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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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.
• Email: YoghatamaCindya.Zanzer@beneo.com
• Phone: +496359803-9756

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.