Insulin Sensitivity Clinical Trial
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.
Status | Not yet recruiting |
Enrollment | 28 |
Est. completion date | October 31, 2025 |
Est. primary completion date | October 31, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 30 Years to 75 Years |
Eligibility | 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 ? or PPARa (fibrates) agonists), glucose-lowering agents (including all sulfonylureas, biguanides, a-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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | Department of Human Biology, Maastricht University Medical Centre | Maastricht | |
Netherlands | Maastricht University Medical Centre | Maastricht |
Lead Sponsor | Collaborator |
---|---|
Maastricht University Medical Center |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | after ingestion of the supplement up until 24 hours after supplementation continuously | |
Secondary | 24 hour energy expenditure | changes in 24 hour energy expenditure will be measured in a respiration chamber | after ingestion of the supplement up until 24 hours after supplementation continuously | |
Secondary | 24 hour substrate metabolism | changes in 24 hour substrate metabolism will be measured in a respiration chamber (fat and carbohydrate oxidation) | after ingestion of the supplement up until 24 hours after supplementation continuously | |
Secondary | fecal microbial metabolite concentrations | the concentrations of fecal SCFA and BCFAs will be measured | after ingestion of the supplement and 24 hours after supplementation | |
Secondary | Fecal microbiota composition | Faecal microbiota composition will be assessed via16S rRNA gene sequencing | at baseline and 24 hours after supplementation | |
Secondary | 24 hour glucose monitoring | 24 hour glucoses concentrations will be measured using a wearable monitor during each testday | after ingestion of the supplement up until 24 hours after supplementation | |
Secondary | circulating blood markers | plasma blood glucose, insulin, GLP-1, glucagon, PYY, triglycerides, FFA, SCFA and BCFA | after ingestion of the supplement at multiple timepoints up until 24 hours after supplementation | |
Secondary | Urine metabolites | urinary concentrations of phenolic compounds, p-cresol and nitrogen will be measured | at baseline up until 24 hours after supplementation |
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