Chicory root prebiotic for mood and stress in adults with mild to moderate anxiety

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

This study will test whether a chicory root–derived prebiotic can help reduce stress and mild to moderate anxiety in healthy adults.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 204 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Beneo-Institute (Industry-sponsored)
• Locations: 1 site (Trier, Rhineland-Palatinate)
• Trial ID: NCT07058324 on ClinicalTrials.gov

What this trial studies

Healthy adults with mild to moderate anxiety will be enrolled and must meet screening thresholds for chronic stress and GAD scores; people with major medical, psychiatric, or gastrointestinal disorders are excluded. Participants will receive either a chicory root–derived prebiotic fiber or a matching placebo and will follow study instructions for the intervention period. Mood and stress responsiveness will be measured with standardized questionnaires and behavioral/physiological assessments over the course of the treatment. The trial is sponsored by the Beneo-Institute and run at a CRO site in Trier, Germany.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18–70 with mild to moderate anxiety (GAD score 5–14), elevated chronic stress screening scores, BMI 18.5–29.9, and no major medical, psychiatric, or gastrointestinal conditions.

Not a fit: People with diagnosed neurological or psychiatric disorders, significant medical illnesses (renal, hepatic, cardiovascular, diabetes), gastrointestinal diseases like IBS/IBD, severe anxiety, or those outside the age/BMI ranges may not benefit from this trial.

Why it matters

Potential benefit: If successful, this could provide a safe, diet-based option to help reduce stress and mild-to-moderate anxiety symptoms.

How similar studies have performed: Preclinical work and a few small human studies of prebiotic fibers have suggested possible mood and stress benefits, but results so far are preliminary and not definitive.

Eligibility criteria

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.

Where this trial is running

Trier, Rhineland-Palatinate

• daacro GmbH & Co. KG — Trier, Rhineland-Palatinate, Germany (Recruiting)

Study contacts

• Principal investigator: Juliane Hellhammer, Ph.D. — Daacro GmbH & Co. KG
• Study coordinator: Yoghatama Cindya Zanzer, Ph.D.

Conditions Stress; Healthy Subjects; Anxiety, Mild to Moderate; anxiety; prebiotics