Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
28 participants
INTERVENTIONAL
2024-01-01
2025-10-31
Brief Summary
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Changes in intestinal gas production will also be related to energy expenditure, substrate metabolism, microbial composition and related metabolites in feces, blood and urine.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
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lean normoglycaemic individuals fiber mixture
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
Two day supplementation of a complex fiber mixture
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
lean normoglycaemic placebo
Two day supplementation of 11.43 g (3 x 3.81 g) maltodextrin
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
overweight and/or obesity and prediabetes/insulin fiber mixture
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
Two day supplementation of a complex fiber mixture
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
overweight and/or obesity and prediabetes/insulin resistance placebo
Two day supplementation of 11.43 g (3 x 3.81 g) maltodextrin
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
Interventions
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Two day supplementation of a complex fiber mixture
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 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
Eligibility Criteria
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Inclusion Criteria
* 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)
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)
Exclusion Criteria
* 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)
* 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
30 Years
75 Years
ALL
Yes
Sponsors
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Maastricht University Medical Center
OTHER
Responsible Party
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Locations
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Department of Human Biology, Maastricht University Medical Centre
Maastricht, , Netherlands
Maastricht University Medical Centre
Maastricht, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NL82078.068.22
Identifier Type: -
Identifier Source: org_study_id
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