Type 2 DiabetesPhase 1NCT06704022
Assessing Gut Microbiome Changes Before and After an Oral Nutritional Supplement Intake Using the SIMBA Capsule in Diabetic Participants
A Phase 1 study testing Oral nutritional supplement in people with Type 2 Diabetes, run by Nimble Science Ltd. at 1 site in Canada.
Trial summary
This is a single-arm interventional clinical study, the primary objective is to assess the changes in the small intestinal (SI) metagenomic profile of in diabetic participants from baseline to midpoint and endpoint in response to the ONS intervention. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Oral nutritional supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2025to Aug 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 40-65 years old at the inclusion of the study, both female and male subjects.
- 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.
- Has HbA1c ≥ 6.5% and ≤ 9.5% based on a blood sample collected at the Screening Visit, documented within the past month or referred by a medical doctor.
- Normal to overweight (BMI 20-29.9).
- Weight is stable (has maintained current body weight within 3 kg) for the two months prior to the Baseline Visit.
- 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.
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- Either a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to the Baseline Visit.
- Willingness to follow the protocol as described, including consumption of study product per the protocol and completing any forms/questionnaires needed throughout the study.
- The participant is willing to refrain from taking non-study diabetes-specific oral nutritional formulas over the entire course of the study.
- Willing to maintain their diet and physical activity levels during the study.
- Able to swallow a 25mm length and 9mm width sized capsule.
- At least a four-week washout period between the completion of a previous research study that required ingestion of any study food or drug and their start in the current study. Signed Informed Consent; willing and able to comply with study procedures
Who cannot join
- Confirmed type 1 diabetes and/or had a history of diabetic ketoacidosis.
- Use of exogenous insulin or GLP1 agonists for glucose control.
- Using diabetes-specific oral nutritional supplements(s), (e.g. Glucerna®, Boost etc.) defined as more than one eating occasion per week within the past 4 weeks (those users who can stop using such products for ≥4 weeks before baseline visit need not be excluded).
- Follows a non-typical eating pattern such as very low carbohydrate diet (e.g., Adkins diet, ketogenic diet, high protein diet).
- Has eating disorder, severe dementia or delirium, history of significant neurological or psychiatric disorder, alcoholism, substance abuse or other conditions that may interfere with study product consumption or compliance with study protocol procedures in the opinion of the investigators.
- Galactosemia and lactose intolerance
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- A chronic disease which in the opinion of the investigator, would adversely affect study safety or outcome. Such as, but not limited to
- A significant cardiovascular event within 6 months prior to study entry or history of congestive heart failure, per physician evaluation.
- End-stage organ failure (such as end-stage renal disease) or is post-organ transplant.
- Current or history of renal disease or on dialysis or severe gastroparesis.
- Current diagnosed hepatic disease such as liver cirrhosis or late-stage liver fibrosis. Participants with prevalent angina will not be excluded.
- A chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis C, or HIV.
- Subject has current active malignant disease or was treated within the last 6 months for cancer, except basal or squamous cell skin carcinoma, prior to enrollment.
- Taking any herbals, dietary supplements, or medications during the past four weeks prior to baseline visit that could profoundly affect (in the opinion of the principal investigator or site physician) blood glucose, body weight, muscle, metabolism, appetite or microbiome (e.g. orlistat, contrave) (naltrexone/bupropion), Qsymia (phentermine/topiramate), Belviq (lorcaserin), incretin mimetics, other drugs indicated for weight loss, cannabis, glucocorticoids, prebiotics and probiotic supplements). Those users who have stopped using such supplements/ medications for ≥4 weeks prior to baseline need not be excluded).
- Use of any medications in the week prior to the screening study visit, unless part of regular treatment, that could substantially alter gastrointestinal motor function (e.g., opioids, anticholinergics, GLP-1 analogues); laxative use is allowed if it is kept unchanged in the week prior to the SIMBA capsule ingestion timepoints. Proton pump inhibitors (PPIs) are allowed provided a wash-out period of 48 hours is respected before swallowing the SIMBA capsules and PPI treatment is resumed only 4 hours thereafter.
- If willing prokinetic use can be discontinued for the study duration, with a washout period of 2 weeks
- Antibiotic use (except for topical use) ≤ 12 weeks prior to screening. Potential participants may be eligible once a 12-week washout is completed.
- Current infection (requiring medication and antibiotics), inpatient surgery or received systemic corticosteroid treatment [except for inhaled (includes nasal), topical, and ophthalmic steroids] in the last 3 months.
- Prior gastrointestinal disease, surgery, or radiation treatment which, in the Investigator's opinion, would interfere with consumption or digestion or absorption of study product, lead to intestinal structuring or obstruction with a risk of capsule non-excretion, including, e.g., achalasia, eosinophilic esophagitis, cancer diagnosis or previous esophageal, gastric, small intestinal, or colonic surgery. Appendectomy or cholecystectomy more than 3 months before the screening visit is acceptable.
