Nutritional Supplement for Type 2 Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how an oral nutritional supplement affects the gut health of people with type 2 diabetes. Researchers aim to observe changes in gut bacteria over time. This study suits individuals with type 2 diabetes who manage their condition with Metformin and up to two other oral medications. Participants should have stable weight and not currently use diabetes-specific nutritional supplements. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new supplement.
Will I have to stop taking my current medications?
The trial requires that you maintain your current diabetes medications, including Metformin and up to two other oral anti-diabetic drugs, throughout the study. However, you must stop taking any non-study diabetes-specific oral nutritional supplements and certain other medications or supplements that could affect blood glucose or metabolism at least four weeks before starting the trial.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research on oral nutritional supplements (ONS) for individuals with type 2 diabetes has shown mixed results regarding safety. Some studies indicate that these supplements can improve blood sugar levels after meals. However, limited information exists on how these supplements function in the body and their potential side effects.
Many individuals with diabetes use dietary supplements, but strong evidence confirming their safety or effectiveness is lacking. This study is in an early phase and focuses on understanding safety, so researchers are still carefully studying any potential risks.
Prospective participants should note that the main goal is to learn more about the supplement's safety and tolerability for people with diabetes.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for type 2 diabetes, which often include medications like metformin or insulin injections, this new approach uses an oral nutritional supplement. Researchers are excited about this treatment because it provides a non-pharmacological option that could complement or even reduce the need for traditional medications. This supplement is unique because it may help manage blood sugar levels through nutritional support, making it a potentially safer and more holistic option for patients. Additionally, being an oral supplement, it offers an easier and more convenient method of administration compared to injections.
What evidence suggests that this oral nutritional supplement might be an effective treatment for Type 2 Diabetes?
Research shows that special oral nutritional supplements (ONS), provided to participants in this trial, can help control blood sugar levels in people with type 2 diabetes. Studies have found that these supplements improve blood sugar levels both before and after meals, which is crucial for managing diabetes. In some cases, they are not only cost-effective but also outperform standard options. One study suggested that these supplements might aid overall diabetes treatment. While more research is needed, these early findings offer promise for those seeking new ways to manage their diabetes.678910
Are You a Good Fit for This Trial?
Adults aged 40-65 with type 2 diabetes, HbA1c levels between 6.5% and 9.5%, BMI of 20-29.9, stable weight, and taking up to three oral diabetic medications including Metformin can join this trial. They must not be pregnant or breastfeeding, have used certain supplements or antibiotics recently, have clotting disorders or active cancer, engage in strenuous exercise, or plan to become pregnant.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Collection of baseline samples for metagenomic and metabolomic analysis
Treatment
Participants ingest the oral nutrition supplement and samples are collected at baseline, midpoint, and endpoint
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Oral nutritional supplement
Find a Clinic Near You
Who Is Running the Clinical Trial?
Nimble Science Ltd.
Lead Sponsor
Abbott Nutrition
Industry Sponsor
Robert B. Ford
Abbott Nutrition
Chief Executive Officer since 2020
Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business
Melissa Brotz
Abbott Nutrition
Chief Marketing Officer
Bachelor's degree in Journalism from Northwestern University
University of Calgary
Collaborator
Alberta Obesity Centre
Collaborator