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Fiber supplement study reveals gut gas clues to diabetes risk

NCT ID NCT05764200

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a special fiber supplement changes intestinal gas production over 36 hours in 29 adults. Participants included lean healthy people and those with insulin resistance or prediabetes who were overweight. Researchers measured gas levels, energy use, and gut bacteria to better understand how diet affects metabolism.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

29 people

The number who actually took part.

Started

Nov 2023

Finished

Mar 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Department of Human Biology, Maastricht University Medical Centre

    Maastricht, 6200MD, Netherlands

  • Maastricht University Medical Centre

    Maastricht, Netherlands

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Other studies related to the condition(s) this trial covers.