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Completed

NCT Number: NCT05764200

Acute Microbial Switch

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.

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Key information

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Human Biology, Maastricht University Medical Centre, Maastricht, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Two day supplementation of a complex fiber mixture

Dietary Supplement

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

Dietary Supplement

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

Primary outcomes

  1. 24 hour intestinal gas concentrations

    Time frame: 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 outcomes

  1. 24 hour energy expenditure

    Time frame: 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

  2. 24 hour substrate metabolism

    Time frame: 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)

  3. fecal microbial metabolite concentrations

    Time frame: after ingestion of the supplement and 24 hours after supplementation

    the concentrations of fecal SCFA and BCFAs will be measured

  4. Fecal microbiota composition

    Time frame: at baseline and 24 hours after supplementation

    Faecal microbiota composition will be assessed via16S rRNA gene sequencing

  5. 24 hour glucose monitoring

    Time frame: 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

  6. circulating blood markers

    Time frame: 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

  7. Urine metabolites

    Time frame: at baseline up until 24 hours after supplementation

    urinary concentrations of phenolic compounds, p-cresol and nitrogen will be measured

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

Acute Microbial Switch Study

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 10, 2023
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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