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.
Volunteer is healthy at the time of screening.
TICS Screening Scale of Chronic Stress (SSCS) score ≥ 6.
GAD total score ≥ 5 and ≤ 14 indicating mild to moderate anxiety.
Male or female aged ≥18 and ≤ 70 years at the time of screening.
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.
Parallel
Prebiotic fiber
Dietary supplementChicory root-derived prebiotic fiber
Placebo control
Dietary supplementMaltodextrin
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.
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.
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.
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.
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.
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.
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)
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Beneo-Institute
Lead sponsor
Daacro
Collaborator
