An interventional study of Two day supplementation of a complex fiber mixture and Placebo supplementation in Insulin Sensitivity, Glucose Metabolism Disorders (Including Diabetes Mellitus) and Hyperinsulinism, sponsored by Maastricht University Medical Center. Completed at 2 sites in Netherlands. Open to participants aged 30 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-11.
Sponsored by Maastricht University Medical Center · Not applicable, Interventional, and Basic science
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.
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.
2,969 studies on the registry are indexed under Insulin Resistance; 338 are open to participants now.
This study's enrollment of 29 is below the median of 40 across 2,369 interventional studies indexed under Insulin Resistance.
Browse Insulin Resistance studies →Maastricht University Medical Center is the lead sponsor of 853 studies on the registry; 114 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Individuals with overweight/obesity and prediabetes/insulin resistance:
For both subject groups:
Exclusion Criteria:
Abuse of products;
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Dietary Supplement: Two day supplementation of a complex fiber mixture
Two day supplementation of 11.43 g (3 x 3.81 g) maltodextrin
Dietary Supplement: Placebo supplementation
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
Dietary Supplement: Two day supplementation of a complex fiber mixture
Two day supplementation of 11.43 g (3 x 3.81 g) maltodextrin
Dietary Supplement: Placebo supplementation
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
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
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)
Time frame: after ingestion of the supplement up until 24 hours after supplementation continuously
24 hour energy expenditure
changes in 24 hour energy expenditure will be measured in a respiration chamber
Time frame: 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)
Time frame: 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
Time frame: after ingestion of the supplement and 24 hours after supplementation
Fecal microbiota composition
Faecal microbiota composition will be assessed via16S rRNA gene sequencing
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: at baseline up until 24 hours after supplementation
Plan to share: Undecided — anonymized data may be shared with other researchers for meta-analyses etc., however personalized data names etc. will not be made available
No publications or documents are linked to this record.
Ran from Nov 2023 to primary completion in Mar 2025, 16 months.
Of 714 non-industry interventional studies with no phase under Insulin Resistance, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's 16 months is below that.
Counting every sponsor, half of 754 studies reached it within 21 months; a quarter within 9 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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