The Effects of Chicory Root-derived Prebiotic on Mood and Stress Responsiveness in Healthy Adults With Mild to Moderate Levels of Stress and Anxiety

Not Applicable

Recruiting

• Conditions: Stress; Healthy Subjects; Anxiety, Mild to Moderate

• Registration Number: NCT07058324
• Lead Sponsor: Beneo-Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-06-02
• Study First Submitted: 2025-06-02
• Study First Submitted QC: 2025-06-30
• Study First Posted: 2025-07-10
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-04
• Last Update Posted: 2025-08-07
• Primary Completion: 2026-06
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 204

Inclusion Criteria

1. Volunteer is healthy at the time of screening.
2. TICS Screening Scale of Chronic Stress (SSCS) score ≥ 6.
3. GAD total score ≥ 5 and ≤ 14 indicating mild to moderate anxiety.
4. Male or female aged ≥18 and ≤ 70 years at the time of screening.
5. Body-Mass-Index (BMI) ≥ 18.5 and ≤ 29.9 kg/m2.
6. Volunteer is able and willing to comply with the study instructions.
7. Volunteer is suitable for participation in the study according to the investigator/study personnel.
8. Voluntary, written informed consent to participate in the study.

Exclusion Criteria

1. No command of local language.
2. Previously or currently diagnosed neurological or psychiatric disorders.
3. Previous history of renal, hepatic, cardiovascular disease or clinically significant diabetes.
4. Gastrointestinal disorders including irritable bowel syndrome (IBS), inflammatory bowel disease (IBD) or other conditions that might affect the gut environment.
5. Contraindication or allergy to any substance in the verum or placebo product incl. lactose or fructose intolerance.
6. Use of drugs (e.g., antibiotics, aspirin, proton pump inhibitors) influencing gastrointestinal function in the previous 8 weeks before the beginning of intervention.
7. Use of laxatives and labelled pre-and probiotics in the previous 4 weeks before the beginning of intervention.
8. Participation in another study with any investigational product within 30 days of screening or during the study.
9. History of drug (recreational) or alcohol abuse.
10. Use of anti-depressants medication including selective serotonin receptor inhibitors or amitriptyline for 3 months prior to screening.
11. Bowel preparation for investigative procedures in the 4 weeks prior to screening.
12. Surgical resection of any part of the bowel.
13. Pregnant or lactating.
14. Regular smoking.
15. Previous Trier Social Stress Test (TSST) participation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Anxiety (STAI-X1, state)	Baseline and after 4 weeks (before and during stress protocol TSST).	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)	Baseline and after 4 weeks (before and during stress protocol TSST).	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.

Secondary Outcome Measures

Name	Time	Method
Beck's Anxiety Inventory (BAI)	Four weeks.	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)	Four weeks.	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)	Four weeks.	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)	Four weeks.	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.
Salivary cortisol	Baseline and after 4 weeks (before and during stress protocol TSST).	Chronic stress, but also anxiety and depression can permanently increase cortisol levels and impair various physical and mental functions.
Blood pressure	Baseline and after 4 weeks (before and during stress protocol TSST).	Blood pressure (BP, systolic and diastolic) will be measured using an automated blood pressure measurement device (OMRON Medizintechnik).
Gut microbiota	Four weeks.	Stool samples will be collected for gut microbiota profile analysis.
Dietary intake	Four weeks.	Dietary intake will be recorded during the study using online dietary assessment tool (MyFood24).
Pulse/heart rate	Baseline and after 4 weeks (before and during stress protocol TSST).	Pulse/heart rate will be measured through Somno HD eco (Somnomedics), using an ECG and continuous BP measurement based on pulse transit time (PTT)

Trial Locations

Locations (1)

daacro GmbH & Co. KG; 🇩🇪 Trier, Rheinland-Pfalz, Germany