to assess pancreatic function.

How Is the Trial Designed?

Group I: Pancreatic insulin production after drinking meal replacement shake Experimental Treatment 1 Intervention

Nutritional intervention, and then blood work will be drawn to measure pancreatic insulin production capacity.

Boost Original meal replacement shake is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Boost Original for:

• Nutritional supplement
• Meal replacement

Approved in Canada as Boost Original for:

• Nutritional supplement
• Meal replacement

Approved in European Union as Boost Original for:

• Nutritional supplement
• Meal replacement

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials

585

Recruited

3,283,000+

Published Research Related to This Trial

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]

A study involving 309 participants with poorly controlled type 2 diabetes showed that individualized low-carbohydrate meal replacement diets significantly improved HbA1c levels, weight, and cardiometabolic risk factors after 52 weeks, particularly in those who had three meal replacements per day.

The stringent meal replacement group (three meals/day) achieved a clinically relevant HbA1c reduction of -0.81% after one year, while the moderate group (two meals/day) did not show significant differences compared to the control group, highlighting the importance of meal frequency in managing diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individualized Meal Replacement Therapy Improves Clinically Relevant Long-Term Glycemic Control in Poorly Controlled Type 2 Diabetes Patients. Kempf, K., Röhling, M., Niedermeier, K., et al.[2022]

Meal replacement (MR) significantly improves glycemic control and reduces body weight in type 2 diabetes (T2D) patients compared to conventional diabetic diets, with a notable reduction in HbA1c by 0.46% and body weight by 2.43 kg based on a meta-analysis of 17 randomized controlled trials involving 2112 participants.

Total meal replacement with caloric restriction showed the greatest benefits, leading to a more significant reduction in HbA1c, fasting blood glucose, and body weight, indicating that both total MR and appropriate calorie restriction are effective strategies for managing T2D.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Meal Replacement in Patients With Type 2 Diabetes. Ye, W., Xu, L., Ye, Y., et al.[2023]

In a pilot study involving 81 adults with type 2 diabetes, using a diabetes-specific nutritional shake (DSNS) as a breakfast replacement led to significantly greater reductions in postprandial glycemic response compared to those who maintained their usual diets.

Participants who consumed DSNS not only improved their glycemic control but also reported reduced cravings for starchy foods and increased confidence in managing their diabetes through dietary choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a diabetes-specific nutritional shake to replace a daily breakfast and afternoon snack improves glycemic responses assessed by continuous glucose monitoring in people with type 2 diabetes: a randomized clinical pilot study. Mustad, VA., Hegazi, RA., Hustead, DS., et al.[2021]

In a study involving 18 participants with type 2 diabetes, the Glucerna Weight Loss Shake was found to produce the best postprandial glucose response compared to Slim-Fast Shake and Ensure with Fiber Shake, indicating it may be a safer option for managing blood sugar levels.

Despite Glucerna's superior performance, 22% of subjects still exceeded the American Diabetes Association's recommended upper limit for postprandial blood glucose, highlighting the need for careful monitoring of glycemic responses to meal replacement beverages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A head-to-head comparison of the postprandial effects of 3 meal replacement beverages among people with type 2 diabetes. Fonda, SJ., Jain, A., Vigersky, RA.[2021]

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]

In a study involving 119 participants with type 2 diabetes, a portion-controlled meal replacement diet (PCD) led to significantly greater weight loss at 34 weeks compared to a standard diet (SD), with about 40% of PCD participants losing at least 5% of their initial weight versus only 12% in the SD group.

The PCD not only resulted in better weight loss but also showed higher retention rates and easier adherence among participants, suggesting it could be a more effective strategy for long-term weight management in obese patients with type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of meal replacements versus a standard food-based diet for weight loss in type 2 diabetes: a controlled clinical trial. Cheskin, LJ., Mitchell, AM., Jhaveri, AD., et al.[2022]

Citations

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

Meal Replacement Shake for Type 2 Diabetes (PIPC 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12362476/

A systematic scoping review of meal replacements in type 2 ... Key findings included significant improvements in hemoglobin A1c and body mass index after meal replacement interventions, with notable efficacy when combined ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7686729/

Meal replacement in dietary management of type-2 ... The main outcome of the data will be the type and dosage of meal replacement and its effect on HbA1c, glucose, and weight reduction. An additional outcome will ...

4. aapa.org aapa.org/news-central/2020/10/take-the-guess-work-out-meal-replacement-study-results-can-help-pas-advise-patients-with-type-2-diabetes/

Take the Guesswork Out: Meal Replacement Study Results ... The study shows that drinking a diabetes-specific nutrition shake was associated with a 47% reduction in post-meal peak glucose after breakfast, ...

5. researchgate.net researchgate.net/publication/43349700_Weight_Management_Using_a_Meal_Replacement_Strategy_in_Type_2_Diabetes

Weight Management Using a Meal Replacement Strategy ... Overweight and obese individuals with diabetes who attempt weight reduction face considerable challenges. However, several recent studies showed ...

6. nestle.com nestle.com/about/research-development/news/proprietary-protein-technology

Nestlé's protein expertise delivers weight management ... The study, which involved participants with type-2 diabetes, showed that a pre-meal drink containing 10 grams of the whey protein microgels ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37192345/

Efficacy and Safety of Meal Replacement in Patients With ... Compared with CDs, the MR-based dietary pattern further improved the glycemic control and adipose indicators in T2D patients.

8. ce.mayo.edu ce.mayo.edu/sites/default/files/BOOST%20ONS%20MALNUTRITION%20%26%20DIABETES.pdf

HELPING ADULT PATIENTS MEET THEIR NUTRITIONAL ... BOOST Glucose Control® Drinks are clinically shown to produce a lower blood sugar response vs. a standard nutritional drink in people with type 2 diabetes*1,2.