The Effects of Chicory Root-derived Prebiotic on Mood and Stress Responsiveness in Healthy Adults… (NCT07058324) | Clinical Trial Compass
RecruitingNot Applicable
The Effects of Chicory Root-derived Prebiotic on Mood and Stress Responsiveness in Healthy Adults With Mild to Moderate Levels of Stress and Anxiety
Germany204 participantsStarted 2025-06-02
Plain-language summary
Emerging evidence from preclinical research suggests that prebiotic fibres may play a beneficial role in supporting mental health through modulation of the gut-brain axis-a complex communication network linking the gastrointestinal tract and the central nervous system. Chicory root-derived prebiotic fibre, already well-established for its positive effects on glycaemic control and bowel regularity, has recently shown promise in this context. The present study aims to investigate the mental health benefits of chicory root fibre in a larger and more diverse population, thereby contributing to the growing body of evidence supporting nutritional strategies for mental well-being.
Who can participate
Age range
18 Years – 70 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.
. GAD total score ≥ 5 and ≤ 14 indicating mild to moderate anxiety.
. Male or female aged ≥18 and ≤ 70 years at the time of screening.
. Body-Mass-Index (BMI) ≥ 18.5 and ≤ 29.9 kg/m2.
. Volunteer is able and willing to comply with the study instructions.
. Volunteer is suitable for participation in the study according to the investigator/study personnel.
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.
What they're measuring
1
Anxiety (STAI-X1, state)
Timeframe: Baseline and after 4 weeks (before and during stress protocol TSST).
2
Anxiety (VAS)
Timeframe: Baseline and after 4 weeks (before and during stress protocol TSST).
. Voluntary, written informed consent to participate in the study.
Exclusion criteria
. No command of local language.
. Previously or currently diagnosed neurological or psychiatric disorders.
. Previous history of renal, hepatic, cardiovascular disease or clinically significant diabetes.
. Gastrointestinal disorders including irritable bowel syndrome (IBS), inflammatory bowel disease (IBD) or other conditions that might affect the gut environment.
. Contraindication or allergy to any substance in the verum or placebo product incl. lactose or fructose intolerance.
. Use of drugs (e.g., antibiotics, aspirin, proton pump inhibitors) influencing gastrointestinal function in the previous 8 weeks before the beginning of intervention.
. Use of laxatives and labelled pre-and probiotics in the previous 4 weeks before the beginning of intervention.
. Participation in another study with any investigational product within 30 days of screening or during the study.