Nutritional Supplement for Type 2 Diabetes

Overseen By Isaac Wong, MBT

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Nimble Science Ltd.

Must be taking: Metformin

Must not be taking: Insulin, GLP1 agonists

Disqualifiers: Type 1 diabetes, Renal disease, Hepatic disease, Cancer, others

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

Compensation: Varies

Number of Visits: 4

Duration: 6 weeks

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. ^{1 2 3 4 5}

Why 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. ^{6 7 8 9 10}

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

Has type 2 diabetes as evidenced by their medical history charts and is able to maintain number of medications, type and dose throughout the duration of the study

My HbA1c level is between 6.5% and 9.5%.

My BMI is between 20 and 29.9.

Exclusion Criteria

I have not had a blood transfusion in the last 3 weeks.

I have a blood or blood-related disease.

Allergic or intolerant to any ingredient found in the study products

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Collection of baseline samples for metagenomic and metabolomic analysis

1 week

1 visit (in-person)

Treatment

Participants ingest the oral nutrition supplement and samples are collected at baseline, midpoint, and endpoint

6 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Oral nutritional supplement

Trial Overview

The trial is testing an oral nutritional supplement's impact on the gut microbiome of diabetic patients. Participants will consume the supplement and undergo assessments to see if it helps manage their diabetes by altering the microorganisms in their small intestine.

How Is the Trial Designed?

Group I: Interventional Arm Experimental Treatment 1 Intervention

Ingestion of the ONS

Who Is Running the Clinical Trial?

Nimble Science Ltd.

Lead Sponsor

Trials

11

Recruited

570+

Abbott Nutrition

Industry Sponsor

Trials

173

Recruited

33,700+

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

Trials

827

Recruited

902,000+

Alberta Obesity Centre

Collaborator

Published Research Related to This Trial

Out of 41,121 reported adverse events related to dietary supplements, only 203 (0.48%) were classified as serious adverse events (SAEs), indicating a low incidence of serious issues among users.

The majority of SAEs were linked to weight loss (69.0%) and glycemic control (19.2%) supplements, with cardiovascular, gastrointestinal, and nervous system disorders being the most affected organ systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious Adverse Events Reported with Dietary Supplement Use in the United States: A 2.5 Year Experience. Schmitz, SM., Lopez, HL., Mackay, D., et al.[2020]

Diabetes-specific nutrition formulas (DSNFs) are designed with slowly-digestible carbohydrates and healthy fats, showing significant improvements in post-meal blood sugar levels and long-term glycemic control in patients with type 2 diabetes (T2D).

Clinical trials indicate that DSNFs not only help manage blood sugar levels but also positively impact various cardiometabolic health outcomes, making them a valuable tool in nutrition therapy for T2D.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is There a Role for Diabetes-Specific Nutrition Formulas as Meal Replacements in Type 2 Diabetes? Noronha, JC., Mechanick, JI.[2023]

In a study of 136 Japanese adults with type 2 diabetes, individualized dietary advice led to a greater reduction in HbA1c levels (-1.1%) compared to conventional dietary advice (-0.7%) over 6 months, indicating its effectiveness in managing blood sugar levels.

Participants receiving individualized advice also made healthier dietary changes, such as reducing energy intake and consumption of sweets and fats, which contributed to improvements in weight and lipid profiles, although these changes were not significantly different from the conventional group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of individualized dietary advice compared with conventional dietary advice for adults with type 2 diabetes: A randomized controlled trial. Omura, Y., Murakami, K., Matoba, K., et al.[2022]

Over 70% of Americans use dietary supplements daily, yet these products are not required to be approved by the FDA before being sold, leading to potential safety concerns.

While many supplements are widely consumed, there is limited evidence supporting their health benefits in well-nourished adults, and some can cause significant toxicity or interact negatively with prescription medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Effects of Nutraceuticals and Dietary Supplements. Ronis, MJJ., Pedersen, KB., Watt, J.[2020]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9692739/

Real World Practice Study of the Effect of a Specific Oral ...

Real-life study of one arm in 60 patients with diabetes and prediabetes, performing a dietary adaptation with diabetes-specific oral nutritional ...

2.

frontiersin.org

frontiersin.org/journals/nutrition/articles/10.3389/fnut.2021.680700/full

The Effect of Oral Nutritional Formula With Three Different ...

Overall, the data suggested that consumption of SP, SPP, LCSSPG Oral-formula may be beneficial for the treatment of T2DM.

3.

mdpi.com

mdpi.com/2308-3417/9/4/104

Effects of a Specialized Oral Nutritional Supplement with ...

Primary outcome was change in body weight from baseline to day 60. Nutritional status, energy, and macronutrient intakes were measured. A ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S2212109924000827

The Use of a Specialized Oral Nutritional Supplement in ...

The results demonstrate that the use of specialized ONS, when compared with control ONS, proved to be cost saving (cheaper and more effective), considering the ...

5.

drc.bmj.com

drc.bmj.com/content/4/1/e000240

Plasma glucose and insulin response to two oral nutrition ...

These specialized formulations have demonstrated greater benefit in the normalization of fasting and postprandial glucose concentrations. This ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7887529/

Safety and Efficacy of Dietary Supplements for Diabetes

For many dietary supplements, data are lacking on important information such as mechanisms of action, pharmacokinetics, and potential toxicity.

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05913193

NCT05913193 | Oral Nutritional Supplement in Type 2 ...

Type 2 diabetes on treatment with one or more oral antidiabetics/insulin and constant dose for at least 2 months · Has HbA1c < 9.0% based on recent (30 days ...

8.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0168822707005694

Long-term use of a diabetes-specific oral nutritional ...

These data demonstrate that diabetic patients at risk for malnutrition benefit from use of this diabetes-specific ONS to improve postprandial blood glucose ...

9.

mdpi.com

mdpi.com/2072-6643/14/11/2295

Efficacy and Safety of Nutrient Supplements for Glycaemic ...

Nutrient supplements are widely used for type 2 diabetes (T2D), yet evidence-based guidance for clinicians is lacking.

10.

nature.com

nature.com/articles/s41387-020-0117-6

Use and abuse of dietary supplements in persons with ...

The aggregated set of studies suggest there is little clinical evidence for the use of dietary supplements to reduce or control diabetes.