60 Participants Needed

High-Protein Formula for Type 2 Diabetes

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Overseen ByJaime Jacob, BS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Joslin Diabetes Center
Must be taking: Incretin-mimetics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how a high-protein drink, known as the High-Protein Diabetes Formula, affects muscle mass in individuals with type 2 diabetes who are starting new diabetes medications. Participants will either consume two shakes daily or continue their usual diabetes care. It suits those who have had type 2 diabetes for at least three months, are about to begin certain diabetes treatments, and have a BMI of 25 or higher. As an unphased trial, this study provides a unique opportunity to contribute to understanding how dietary changes can support diabetes management.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop your current medications. However, since the study involves starting a new diabetes treatment, it's best to discuss your current medications with the trial team.

Is there any evidence suggesting that the High-Protein Diabetes Formula is likely to be safe for humans?

Studies have shown that high-protein diets can be safe and helpful for people with type 2 diabetes. Research indicates that these diets can lead to more weight loss and better control of blood sugar levels, potentially managing diabetes without harm.

Ensure, one of the high-protein shakes in the study, has been safely used by many people. It is designed to stay within safe intake levels, indicating it is well-tolerated by most users. Additionally, a diabetes-specific formula improved blood sugar levels after meals, demonstrating its safety and effectiveness.

Overall, these findings suggest that the high-protein diabetes formula used in the study is likely safe for participants.12345

Why do researchers think this study treatment might be promising for type 2 diabetes?

Researchers are excited about the High-Protein Diabetes Formula because it introduces a novel dietary approach to managing Type 2 diabetes. Unlike traditional treatments that often focus on medications like metformin or insulin to control blood sugar levels, this formula emphasizes increasing protein intake through specialized shakes. The unique aspect of this treatment is its potential to regulate glucose levels by altering macronutrient composition, possibly offering an alternative or complementary option that is easy to incorporate into daily life. This could be particularly beneficial for individuals looking to manage their condition with fewer medications.

What evidence suggests that this high-protein diabetes formula is effective for type 2 diabetes?

Research has shown that high-protein diets can help control blood sugar and prevent diabetes. Studies indicate that combining a high-protein diet with exercise aids in weight loss and improves health in overweight and obese individuals with type 2 diabetes. These diets specifically reduce blood sugar spikes after meals and lower average blood sugar levels. One study found that both high-protein and moderate-protein diets effectively manage type 2 diabetes. This trial will test high-protein formulas to determine if they improve muscle mass and manage diabetes effectively.6789

Who Is on the Research Team?

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Osama Hamdy, MD, PhD

Principal Investigator

Joslin Diabetes Center

Are You a Good Fit for This Trial?

This trial is for overweight or obese adults aged 18-75 with type 2 diabetes, diagnosed at least 3 months ago. Participants must have a BMI of ≥25 kg/m² and be starting treatment with incretin-mimetic drugs like semaglutide, tirzepatide, or dulaglutide.

Inclusion Criteria

I am between 18 and 75 years old.
I was diagnosed with type 2 diabetes over 3 months ago.
My BMI is 25 or higher.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive two HP-DSF shakes daily while initiating treatment with incretin-mimetic drugs

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • High-Protein Diabetes Formula

Trial Overview

The study tests if a high-protein diabetes-specific formula can increase lean muscle mass in patients who are beginning treatments with incretin mimetics for type 2 diabetes.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Participants will be instructed to drink two HP-DSF shakes (Protality Base or Ensure Max Protein byExperimental Treatment1 Intervention
Group II: Participants in this control group will follow the regular standard of diabetes careActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Joslin Diabetes Center

Lead Sponsor

Trials
98
Recruited
26,500+

Abbott

Industry Sponsor

Trials
760
Recruited
489,000+
Dr. Etahn Korngold profile image

Dr. Etahn Korngold

Abbott

Chief Medical Officer

MD, Harvard Medical School

Robert B. Ford profile image

Robert B. Ford

Abbott

Chief Executive Officer since 2020

Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business

Citations

Can high-protein diabetes-specific oral nutritional ... - PMC - NIH

High-protein diets, known to improve glucose control and prevent diabetes, can utilize rich-protein oral nutritional supplements. The study aims ...

Optimizing the lifestyle of patients with type 2 diabetes ...

A high-protein diet with resistance exercise training improves weight loss and body composition in overweight and obese patients with type 2 diabetes. Diabetes ...

Both high-protein and normal-protein diets are effective for ...

Both a high-protein diet (40 percent of total calories from protein) and a moderate-protein diet (21 percent of total calories from protein) were effective in ...

Glycemic Control in Diabetic Patients Receiving a ...

This study demonstrated that the use of specialized formulas significantly reduces postprandial glycemic response, mean BG levels, and insulin ...

Nutritional Strategies for the Management of Type 2 Diabetes ...

Other studies lasting 4 to 24 weeks reported that high-protein diets (25–32% of TEV) resulted in 2 kg more weight loss and a 0.5% greater improvement in HbA1C, ...

Nutrition Questions & Answers | Ensure®

... diet. The maximum amount of Ensure High Protein that someone can consume per day is 2 servings. This level will not exceed the Upper Tolerable Intake Levels ...

Administration of a diabetes-specific formula can improve ...

The diabetes-specific formula significantly decreased postprandial blood glucose levels and improved postprandial glycemic control in GDM patients.

Ensure® Diabetes Care: Specialized Health Drink for Diabetics

Choose Ensure® Diabetes Care: Scientifically-formulated health drink for diabetics. Clinically Proven To Help Manage Blood Sugar Levels in 4 Weeks!

Harvard Health Ad Watch: Are nutritional drinks actually ...

The Ensure commercial, meanwhile, suggests that while exercise might be a chore, at least your nutrition will be covered by this high-protein ...