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) .
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Consumption of the oral nutritional supplement
Nimble Science
Calgary, Alberta, Canada
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.
Time frame: Compared at intervention from baseline, midpoint, to endpoint (completion), an average of 6 weeks
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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: Compared from baseline, midpoint to endpoint (completion), an average of 6 weeks