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Search / Trial 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

Launched by BENEO-INSTITUTE · Jun 30, 2025

Trial Information

Current as of July 13, 2025

Not yet recruiting

Keywords

Anxiety Prebiotics

ClinConnect Summary

This clinical trial is looking at whether a special type of fiber made from chicory root can help improve mood and reduce stress in healthy adults who experience mild to moderate levels of stress and anxiety. Researchers are interested in this fiber because it may support mental health by improving the connection between the gut and the brain, an area scientists are learning more about. Chicory root fiber is already known to help with blood sugar control and digestion, and this study will explore its potential benefits for mental well-being in a larger group of people.

To join the study, participants should be adults between 18 and 70 years old who are generally healthy but experiencing some mild to moderate stress and anxiety. People with certain health conditions, like serious gut problems, recent antibiotic use, or current psychiatric disorders, will not be eligible. Participants will be asked to follow study instructions closely and give their written consent before joining. While the study is not yet recruiting, those interested can expect to be part of research that aims to find new, natural ways to support mental health through diet.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Volunteer is healthy at the time of screening.
  • 2. TICS Screening Scale of Chronic Stress (SSCS) score ≥ 6 (Schulz et al., 2004).
  • 3. GAD total score ≥ 5 and ≤ 14 indicating mild to moderate anxiety (Spitzer et al., 2006).
  • 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.

About Beneo Institute

Beneo-Institute is a leading research organization dedicated to advancing the understanding of nutrition and health through innovative clinical trials. Focused on the development and evaluation of functional ingredients derived from natural sources, Beneo-Institute collaborates with academic institutions and industry partners to explore their effects on metabolic health, digestive well-being, and overall wellness. With a commitment to scientific rigor and evidence-based practices, the institute aims to contribute valuable insights that support the formulation of effective dietary solutions and enhance public health outcomes.

Locations

Trier, Rheinland Pfalz, Germany

Patients applied

0 patients applied

Trial Officials

Juliane Hellhammer, Ph.D.

Principal Investigator

Daacro GmbH & Co. KG

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported