Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inulin | Experimental | prebiotic fermentable fiber inulin |
|
| Placebo | Placebo Comparator | Placebo: Maltodextrin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inulin (prebiotic, fermentable fiber) | Dietary Supplement | inulin (prebiotic, fermentable fiber) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time in range | Difference in time in range between the groups between baseline and end-of-study | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Continuous glucose monitoring | changes in glycaemic variability, time above range, time below range and hypoglycaemic episodes | 90 days |
| Gut microbiome composition | 90 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nordin Hanssen, Principal Investigator | Contact | +31 20-5669111 | n.m.j.hanssen@amsterdamumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Nordin Hanssen, Principal Investigator | Amsterdam UMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diabeter Centrum Amsterdam | Recruiting | Amsterdam | 1066EC | Netherlands |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
2x38 participants will be randomly allocated to inulin or placebo once daily for 90 days.
Not provided
Not provided
The unblinded researcher will provide the study intervention to the blinded investigator in a coded fashion. Both the investigator and the participant are blinded. In case of emergency, an unblinding protocol is activated.
| Placebo |
| Dietary Supplement |
placebo (matodextrin) |
|
| Residual beta cell function | Changes in urinary C-peptide-to-creatinine-ratio (UCPCR) | 90 days |
| Immunological parameters | Plasma cytokines IFN-α, IFN-β, IFN-γ, IL-10 by ELISA | 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. | 90 days |
| Dietary intake | Recorded of 3 days with "Eetmeter". | 90 days |
| Gut inflammation | Fecal IgA and calprotectin in ug/g | 90 days |
| CRP | C-reactive protein (mg/L) | 90 days |
| Leukocyte (differentation) | ×10 9 /L | 90 days |
| Diabetes autoantibodies anti-GAD, anti-IA2, anti-ZnT8 | units per milliliter (U/mL) | 90 days |
| HbA1c | Millimoles of HbA1c per mole of hemoglobin (mmol/mol) | 90 days |
| Quality of life questionnaire | Quality of life SF-12 v2 questionnaire, a higher score reflects higher quality of life | 90 days |
| Amsterdam UMC | Recruiting | Amsterdam | 1105 AZ | Netherlands |
|
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D007444 | Inulin |
| D056692 | Prebiotics |
| ID | Term |
|---|---|
| D013213 | Starch |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005630 | Fructans |
| D011134 | Polysaccharides |
| D004043 | Dietary Fiber |
| D011135 | Polysaccharides, Bacterial |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019587 | Dietary Supplements |
| D019602 | Food and Beverages |
Not provided
Not provided