Actively Recruiting
The Effects of Chicory Root-derived Prebiotic on Mood and Stress Responsiveness in Healthy Adults With Mild to Moderate Levels of Stress and Anxiety
Led by Beneo-Institute · Updated on 2025-08-07
204
Participants Needed
1
Research Sites
60 weeks
Total Duration
On this page
Sponsors
B
Beneo-Institute
Lead Sponsor
D
Daacro
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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 including 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
daacro GmbH & Co. KG
Trier, Rhineland-Palatinate, Germany, 54296
Actively Recruiting
Research Team
Y
Yoghatama Cindya Zanzer, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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