- Diagnosed with Crohn's disease, ulcerative colitis or celiac disease.
- History of known structural gastrointestinal abnormalities such as structures or fistulas leading to mechanical obstruction.
- Organic motility disorder, including gastroparesis, intestinal pseudo-obstruction, systemic sclerosis, Ogilvie's syndrome.
- History of oropharyngeal dysphagia, or other swallowing disorder with a risk of capsule aspiration.
- History of less than three (3) bowel movements per week. 13) Consumption of probiotic or prebiotic capsule supplements within 1 month prior to screening. Potential participants may be eligible once a 1-month washout is completed.
- Any prior Fecal Microbiota Transplantation.
- Colon cleanses/bowel prep for 2 weeks.
- Clotting or bleeding disorders (the use of Plavix® or a similar anticoagulant drug with no reported difficulty during blood draws will be allowed as per physician's opinion).
- Has blood or blood-related diseases (e.g. hemophilia, thalassemia, sickle cell disease, hereditary spherocytosis, glucose-6-phosphate dehydrogenase deficiency).
- Received a blood transfusion within the last 3 weeks.
- Allergic or intolerant to any ingredient found in the study products.
- Habitually engages in strenuous exercise (e.g., high intensity aerobic exercise, including heavy physical labor), duration of 1 hour or longer, 3 or more times per week. Potential participants may be eligible to participate if their levels exercise are reduced.
- Participant is actively enrolled in a weight loss program.
- Are scheduled for an MRI at any time during the study. Potential participants may be eligible to participate once their MRI procedure is completed.
- Pregnant or breastfeeding.
- Planning to become pregnant.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Nimble Science
Calgary, Alberta, T2L 1Y8
Gwen PhD Duytschaever, PhD, 8664934633, clinical@nimblesci.com
Richdeep Gill, MD
About this study
This is a single-arm interventional clinical study, the primary objective is to assess the changes in the small intestinal (SI) metagenomic profile of in diabetic participants from baseline to midpoint and endpoint in response to the ONS intervention. The study population is Type 2 Diabetes (T2D) participants (n=30) who will ingest an Oral Nutritional Supplement (ONS) .
Read the detailed description
This is a single-arm interventional clinical study, the primary objective is to assess the changes in the small intestinal (SI) metagenomic profile of in diabetic participants from baseline to midpoint and endpoint in response to the ONS intervention. The study population is Type 2 Diabetes (T2D) participants (n=30) who will ingest an Oral Nutritional Supplement (ONS) specifically formulated for T2D participants (Glucerna®). While widely used, and despite a strong scientific rationale for their potential influence on the gut microbiota, the impact of nutritional supplements such as Glucerna® has not yet been tested on the gut microbiome. Understanding their impact on the microbiome can lead to new ways for ONS products to better support metabolic health, and long term glucose sugar control. Given the critical role of the small intestine in T2D, the study utilizes the SIMBA capsule to measure novel changes in the small intestine along with traditional measurements from fecal, saliva and blood.
- Conditions
- Type 2 Diabetes
- Being tested
- Oral nutritional supplement
- Keywords
- oral nutritional supplement, microbiome, small intestine
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral nutritional supplementDietary supplement
Consumption of the oral nutritional supplement
| Study group | Role | What they receive |
|---|---|---|
| Interventional Arm | Experimental | Ingestion of the ONS Receives: Dietary Supplement: Oral nutritional supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome
To assess changes in small intestinal metagenomic profile in Type 2 diabetic participants from baseline to midpoint and endpoint in response to the ONS intervention, as measured using the SIMBA capsule.
Measured: Compared at intervention from baseline, midpoint, to endpoint (completion), an average of 6 weeks
Secondary outcomes (6)
Secondary 1
Assess the change in metagenomic profile between the blood, saliva, and stool, of Type 2 diabetic participants in response response to the ONS intervention from baseline, to midpoint and endpoint using the SIMBA capsule.
Measured: Compared from baseline, midpoint to endpoint (completion), an average of 6 weeks
Secondary 2
Assess the change in metabolomic profile in the saliva blood, stool, and SI of Type 2 diabetic participants in response to the ONS intervention from baseline, to midpoint and endpoint using the SIMBA capsule.
Measured: Compared from baseline, midpoint to endpoint (completion), an average of 6 weeks
Secondary 3
Assess the microbial composition (superimposability of PLS-DA mapping) of the SI from samples collected by the SIMBA capsule
Measured: Compared from baseline, midpoint to endpoint (completion), an average of 6 weeks
Secondary 4
To assess changes in self-reported satiety in response to the ONS which will be measured at three timepoints: baseline, midpoint, and endpoint.
Measured: Compared from baseline, midpoint to endpoint (completion), an average of 6 weeks
Secondary 5
Identify potential metagenomic and metabolomic biomarkers that could predict or correlate with the response to the ONS intervention.
