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

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.