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

Beneo

Status: Not yet enrolling

Conditions: Healthy Subjects; Anxiety, Mild to Moderate; Stress

Treatments: Dietary Supplement: Placebo control; Dietary Supplement: Prebiotic fiber

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT07058324

Be01-2025

Details and patient eligibility

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.

Enrollment: 204 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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204 participants in 2 patient groups, including a placebo group

Prebiotic fiber

Experimental group

Description:

The prebiotic fiber group will receive prebiotic fiber during the 4-week intervention period.

Treatment:

Dietary Supplement: Prebiotic fiber

Placebo control

Placebo Comparator group

Description:

The placebo group will receive maltodextrin during the 4-week intervention period.

Treatment:

Dietary Supplement: Placebo control