NCT07050888

Effect of Inulin Supplementation on Glycaemic Control and Immunological Parameters in Type 1 Diabetes (2024)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The goal is to establish the effect of oral inulin supplementation on continuous glucose monitoring (CGM) metrics and immunological parameters in adults with type 1 diabetes. The investigators will perform a double-blind, randomized, placebo-controlled trial in 2x38 participants to measure effects on CGM metrics, gut microbiome composition, residual beta cell and immunological parameters.

Detailed description

The investigators perform a double-blind, randomized, placebo-controlled trial in 2x38 adults with type 1 diabetes. The participants will be given inulin or placebo once daily in powder, which can be dissolved in water and ingested orally, for 90 days. The main study endpoint is the difference in time in range between the groups between baseline and end-of-study. Secondary endpoints include changes in glycaemic variability, time in tight glycaemic range and hypoglycaemic episodes, gut microbiome composition, changes in residual beta cell function, changes in immunological parameters and validated questionnaires (Quality of Life and gastro-intestinal complaints).

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Inulin (prebiotic, fermentable fiber)	inulin (prebiotic, fermentable fiber)
DIETARY_SUPPLEMENT	Placebo	placebo (matodextrin)

Timeline

• Start date: 2025-05-09
• Primary completion: 2027-04-01
• Completion: 2027-04-01
• First posted: 2025-07-03
• Last updated: 2025-07-03

Locations

2 sites across 1 country: Netherlands