Measured: Compared from baseline, midpoint to endpoint (completion), an average of 6 weeks
Secondary 6
Assess the impact of the ONS intervention on gut function and overall gastrointestinal health, potentially using additional indicators such as gut permeability or inflammatory markers.
Measured: Compared from baseline, midpoint to endpoint (completion), an average of 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study startSep 2025 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nimble Science Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Alberta Obesity Centre
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06704022
- Sponsor's protocol ID
- NIMCSF276
- Status last verified
- Aug 2025
- First submitted
- 20 Nov 2024
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Gut Microbiome Changes Before and After an Oral Nutritional Supplement Intake Using the SIMBA Capsule in Diabetic Participants
- ClinicalTrials.gov ID
- NCT06704022
- Acronym / sponsor ID
- NIMCSF276
- Conditions
- Type 2 Diabetes
- Keywords
- oral nutritional supplement, microbiome, small intestine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Nimble Science Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Alberta Obesity Centre
- Study start
- Sep 2025 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 25 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-arm interventional clinical study, the primary objective is to assess the changes in the small intestinal (SI) metagenomic profile of in diabetic participants from baseline to midpoint and endpoint in response to the ONS intervention. The study population is Type 2 Diabetes (T2D) participants (n=30) who will ingest an Oral Nutritional Supplement (ONS) .
Detailed description
This is a single-arm interventional clinical study, the primary objective is to assess the changes in the small intestinal (SI) metagenomic profile of in diabetic participants from baseline to midpoint and endpoint in response to the ONS intervention. The study population is Type 2 Diabetes (T2D) participants (n=30) who will ingest an Oral Nutritional Supplement (ONS) specifically formulated for T2D participants (Glucerna®). While widely used, and despite a strong scientific rationale for their potential influence on the gut microbiota, the impact of nutritional supplements such as Glucerna® has not yet been tested on the gut microbiome. Understanding their impact on the microbiome can lead to new ways for ONS products to better support metabolic health, and long term glucose sugar control. Given the critical role of the small intestine in T2D, the study utilizes the SIMBA capsule to measure novel changes in the small intestine along with traditional measurements from fecal, saliva and blood.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional Arm | Experimental | Dietary Supplement: Oral nutritional supplementIngestion of the ONS |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Aged 40-65 years old at the inclusion of the study, both female and male subjects.
- 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.
- Has HbA1c ≥ 6.5% and ≤ 9.5% based on a blood sample collected at the Screening Visit, documented within the past month or referred by a medical doctor.
- Normal to overweight (BMI 20-29.9).
- Weight is stable (has maintained current body weight within 3 kg) for the two months prior to the Baseline Visit.
Key exclusion criteria (35 listed)
- Confirmed type 1 diabetes and/or had a history of diabetic ketoacidosis.
- Use of exogenous insulin or GLP1 agonists for glucose control.
- Using diabetes-specific oral nutritional supplements(s), (e.g. Glucerna®, Boost etc.) defined as more than one eating occasion per week within the past 4 weeks (those users who can stop using such products for ≥4 weeks before baseline visit need not be excluded).
- Follows a non-typical eating pattern such as very low carbohydrate diet (e.g., Adkins diet, ketogenic diet, high protein diet).
- Has eating disorder, severe dementia or delirium, history of significant neurological or psychiatric disorder, alcoholism, substance abuse or other conditions that may interfere with study product consumption or compliance with study protocol procedures in the opinion of the investigators.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral nutritional supplementConsumption of the oral nutritional supplement | Dietary supplement | Interventional Arm |
Primary outcome
Primary Outcome
Time frame: Compared at intervention from baseline, midpoint, to endpoint (completion), an average of 6 weeks
To assess changes in small intestinal metagenomic profile in Type 2 diabetic participants from baseline to midpoint and endpoint in response to the ONS intervention, as measured using the SIMBA capsule.
6 secondary outcomes
Secondary 1
Time frame: Compared from baseline, midpoint to endpoint (completion), an average of 6 weeks
Secondary 2
Time frame: Compared from baseline, midpoint to endpoint (completion), an average of 6 weeks
Secondary 3
Time frame: Compared from baseline, midpoint to endpoint (completion), an average of 6 weeks
Secondary 4
Time frame: Compared from baseline, midpoint to endpoint (completion), an average of 6 weeks
Secondary 5
Time frame: Compared from baseline, midpoint to endpoint (completion), an average of 6 weeks
Secondary 6
Time frame: Compared from baseline, midpoint to endpoint (completion), an average of 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oral nutritional supplement in people with Type 2 Diabetes, run by Nimble Science Ltd. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gwen Duytschaever, PhD (8664934633, clinical@nimblesci.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome (time frame: Compared at intervention from baseline, midpoint, to endpoint (completion), an average of 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.