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

NCT07058324 | Recruiting

• 1 other identifier: Be01-2025
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress; Healthy Subjects; Anxiety, Mild to Moderate

Keywords

anxiety; prebiotics

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline and after 4 weeks (before and during stress protocol TSST).

Secondary Outcomes (9)

• Beck's Anxiety Inventory (BAI)

  Four weeks.

• Beck's Depression Inventory (BDI)

  Four weeks.

• Depression Anxiety Stress Scale (DASS)

  Four weeks.

• Positive and Negative Affect Schedule (PANAS)

  Four weeks.

• Salivary cortisol

  Baseline and after 4 weeks (before and during stress protocol TSST).

Other Outcomes (1)

• Adverse events (AEs)

  Through study completion, up to 4 weeks.

Study Arms (2)

Prebiotic fiber

EXPERIMENTAL

The prebiotic fiber group will receive prebiotic fiber during the 4-week intervention period.

Dietary Supplement: Prebiotic fiber

Placebo control

PLACEBO COMPARATOR

The placebo group will receive maltodextrin during the 4-week intervention period.

Dietary Supplement: Placebo control

Interventions

Prebiotic fiber DIETARY_SUPPLEMENT

Chicory root-derived prebiotic fiber

Prebiotic fiber

Placebo control DIETARY_SUPPLEMENT

Maltodextrin

Placebo control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• Voluntary, written informed consent to participate in the study.

You may not qualify if:

• 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.
• History of drug (recreational) or alcohol abuse.
• Use of anti-depressants medication including selective serotonin receptor inhibitors or amitriptyline for 3 months prior to screening.
• Bowel preparation for investigative procedures in the 4 weeks prior to screening.
• Surgical resection of any part of the bowel.
• Pregnant or lactating.
• Regular smoking.
• Previous Trier Social Stress Test (TSST) participation.

Sponsors & Collaborators

• Beneo-Institute: lead
• Daacro: collaborator

Study Sites (1)

daacro GmbH & Co. KG

Trier, Rhineland-Palatinate, 54296, Germany

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Juliane Hellhammer, Ph.D.

  Daacro GmbH & Co. KG

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yoghatama Cindya Zanzer, Ph.D.

CONTACT

+496359803-9756; YoghatamaCindya.Zanzer@beneo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: To reduce potential bias, the study will blind all key parties involved: participants, investigators, and those evaluating the outcomes.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: July 10, 2025
• Study Start: June 2, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)