Type 1 Diabetes MellitusINCREASENCT07050888
Effect of Inulin Supplementation on Glycaemic Control and Immunological Parameters in Type 1 Diabetes (2024)
A study testing Inulin (prebiotic, fermentable fiber) in people with Type 1 Diabetes Mellitus, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 2 sites in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Inulin (prebiotic, fermentable fiber)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 2 sitesNetherlands
- Study dates
- 9 May 2025to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands2 sites, 2 recruiting
- Recruiting
Diabeter Centrum Amsterdam
Amsterdam, 1066EC
Nordin Hanssen, Prinicpal Investigator, 020 566 9111, n.m.j.hanssen@amsterdamumc.nl
- Recruiting
Amsterdam UMC
Amsterdam, 1105 AZ
Max Nieuwdorp, Prof dr., 020 566 9111, m.nieuwdorp@amsterdamumc.nl
About this study
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.
Read the 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
- Being tested
- Inulin (prebiotic, fermentable fiber), Placebo
- Keywords
- type 1 diabetes mellitus, inulin, gut microbiome, prebiotics, CGM metrics, immunological parameters
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inulin (prebiotic, fermentable fiber)Dietary supplement
inulin (prebiotic, fermentable fiber)
PlaceboDietary supplement
placebo (matodextrin)
| Study group | Role | What they receive |
|---|---|---|
| Inulin | Experimental | prebiotic fermentable fiber inulin Receives: Dietary Supplement: Inulin (prebiotic, fermentable fiber) |
| Placebo | Placebo comparator | Placebo: Maltodextrin Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in range
Difference in time in range between the groups between baseline and end-of-study
Measured: 90 days
Secondary outcomes (12)
Continuous glucose monitoring
changes in glycaemic variability, time above range, time below range and hypoglycaemic episodes
Measured: 90 days
Gut microbiome composition
Measured: 90 days
Residual beta cell function
Changes in urinary C-peptide-to-creatinine-ratio (UCPCR)
Measured: 90 days
Immunological parameters
Plasma cytokines IFN-α, IFN-β, IFN-γ, IL-10 by ELISA
Measured: 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.
Measured: 90 days
Dietary intake
Recorded of 3 days with "Eetmeter".
Measured: 90 days
Gut inflammation
Fecal IgA and calprotectin in ug/g
Measured: 90 days
CRP
C-reactive protein (mg/L)
Measured: 90 days
Leukocyte (differentation)
×10 9 /L
Measured: 90 days
Diabetes autoantibodies anti-GAD, anti-IA2, anti-ZnT8
units per milliliter (U/mL)
Measured: 90 days
HbA1c
Millimoles of HbA1c per mole of hemoglobin (mmol/mol)
Measured: 90 days
Quality of life questionnaire
Quality of life SF-12 v2 questionnaire, a higher score reflects higher quality of life
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start9 May 2025
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2x38 participants will be randomly allocated to inulin or placebo once daily for 90 days.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Max Nieuwdorp, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Nordin Hanssen, Principal Investigator, Principal investigator, Amsterdam UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07050888
- Sponsor's protocol ID
- 2024.1028
- Acronym
- INCREASE
- Status last verified
- Jun 2025
- First submitted
- 6 Jun 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Inulin Supplementation on Glycaemic Control and Immunological Parameters in Type 1 Diabetes (2024)
- ClinicalTrials.gov ID
- NCT07050888
- Acronym / sponsor ID
- INCREASE / 2024.1028
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- type 1 diabetes mellitus, inulin, gut microbiome, prebiotics, CGM metrics, immunological parameters
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 9 May 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 3 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- 2x38 participants will be randomly allocated to inulin or placebo once daily for 90 days.
| Arm | Type | Receives |
|---|---|---|
| Inulin | Experimental | Dietary Supplement: Inulin (prebiotic, fermentable fiber)prebiotic fermentable fiber inulin |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo: Maltodextrin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inulin (prebiotic, fermentable fiber)inulin (prebiotic, fermentable fiber) | Dietary supplement | Inulin |
| Placeboplacebo (matodextrin) | Dietary supplement | Placebo |
Primary outcome
Time in range
Time frame: 90 days
Difference in time in range between the groups between baseline and end-of-study
12 secondary outcomes
Continuous glucose monitoring
Time frame: 90 days
Gut microbiome composition
Time frame: 90 days
Residual beta cell function
Time frame: 90 days
Immunological parameters
Time frame: 90 days
Gastrointestinal Symptom Rating Scale (GSRS)
Time frame: 90 days
Dietary intake
Time frame: 90 days
Gut inflammation
Time frame: 90 days
CRP
Time frame: 90 days
Leukocyte (differentation)
Time frame: 90 days
Diabetes autoantibodies anti-GAD, anti-IA2, anti-ZnT8
Time frame: 90 days
HbA1c
Time frame: 90 days
Quality of life questionnaire
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Type 1 Diabetes Mellitus
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nordin Hanssen, Principal Investigator principal investigator
Amsterdam UMC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inulin (prebiotic, fermentable fiber) in people with Type 1 Diabetes Mellitus, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nordin Hanssen, Principal Investigator (+31 20-5669111, n.m.j.hanssen@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in range (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.