Using a Complex Carbohydrate Mixture to Steer Fermentation and Improve Metabolism in Adults With … (NCT05354245) | Clinical Trial Compass
CompletedNot Applicable
Using a Complex Carbohydrate Mixture to Steer Fermentation and Improve Metabolism in Adults With Overweight and Prediabetes (DISTAL)
Netherlands44 participantsStarted 2022-09-08
Plain-language summary
The purpose of this study is to investigate the effects of a fibre mixture added to a high-protein diet on metabolic, gut and brain health.
Who can participate
Age range
30 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 30-75 years
* Male/female
* BMI 28-40 kg/m2
* Impaired fasting glucose or glucose tolerance, determined using the following criteria (participant should meet at least one criteria):
* HbA1c 42-47 mmol/mol OR fasting glucose (\>10h fasted) 5.6-6.9 mmol/l OR Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) \>1.85
Exclusion Criteria:
* Diabetes mellitus (type 1 or 2)
* Cardiovascular disease (except hypertension (\<160/100mmHg is allowed), pulmonary disease, kidney disease/failure, liver disease/failure
* Gastrointestinal disease or a history of abdominal surgery (except appendectomy and cholecystectomy)
* Diseases affecting glucose and/or lipid metabolism
* Malignancy (except non-invasive skin cancer)
* Auto-immune disease
* Major mental disorders
* Ongoing (infectious) disease or any disease with a life expectancy ≤5 years
* Substance abuse (nicotine abuse (including e-cigarettes) defined as \>20 cigarettes per day; alcohol abuse defined as ≥8 drinks/week for females and ≥15 drinks/week for males(38); any drugs)
* A change in weight ≥3kg over the last 3 months or plans to lose weight or follow a hypocaloric diet during the study period
* Pre/pro/antibiotic use in the last 3 months or during the study
* Use of medication that influences glucose or fat metabolism and inflammation, such as:
* Use of statins (stable use ≥3 months prior to and during study is allowed)
* Use of antidepressants (stable use ≥3 months prior to and during st…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.