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Recruiting NCT07058324

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

No phase Interventional Stress Healthy Subjects Anxiety, Mild to Moderate

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Prebiotic fiber, Placebo control.
Who it may be relevant to
Registry conditions: Stress, Healthy Subjects, Anxiety, Mild to Moderate. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

The Effects of Chicory Root-derived Prebiotic on Mood and Stress Responsiveness in Healthy Adults With Mild to Moderate Levels of Stress and Anxiety: a Randomized, Placebo-controlled, Double-blind, Monocentric, Two-armed Parallel, Prospective Study - The PRIME Study

Overview

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.

Interventions

  • Dietary supplement Prebiotic fiber
    Chicory root-derived prebiotic fiber
  • Dietary supplement Placebo control
    Maltodextrin

Primary outcome measures

  • Anxiety (STAI-X1, state) [Time frame: Baseline and after 4 weeks (before and during stress protocol TSST).]
  • Anxiety (VAS) [Time frame: Baseline and after 4 weeks (before and during stress protocol TSST).]
Secondary outcome measures (9)
  • Beck's Anxiety Inventory (BAI) [Time frame: Four weeks.]
  • Beck's Depression Inventory (BDI) [Time frame: Four weeks.]
  • Depression Anxiety Stress Scale (DASS) [Time frame: Four weeks.]
  • Positive and Negative Affect Schedule (PANAS) [Time frame: Four weeks.]
  • Salivary cortisol [Time frame: Baseline and after 4 weeks (before and during stress protocol TSST).]
  • Blood pressure [Time frame: Baseline and after 4 weeks (before and during stress protocol TSST).]
  • Gut microbiota [Time frame: Four weeks.]
  • Dietary intake [Time frame: Four weeks.]
  • Pulse/heart rate [Time frame: Baseline and after 4 weeks (before and during stress protocol TSST).]

Eligibility criteria

Inclusion criteria

  • 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.

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.
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Prevention

Study locations

Germany · 1 center
  • daacro GmbH & Co. KG — Trier

Identifiers

NCT: NCT07058324 · Be01-2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