Inulin and the Gut Microbiota in Healthy Adults (NCT05399316) | Clinical Trial Compass
CompletedNot Applicable
Inulin and the Gut Microbiota in Healthy Adults
Germany24 participantsStarted 2022-06-15
Plain-language summary
In this study the effects of a fibre dietary supplement on the gut microbiome in healthy adults will be investigated. For this purpose, a 14-day dietary supplementation with inulin or placebo (maltodextrin) will be carried out in healthy adults. The main objective of the study is to investigate inulin-induced changes in gut bacterial composition, bacterial gene expression, bacterial metabolite production and associated immune system changes.
Who can participate
Age range
20 Years – 60 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:
* Men and women in a 1:1 ratio
* Age 20 - 60 years
* Body Mass Index 18.5 - 34.9 kg/m2
Exclusion Criteria:
* Arterial hypertension, diabetes mellitus, known cardiovascular disease requiring treatment (e.g. coronary heart disease, stroke).
* Known end-organ damage to the brain, heart or kidneys
* Chronic kidney disease, need for dialysis
* Diseases or functional disorders that, in the opinion of the study doctor, preclude participation in the study
* Acute infections
* Malnutrition
* Antibiotics in the previous 4 weeks
* Regular consumption of probiotics or prebiotics
* Allergies
* Change in bodyweight of more than 2 kg in the previous 3 months
* Inability to uderstand the studie aims and study procedures
* Drug or alcohol abuse
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.