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) .
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).
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).
Single group
Oral nutritional supplement
Dietary supplementConsumption of the oral nutritional supplement
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.
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.
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.
Secondary 3
Assess the microbial composition (superimposability of PLS-DA mapping) of the SI from samples collected by the SIMBA capsule
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.
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Nimble Science Ltd.
Lead sponsor
Alberta Obesity Centre
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
