Insulin SensitivityNCT05764200
Acute Microbial Switch
A study testing Two day supplementation of a complex fiber mixture in people with Insulin Sensitivity and Glucose Metabolism Disorders (Including Diabetes Mellitus), run by Maastricht University Medical Center at 2 sites in Netherlands.
Trial summary
In this project the investigators will test if it is possible to measure changes in intestinal gas production after supplementation of a complex fiber mixture over a 36 hour period in both lean normoglycemic individuals and individuals with insulin resistance and/or prediabetes with overweight when compared with a… Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Sensitivity, Glucose Metabolism Disorders (Including Diabetes Mellitus), Hyperinsulinism
- What is being tested?
- Two day supplementation of a complex fiber mixture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 2 sitesNetherlands
- Study dates
- 24 Nov 2023to 27 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Lean normoglycemic individuals:
- Lean (BMI ≥ 18.5 kg/m2 and ≤ 24.9 kg/m2 );
- Normal fasting glucose (plasma glucose < 5.6 mmol/L) and a HOMA-IR< 2.2
- Individuals with overweight/obesity and prediabetes/insulin resistance:
- Overweight/obesity (BMI ≥ 28 kg/m2 and ≤ 40 kg/m2 );
- insulin resistance (HOMA-IR>2.2) and/or impaired fasting glucose (IFG: plasma glucose ≥ 5.6 mmol/l)
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- For both subject groups:
- Aged 30 - 75 years;
- Normal blood pressure (systolic blood pressure 100-150mmHg, diastolic blood pressure 60-100 mmHg);
- Weight stable for at least 3 months (± 2 kg)
Who cannot join
- T2DM (defined as fasting plasma glucose ≥ 7.0 mmol/L)
- Gastroenterological diseases
- Abdominal surgery affecting the GI tract;
- Cardiovascular diseases, cancer, liver or kidney malfunction, disease with a life expectancy shorter than five years;
- Abuse of products;
- Alcohol (> 15 standard units per week)
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- Drugs
- Excessive nicotine use defined as >20 cigarettes per day;
- Plans to lose weight or following of a hypocaloric diet
- Regular supplementation of pre- or probiotic products, use of pre- or probiotics three months prior to the start of the study;
- Intensive exercise training more than three hours a week;
- Use of most medications that influence glucose or fat metabolism, like some lipid lowering-drugs (e.g., PPAR γ or PPARα (fibrates) agonists), glucose-lowering agents (including all sulfonylureas, biguanides, α-glucosidase inhibitors, thiazolidinediones, repaglinide, nateglinide and insulin), inflammation (e.g., anti-inflammatory* or immunosuppressive drugs) and anti-oxidants;
- Regular use of laxatives;
- Use of antibiotics in the last three months (antibiotics use can alter substantially the gut microbiota composition).
- Veganism
- Lactose intolerance
- For women: pregnancy or lactation
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Department of Human Biology, Maastricht University Medical Centre
Maastricht, 6200MD
Maastricht University Medical Centre
Maastricht
About this study
Official title: Acute Microbial Switch Study
In this project the investigators will test if it is possible to measure changes in intestinal gas production after supplementation of a complex fiber mixture over a 36 hour period in both lean normoglycemic individuals and individuals with insulin resistance and/or prediabetes with overweight when compared with a placebo
Changes in intestinal gas production will also be related to energy expenditure, substrate metabolism, microbial composition and related metabolites in feces, blood and urine.
Read the detailed description
In this project the investigators aim to test whether it is possible to precisely measure the changes in fermentation gas patterns after supplementation of a complex fibre mixture over a 36-hour period in both lean normoglycemic and individuals with insulin resistance and/or prediabetes with overweight when compared with a placebo. Additionally, the investigators will investigate whether changes in fermentation patterns will be directly related to changes in carbohydrate and fat oxidation and to microbial composition or related metabolites and hormones in blood, faeces, and urine.
