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

30 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment Oral nutritional supplement for Type 2 Diabetes?

Research shows that diabetes-specific oral nutritional supplements can improve blood sugar control in people with type 2 diabetes by using special ingredients like slowly-digestible carbohydrates and healthy fats. These supplements have been found to help manage blood sugar levels and improve overall health outcomes in both short- and long-term studies. ^{1 2 3 4 5}

Is the nutritional supplement for Type 2 Diabetes generally safe for humans?

While many people use dietary supplements, there are some risks, including potential side effects and interactions with other medications. Serious adverse events are rare but have been reported, especially with supplements for weight loss and blood sugar control. It's important to talk to your healthcare provider about any supplements you are considering. ^{5 6 7 8 9}

How is the oral nutritional supplement treatment for type 2 diabetes different from other treatments?

This oral nutritional supplement is unique because it is specifically designed for diabetes, containing slowly-digestible carbohydrates and healthy fats, which help improve blood sugar control and provide long-term benefits for managing diabetes. Unlike standard treatments, it can be used as a meal replacement to help manage weight and blood sugar levels effectively. ^{2 3 4 5 10}

What is the purpose of this trial?

This study aims to study the effect of an oral nutrition supplement to help manage type-2 diabetes by capturing the metagenomic fingerprint of the small-intestine.

Eligibility Criteria

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 haven't taken any antibiotics (except skin ones) in the last 12 weeks.

I don't have clotting or bleeding issues, or I'm safely on Plavix or similar.

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. Netherlands 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. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

A Diabetes-specific Oral Nutritional Supplement Improves Glycaemic Control in Type 2 Diabetes Patients. [2017]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Is There a Role for Diabetes-Specific Nutrition Formulas as Meal Replacements in Type 2 Diabetes? [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Nutritional supplements and their effect on glucose control. [2021]

5. Singapore pubmed.ncbi.nlm.nih.gov

Natural supplements for improving insulin sensitivity and glucose uptake in skeletal muscle. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Adverse Effects of Nutraceuticals and Dietary Supplements. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Dietary supplements in the management of diabetes: potential risks and benefits. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Serious Adverse Events Reported with Dietary Supplement Use in the United States: A 2.5 Year Experience. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Adverse events associated with dietary supplements: an observational study. [2015]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Parenteral vitamin D supplementation is superior to oral in vitamin D insufficient patients with type 2 diabetes mellitus. [2018]