NCT06704022

Assessing Gut Microbiome Changes Before and After an Oral Nutritional Supplement Intake Using the SIMBA Capsule in Diabetic Participants

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Nimble Science Ltd. · Industry
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Oral nutritional supplement	Consumption of the oral nutritional supplement

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2024-11-25
• Last updated: 2025-08-11

Locations

1 site across 1 country: Canada