An interventional study of Inulin (prebiotic, fermentable fiber) and Placebo in Type 1 Diabetes Mellitus, sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). Recruiting at 2 sites in Netherlands. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-07-03.
Sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Not applicable, Interventional, and Treatment
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.
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).
3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.
This study's planned enrollment of 76 is above the median of 40 across 2,649 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) is the lead sponsor of 512 studies on the registry; 178 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
prebiotic fermentable fiber inulin
Dietary Supplement: Inulin (prebiotic, fermentable fiber)
Placebo: Maltodextrin
Dietary Supplement: Placebo
inulin (prebiotic, fermentable fiber)
placebo (matodextrin)
Time in range
Difference in time in range between the groups between baseline and end-of-study
Time frame: 90 days
Continuous glucose monitoring
changes in glycaemic variability, time above range, time below range and hypoglycaemic episodes
Time frame: 90 days
Gut microbiome composition
Time frame: 90 days
Residual beta cell function
Changes in urinary C-peptide-to-creatinine-ratio (UCPCR)
Time frame: 90 days
Immunological parameters
Plasma cytokines IFN-α, IFN-β, IFN-γ, IL-10 by ELISA
Time frame: 90 days
Gastrointestinal Symptom Rating Scale (GSRS)
Questionnaire. The minimum and maximum score are 15 and 105 points respectively, and a higher score in the scale reflects more gastro-intestinal complaints.
Time frame: 90 days
Dietary intake
Recorded of 3 days with "Eetmeter".
Time frame: 90 days
Gut inflammation
Fecal IgA and calprotectin in ug/g
Time frame: 90 days
CRP
C-reactive protein (mg/L)
Time frame: 90 days
Leukocyte (differentation)
×10 9 /L
Time frame: 90 days
Diabetes autoantibodies anti-GAD, anti-IA2, anti-ZnT8
units per milliliter (U/mL)
Time frame: 90 days
HbA1c
Millimoles of HbA1c per mole of hemoglobin (mmol/mol)
Time frame: 90 days
Quality of life questionnaire
Quality of life SF-12 v2 questionnaire, a higher score reflects higher quality of life
Time frame: 90 days
Plan to share: No
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)