Testing a fiber mixture's effect on gut gas production and metabolism

Acute Microbial Switch Study

This study is testing if a special mix of fibers can change gas production in the gut and help people with different metabolic conditions feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 28 (estimated)
• Ages: 30 Years to 75 Years
• Sex: All
• Sponsor: Maastricht University Medical Center (Academic / other)
• Locations: 2 sites (Maastricht and 1 other locations)
• Trial ID: NCT05764200 on ClinicalTrials.gov

What this trial studies

This project investigates the impact of a complex fiber mixture on intestinal gas production over a 36-hour period in both lean individuals and those with insulin resistance or prediabetes. Participants will receive either the fiber supplement or a placebo, and changes in gas production will be correlated with energy expenditure, substrate metabolism, and microbial composition. The study aims to provide insights into how dietary fibers may influence metabolic health through gut microbiota interactions.

Who should consider this trial

Good fit: Ideal candidates include lean individuals with normal glucose levels and those with overweight or obesity who have insulin resistance or prediabetes.

Not a fit: Patients with type 2 diabetes or significant gastrointestinal diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to dietary interventions that improve insulin sensitivity and glucose metabolism in at-risk populations.

How similar studies have performed: While the specific approach of measuring gas production in relation to fiber supplementation is novel, similar studies have shown promising results in improving metabolic health through dietary interventions.

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

Where this trial is running

Maastricht and 1 other locations

• Department of Human Biology, Maastricht University Medical Centre — Maastricht, Netherlands (Recruiting)
• Maastricht University Medical Centre — Maastricht, Netherlands (Recruiting)

Study contacts

• Study coordinator: Gillian Larik, Msc

Conditions Insulin Sensitivity; Glucose Metabolism Disorders; Hyperinsulinism; microbiota; insulin sensitivity; fiber