- Conditions
- Insulin Sensitivity, Glucose Metabolism Disorders (Including Diabetes Mellitus), Hyperinsulinism
- Being tested
- Two day supplementation of a complex fiber mixture, Placebo supplementation
- Keywords
- microbiota, insulin sensitivity, fiber
- Medical subject headings
- Insulin Resistance, Glucose Metabolism Disorders, Hyperinsulinism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two day supplementation of a complex fiber mixtureDietary supplement
Participants will undergo a two day supplementation of a complex fiber supplement vs. placebo with a two-week washout period between the two interventions in a randomized order
Placebo supplementationDietary supplement
Participants will undergo a two day supplementation of a complex fiber supplement vs. placebo with a two-week washout period between the two interventions in a randomized order
| Study group | Role | What they receive |
|---|---|---|
| lean normoglycaemic individuals fiber mixture | Active comparator | Two day supplementation of 12 g (3 x 4 g) of the dietary fiber inulin in combination with 9.375 g (3 x 3.125 g (80% resistant starch (3 x 2.5 g)) granular potato starch Receives: Dietary Supplement: Two day supplementation of a complex fiber mixture |
| lean normoglycaemic placebo | Placebo comparator | Two day supplementation of 11.43 g (3 x 3.81 g) maltodextrin Receives: Dietary Supplement: Placebo supplementation |
| overweight and/or obesity and prediabetes/insulin fiber mixture | Active comparator | Two day supplementation of 12 g (3 x 4 g) of the dietary fiber inulin in combination with 9.375 g (3 x 3.125 g (80% resistant starch (3 x 2.5 g)) granular potato starch Receives: Dietary Supplement: Two day supplementation of a complex fiber mixture |
| overweight and/or obesity and prediabetes/insulin resistance placebo | Placebo comparator | Two day supplementation of 11.43 g (3 x 3.81 g) maltodextrin Receives: Dietary Supplement: Placebo supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
24 hour intestinal gas concentrations
changes in intestinal gas excretion (methane, hydrogen or hydrogen sulphide will be measured using gas sensors in a modified respiration chamber)
Measured: after ingestion of the supplement up until 24 hours after supplementation continuously
Secondary outcomes (7)
24 hour energy expenditure
changes in 24 hour energy expenditure will be measured in a respiration chamber
Measured: after ingestion of the supplement up until 24 hours after supplementation continuously
24 hour substrate metabolism
changes in 24 hour substrate metabolism will be measured in a respiration chamber (fat and carbohydrate oxidation)
Measured: after ingestion of the supplement up until 24 hours after supplementation continuously
fecal microbial metabolite concentrations
the concentrations of fecal SCFA and BCFAs will be measured
Measured: after ingestion of the supplement and 24 hours after supplementation
Fecal microbiota composition
Faecal microbiota composition will be assessed via16S rRNA gene sequencing
Measured: at baseline and 24 hours after supplementation
24 hour glucose monitoring
24 hour glucoses concentrations will be measured using a wearable monitor during each testday
Measured: after ingestion of the supplement up until 24 hours after supplementation
circulating blood markers
plasma blood glucose, insulin, GLP-1, glucagon, PYY, triglycerides, FFA, SCFA and BCFA
Measured: after ingestion of the supplement at multiple timepoints up until 24 hours after supplementation
Urine metabolites
urinary concentrations of phenolic compounds, p-cresol and nitrogen will be measured
Measured: at baseline up until 24 hours after supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start24 Nov 2023
- Primary completion27 Mar 2025
- Study completion27 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin SensitivityStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05764200
- Sponsor's protocol ID
- NL82078.068.22
- Status last verified
- Jun 2026
- First submitted
- 17 Feb 2023
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: anonymized data may be shared with other researchers for meta-analyses etc., however personalized data names etc. will not be made available
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Microbial Switch Study
- ClinicalTrials.gov ID
- NCT05764200
- Acronym / sponsor ID
- NL82078.068.22
- Conditions
- Insulin Sensitivity, Glucose Metabolism Disorders (Including Diabetes Mellitus), Hyperinsulinism
- Keywords
- microbiota, insulin sensitivity, fiber
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 24 Nov 2023 (actual)
- Primary completion
- 27 Mar 2025 (actual)
- Study completion
- 27 Mar 2025 (actual)
- First posted
- 10 Mar 2023 (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.
In this project the investigators will test if it is possible to measure changes in intestinal gas production after supplementation of a complex fiber mixture over a 36 hour period in both lean normoglycemic individuals and individuals with insulin resistance and/or prediabetes with overweight when compared with a placebo
Changes in intestinal gas production will also be related to energy expenditure, substrate metabolism, microbial composition and related metabolites in feces, blood and urine.
Detailed description
In this project the investigators aim to test whether it is possible to precisely measure the changes in fermentation gas patterns after supplementation of a complex fibre mixture over a 36-hour period in both lean normoglycemic and individuals with insulin resistance and/or prediabetes with overweight when compared with a placebo. Additionally, the investigators will investigate whether changes in fermentation patterns will be directly related to changes in carbohydrate and fat oxidation and to microbial composition or related metabolites and hormones in blood, faeces, and urine.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| lean normoglycaemic individuals fiber mixture | Active comparator | Dietary Supplement: Two day supplementation of a complex fiber mixtureTwo day supplementation of 12 g (3 x 4 g) of the dietary fiber inulin in combination with 9.375 g (3 x 3.125 g (80% resistant starch (3 x 2.5 g)) granular potato starch |
| lean normoglycaemic placebo | Placebo comparator | Dietary Supplement: Placebo supplementationTwo day supplementation of 11.43 g (3 x 3.81 g) maltodextrin |
| overweight and/or obesity and prediabetes/insulin fiber mixture | Active comparator | Dietary Supplement: Two day supplementation of a complex fiber mixtureTwo day supplementation of 12 g (3 x 4 g) of the dietary fiber inulin in combination with 9.375 g (3 x 3.125 g (80% resistant starch (3 x 2.5 g)) granular potato starch |
| overweight and/or obesity and prediabetes/insulin resistance placebo | Placebo comparator | Dietary Supplement: Placebo supplementationTwo day supplementation of 11.43 g (3 x 3.81 g) maltodextrin |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Lean normoglycemic individuals:
- Lean (BMI ≥ 18.5 kg/m2 and ≤ 24.9 kg/m2 );
- Normal fasting glucose (plasma glucose < 5.6 mmol/L) and a HOMA-IR< 2.2
- Overweight/obesity (BMI ≥ 28 kg/m2 and ≤ 40 kg/m2 );
- insulin resistance (HOMA-IR>2.2) and/or impaired fasting glucose (IFG: plasma glucose ≥ 5.6 mmol/l)
Key exclusion criteria (17 listed)
- T2DM (defined as fasting plasma glucose ≥ 7.0 mmol/L)
- Gastroenterological diseases
- Abdominal surgery affecting the GI tract;
- Cardiovascular diseases, cancer, liver or kidney malfunction, disease with a life expectancy shorter than five years;
- Abuse of products;
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 |
|---|---|---|
| Two day supplementation of a complex fiber mixtureParticipants will undergo a two day supplementation of a complex fiber supplement vs. placebo with a two-week washout period between the two interventions in a randomized order | Dietary supplement | lean normoglycaemic individuals fiber mixture, overweight and/or obesity and prediabetes/insulin fiber mixture |
| Placebo supplementationParticipants will undergo a two day supplementation of a complex fiber supplement vs. placebo with a two-week washout period between the two interventions in a randomized order | Dietary supplement | lean normoglycaemic placebo, overweight and/or obesity and prediabetes/insulin resistance placebo |
Primary outcome
24 hour intestinal gas concentrations
Time frame: after ingestion of the supplement up until 24 hours after supplementation continuously
changes in intestinal gas excretion (methane, hydrogen or hydrogen sulphide will be measured using gas sensors in a modified respiration chamber)
7 secondary outcomes
24 hour energy expenditure
Time frame: after ingestion of the supplement up until 24 hours after supplementation continuously
24 hour substrate metabolism
Time frame: after ingestion of the supplement up until 24 hours after supplementation continuously
fecal microbial metabolite concentrations
Time frame: after ingestion of the supplement and 24 hours after supplementation
Fecal microbiota composition
Time frame: at baseline and 24 hours after supplementation
24 hour glucose monitoring
Time frame: after ingestion of the supplement up until 24 hours after supplementation
circulating blood markers
Time frame: after ingestion of the supplement at multiple timepoints up until 24 hours after supplementation
Urine metabolites
Time frame: at baseline up until 24 hours after supplementation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: Undecided. anonymized data may be shared with other researchers for meta-analyses etc., however personalized data names etc. will not be made available
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Two day supplementation of a complex fiber mixture in people with Insulin Sensitivity and Glucose Metabolism Disorders (Including Diabetes Mellitus), run by Maastricht University Medical Center 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 10 inclusion and 17 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: finished, as of the sponsor's last update on 11 Jun 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24 hour intestinal gas concentrations (time frame: after ingestion of the supplement up until 24 hours after supplementation continuously). 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 11 Jun 2026.