Effect of inulin supplementation on glycaemic control and immunological parameters in type 1 diabetes

Effect of inulin supplementation on glycaemic control and immunological parameters in type 1 diabetes - INCREASE

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON57582

Enrollment

Registered

2025-03-31

Start date

2025-05-09

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 diabetes mellitus

Interventions

• Group 1. The people in this group will receive 10 grams of inulin per day in&nbsp

a sachet for 12 weeks. • Group 2. The people in this group will receive a placebo that looks the same&nbsp

as the active medication for 12 weeks. This is maltodextrin, a safe substance&nbsp

commonly used as a placebo

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Males or females, age 18-70 years  - 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

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

Design outcomes

Primary

Measure	Time frame
To establish the effect of once daily inulin supplementation on time in range in adults with type 1 diabetes.	—

Secondary

Measure	Time frame
To establish the effect of once daily inulin supplementation on: - Other CGM metrics (time above range, time below range and glucose variability) - Quality of Life and abdominal complaints, as assessed by validated questionnaires - Number of hypglycaemic episodes (assessed by CGM) - Gut inflammation (fecal calprotectin, IgA) - Systemic inflammation/autoimmunity (using a cytokine panel, CRP, leucocytes and autoantibodies) - Gut microbiome composition (using shotgun metagenomic sequencing) - Residual beta cell function (post meal urine C-peptide/creatinine levels) - Insulin resistance (insulin dose/kg, HbA1c, quantified with formula of Januszewski et al (17).	—

Measure

Time frame

To establish the effect of once daily inulin supplementation on: - Other CGM metrics (time above range, time below range and glucose variability) - Quality of Life and abdominal complaints, as assessed by validated questionnaires - Number of hypglycaemic episodes (assessed by CGM) - Gut inflammation (fecal calprotectin, IgA) - Systemic inflammation/autoimmunity (using a cytokine panel, CRP, leucocytes and autoantibodies) - Gut microbiome composition (using shotgun metagenomic sequencing) - Residual beta cell function (post meal urine C-peptide/creatinine levels) - Insulin resistance (insulin dose/kg, HbA1c, quantified with formula of Januszewski et al (17).

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jun 11, 2026