90 Participants Needed

Meal Replacement Shake for Type 2 Diabetes

(PIPC Trial)

CS
Overseen ByCathy Sun, MD MSc
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Ottawa Hospital Research Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

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 data supports the effectiveness of the treatment Boost Original meal replacement shake for type 2 diabetes?

Research shows that using meal replacement shakes can help people with type 2 diabetes improve their blood sugar control and reduce weight. Studies have found that replacing meals with these shakes can lead to better long-term blood sugar levels and lower cardiometabolic risk factors.12345

Is the meal replacement shake safe for people with type 2 diabetes?

Research indicates that meal replacement shakes have been studied for safety in people with type 2 diabetes, and they are generally considered safe for use in managing the condition.13467

How does the Boost Original meal replacement shake differ from other treatments for type 2 diabetes?

The Boost Original meal replacement shake offers a unique approach by providing a structured meal replacement option that can help manage blood sugar levels and support weight loss, which are crucial for type 2 diabetes management. Unlike traditional medications, it focuses on dietary changes and can be tailored to individual needs, potentially leading to long-term improvements in blood sugar control and overall health.12347

What is the purpose of this trial?

The standard treatment for Type 2 diabetes involves management of the disease based on average of blood glucose control over the past few months.In this study, the investigators test for the participants' ability to produce insulin, which is the hormone that the body makes to control blood sugar levels. The body produces insulin in response to eating. The participants will drink a meal replacement shake, and then test the blood for levels of insulin produced over 2 hours.With blood tests taken five times over two hours, the investigators will measure the blood glucose (sugar), and insulin levels. This study will assess the differences in insulin produced in the participants and try to understand the reasons for these differences.

Research Team

CS

Cathy Sun, MD MSc

Principal Investigator

Ottawa Hospital Research Institute

Eligibility Criteria

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

I am not taking insulin for diabetes.
Consent provided
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

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

Treatment Details

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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Pancreatic insulin production after drinking meal replacement shakeExperimental Treatment1 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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials
585
Recruited
3,283,000+

Findings from Research

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

References

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. [2021]
Individualized Meal Replacement Therapy Improves Clinically Relevant Long-Term Glycemic Control in Poorly Controlled Type 2 Diabetes Patients. [2022]
Efficacy and Safety of Meal Replacement in Patients With Type 2 Diabetes. [2023]
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]
Efficacy of meal replacements versus a standard food-based diet for weight loss in type 2 diabetes: a controlled clinical trial. [2022]
Liquid meal replacements and glycemic control in obese type 2 diabetes patients. [2022]
A head-to-head comparison of the postprandial effects of 3 meal replacement beverages among people with type 2 diabetes. [2021]
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