Clinical trial NCT05764200: Acute Microbial Switch
Official title: Acute Microbial Switch Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insulin Sensitivity
Glucose Metabolism Disorders (Including Diabetes Mellitus)
Hyperinsulinism
Keywords: microbiota
insulin sensitivity
fiber
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2023-03-10
Enrollment: 28
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: 24 hour intestinal gas concentrations
timeFrame: after ingestion of the supplement up until 24 hours after supplementation continuously
Secondary outcomes:
measure: 24 hour energy expenditure
timeFrame: after ingestion of the supplement up until 24 hours after supplementation continuously
measure: 24 hour substrate metabolism
timeFrame: after ingestion of the supplement up until 24 hours after supplementation continuously
measure: fecal microbial metabolite concentrations
timeFrame: after ingestion of the supplement and 24 hours after supplementation
measure: Fecal microbiota composition
timeFrame: at baseline and 24 hours after supplementation
measure: 24 hour glucose monitoring
timeFrame: after ingestion of the supplement up until 24 hours after supplementation
measure: circulating blood markers
timeFrame: after ingestion of the supplement at multiple timepoints up until 24 hours after supplementation
measure: Urine metabolites
timeFrame: at baseline up until 24 hours after supplementation
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Department of Human Biology, Maastricht University Medical Centre
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre
Study officials:
References: