Inulin for blood sugar control and immune markers in adults with type 1 diabetes
Effect of Inulin Supplementation on Glycaemic Control and Immunological Parameters in Type 1 Diabetes (2024)
This 90-day trial will test whether taking daily inulin powder improves continuous glucose monitoring measures and immune markers in adults with type 1 diabetes who have less than 80% time in range.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 76 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Locations | 2 sites (Amsterdam and 1 other locations) |
| Trial ID | NCT07050888 on ClinicalTrials.gov |
What this trial studies
This is a double-blind, randomized, placebo-controlled trial enrolling 76 adults with type 1 diabetes who are randomized 1:1 to daily inulin powder or placebo for 90 days. The primary endpoint is change in time in range measured by continuous glucose monitoring from baseline to end of study, with secondary endpoints including glycaemic variability, time in tight range, hypoglycaemic episodes, gut microbiome composition, residual beta cell function, immunological parameters, and patient-reported quality of life and gastrointestinal symptoms. Participants provide stool and urine samples and undergo laboratory testing at baseline and end-of-study; recent antibiotic use or ongoing fibre supplementation are exclusion criteria. The trial is conducted at Amsterdam UMC/Diabeter in Amsterdam and uses validated CGM metrics and microbiome analyses to link dietary prebiotic exposure with metabolic and immune outcomes.
Who should consider this trial
Good fit: Adults with type 1 diabetes who have under 80% time in range, can attend visits in Amsterdam, are willing to take a daily inulin powder and provide stool/urine samples, and have not used antibiotics or fibre supplements recently are ideal candidates.
Not a fit: People with recent antibiotic use, active inflammatory bowel disease, absence of a large bowel (e.g., colostomy), current fibre supplementation, or those already maintaining ≥80% time in range are unlikely to gain benefit from this intervention.
Why it matters
Potential benefit: If successful, daily inulin could increase time in range and reduce glucose variability while shifting the gut microbiome and immune markers in a beneficial direction.
How similar studies have performed: Small human and animal studies suggest prebiotics like inulin can modify the microbiome and affect metabolic markers, but randomized, placebo-controlled evidence specifically in adults with type 1 diabetes is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * A diagnosis of type 1 diabetes, as made by their primary clinician * A time in range of \<80% in the last four weeks before screening Exclusion Criteria: * Use of any fibre supplementation (within the last month before screening or ongoing) * Use of antibiotics in the lasts three months before screening or during study period * Active infection during the study visit * Inability or unwillingness to donate feces or urine. * Illicit drug use (e.g. MDMA/amphetamine/cocaine/heroin/GHB) in the past three months or use during the study period. * Inability or unwillingness to provide informed consent. * Absence of a large bowel (ie colostomy) * Active inflammatory bowel disease
Where this trial is running
Amsterdam and 1 other locations
- Diabeter Centrum Amsterdam — Amsterdam, Netherlands (Recruiting)
- Amsterdam UMC — Amsterdam, Netherlands (Recruiting)
Study contacts
- Principal investigator: Nordin Hanssen, Principal Investigator — Amsterdam UMC
- Study coordinator: Nordin Hanssen, Principal Investigator
- Email: n.m.j.hanssen@amsterdamumc.nl
- Phone: +31 20-5669111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.