Glucose Metabolism Disorders (Including Diabetes Mellitus), Hyperinsulinism, Insulin Sensitivity
Conditions
Keywords
microbiota, insulin sensitivity, fiber
Brief 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 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.
Interventions
DIETARY_SUPPLEMENTTwo 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
DIETARY_SUPPLEMENTPlacebo 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
Sponsors
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Masking description
double-blinded
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* 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) 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
* 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) * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 24 hour intestinal gas concentrations | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 24 hour energy expenditure | after ingestion of the supplement up until 24 hours after supplementation continuously | changes in 24 hour energy expenditure will be measured in a respiration chamber |
| 24 hour substrate metabolism | after ingestion of the supplement up until 24 hours after supplementation continuously | changes in 24 hour substrate metabolism will be measured in a respiration chamber (fat and carbohydrate oxidation) |
| fecal microbial metabolite concentrations | after ingestion of the supplement and 24 hours after supplementation | the concentrations of fecal SCFA and BCFAs will be measured |
| Fecal microbiota composition | at baseline and 24 hours after supplementation | Faecal microbiota composition will be assessed via16S rRNA gene sequencing |
| 24 hour glucose monitoring | after ingestion of the supplement up until 24 hours after supplementation | 24 hour glucoses concentrations will be measured using a wearable monitor during each testday |
| circulating blood markers | after ingestion of the supplement at multiple timepoints up until 24 hours after supplementation | plasma blood glucose, insulin, GLP-1, glucagon, PYY, triglycerides, FFA, SCFA and BCFA |
| Urine metabolites | at baseline up until 24 hours after supplementation | urinary concentrations of phenolic compounds, p-cresol and nitrogen will be measured |
Countries
Netherlands
Outcome results
None listed