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Nutritional Supplement

Nutritional Supplement for Type 2 Diabetes

Phase 1

Waitlist Available

Research Sponsored by Nimble Science Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged 40-65 years old at the inclusion of the study, both female and male subjects

Is taking a maximum of 3 oral anti-diabetic drugs, one of which must be Metformin. Other class of medications permitted include: Sulfonylurea, SGLT2 inhibitors, and DPP4 inhibitors

Must not have

Antibiotic use (except for topical use) ≤ 12 weeks prior to screening. Potential participants may be eligible once a 12-week washout is completed

Has blood or blood-related diseases (e.g. hemophilia, thalassemia, sickle cell disease, hereditary spherocytosis, glucose-6-phosphate dehydrogenase deficiency)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up compared from baseline, midpoint to endpoint (completion), an average of 6 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see how taking a specific nutrition supplement by mouth can help control type-2 diabetes by looking at the unique genetic information in the small intestine. "This trial aims to investigate how an

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not explicitly listed but may include digestive discomfort due to changes in diet from consuming the nutritional supplement.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 40 and 65 years old.

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I am on 3 or fewer diabetes medications, including Metformin.

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I can swallow a large capsule.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have a blood or blood-related disease.

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I have type 1 diabetes or have had diabetic ketoacidosis.

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I do not have chronic infectious diseases like active TB, Hepatitis C, or HIV.

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I have not been treated for cancer, except for skin cancer, in the last 6 months.

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I haven't taken any drugs that affect my stomach movement, except for my usual medicines and laxatives.

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I haven't had an infection, surgery, or systemic steroid treatment in the last 3 months.

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I have a history of gastrointestinal issues causing blockages.

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I have had a fecal microbiota transplantation before.

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I use insulin or GLP1 agonists to manage my blood sugar.

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I have a swallowing disorder that could make taking pills dangerous.

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I have a diagnosed condition that affects how my stomach or intestines move food.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ compared from baseline, midpoint to endpoint (completion), an average of 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~compared from baseline, midpoint to endpoint (completion), an average of 6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and compared from baseline, midpoint to endpoint (completion), an average of 6 weeks for reporting.