An interventional study of Prebiotic fiber and Placebo control in Stress, Healthy Subjects and Anxiety, Mild to Moderate, sponsored by Beneo-Institute. Recruiting at 1 site in Germany. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-07.
Sponsored by Beneo-Institute · Not applicable, Interventional, and Prevention
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.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's planned enrollment of 204 is above the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Beneo-Institute is the lead sponsor of 12 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
The prebiotic fiber group will receive prebiotic fiber during the 4-week intervention period.
Dietary Supplement: Prebiotic fiber
The placebo group will receive maltodextrin during the 4-week intervention period.
Dietary Supplement: Placebo control
Chicory root-derived prebiotic fiber
Maltodextrin
Anxiety (STAI-X1, state)
Anxiety as a temporary emotional state will be assessed with State-Trait-Anxiety Inventory (STAI-X1, state). Total scores range from 20-80, with higher scores indicate greater levels of current anxiety.
Time frame: Baseline and after 4 weeks (before and during stress protocol TSST).
Anxiety (VAS)
Anxiety as a temporary emotional state will be assessed with 100-mm visual analogue scale (VAS). Higher scores shown in VAS indicating higher levels of anxiety.
Time frame: Baseline and after 4 weeks (before and during stress protocol TSST).
Beck's Anxiety Inventory (BAI)
Beck's Anxiety Inventory (BAI) will be assessed using a 21-item self-reported questionnaire. Total scores range from 0 to 63, with lower scores indicating lower levels of anxiety.
Time frame: Four weeks.
Beck's Depression Inventory (BDI)
Beck's Depression Inventory (BDI) will be assessed using a 21-question self-reported rating inventory in a multiple choice format. Total scores range from 0 to 63, with lower scores indicating lower levels of depression.
Time frame: Four weeks.
Depression Anxiety Stress Scale (DASS)
Depression Anxiety Stress Scale (DASS) will be assessed using a 21-item questionnaire that include three scales (depression, anxiety and stress) of which each scale includes 7 items, and responses are rated on a 4-point scale (0-3). Higher scores on each subscale indicate greater symptom severity.
Time frame: Four weeks.
Positive and Negative Affect Schedule (PANAS)
Positive and Negative Affect Schedule (PANAS) will be assessed using 20 self-reported measures of 10 positive and negative affect items, respectively. Total scores range from 10 to 50, with higher scores indicating higher levels of positive and negative affects.
Time frame: Four weeks.
Salivary cortisol
Chronic stress, but also anxiety and depression can permanently increase cortisol levels and impair various physical and mental functions.
Time frame: Baseline and after 4 weeks (before and during stress protocol TSST).
Blood pressure
Blood pressure (BP, systolic and diastolic) will be measured using an automated blood pressure measurement device (OMRON Medizintechnik).
Time frame: Baseline and after 4 weeks (before and during stress protocol TSST).
Gut microbiota
Stool samples will be collected for gut microbiota profile analysis.
Time frame: Four weeks.
Dietary intake
Dietary intake will be recorded during the study using online dietary assessment tool (MyFood24).
Time frame: Four weeks.
Pulse/heart rate
Pulse/heart rate will be measured through Somno HD eco (Somnomedics), using an ECG and continuous BP measurement based on pulse transit time (PTT)
Time frame: Baseline and after 4 weeks (before and during stress protocol TSST).
Adverse events (AEs)
All AEs will be collected in the eCRF. The intensity/severity rating is defined as: 1 = mild (awareness of sign or symptom, but easily tolerated); 2 = moderate (discomfort sufficient to cause interference with normal activities); 3 = severe (incapacitating, with inability to perform normal activities)
Time frame: Through study completion, up to 4 weeks.
Plan to share: No
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