StressPRIMENCT07058324
The Effects of Chicory Root-derived Prebiotic on Mood and Stress Responsiveness in Healthy Adults With Mild to Moderate Levels of Stress and Anxiety
A study testing Prebiotic fiber in people with Stress and Healthy Subjects, run by Beneo-Institute at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Healthy Subjects, Anxiety, Mild to Moderate
- What is being tested?
- Prebiotic fiber
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 204 participants
- Where
- 1 siteGermany
- Study dates
- 2 Jun 2025to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
daacro GmbH & Co. KG
Trier, Rhineland-Palatinate, 54296
Franziska Schmitt, M.Sc., +496519120-494, schmitt@daacro.de
Juliane Hellhammer, Ph.D.
About this study
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: a Randomized, Placebo-controlled, Double-blind, Monocentric, Two-armed Parallel, Prospective Study - The PRIME Study
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
- Stress, Healthy Subjects, Anxiety, Mild to Moderate
- Being tested
- Prebiotic fiber, Placebo control
- Keywords
- anxiety, prebiotics
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prebiotic fiberDietary supplement
Chicory root-derived prebiotic fiber
Placebo controlDietary supplement
Maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| Prebiotic fiber | Experimental | The prebiotic fiber group will receive prebiotic fiber during the 4-week intervention period. Receives: Dietary Supplement: Prebiotic fiber |
| Placebo control | Placebo comparator | The placebo group will receive maltodextrin during the 4-week intervention period. Receives: Dietary Supplement: Placebo control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety (STAI-X1, state)
Anxiety as a temporary emotional state will be assessed with State-Trait-Anxiety Inventory (STAI-X1, state). Total scores range from 20-80, with higher scores indicate greater levels of current anxiety.
Measured: Baseline and after 4 weeks (before and during stress protocol TSST).
Anxiety (VAS)
Anxiety as a temporary emotional state will be assessed with 100-mm visual analogue scale (VAS). Higher scores shown in VAS indicating higher levels of anxiety.
Measured: Baseline and after 4 weeks (before and during stress protocol TSST).
Secondary outcomes (9)
Beck's Anxiety Inventory (BAI)
Beck's Anxiety Inventory (BAI) will be assessed using a 21-item self-reported questionnaire. Total scores range from 0 to 63, with lower scores indicating lower levels of anxiety.
Measured: Four weeks.
Beck's Depression Inventory (BDI)
Beck's Depression Inventory (BDI) will be assessed using a 21-question self-reported rating inventory in a multiple choice format. Total scores range from 0 to 63, with lower scores indicating lower levels of depression.
Measured: Four weeks.
Depression Anxiety Stress Scale (DASS)
Depression Anxiety Stress Scale (DASS) will be assessed using a 21-item questionnaire that include three scales (depression, anxiety and stress) of which each scale includes 7 items, and responses are rated on a 4-point scale (0-3). Higher scores on each subscale indicate greater symptom severity.
Measured: Four weeks.
Positive and Negative Affect Schedule (PANAS)
Positive and Negative Affect Schedule (PANAS) will be assessed using 20 self-reported measures of 10 positive and negative affect items, respectively. Total scores range from 10 to 50, with higher scores indicating higher levels of positive and negative affects.
Measured: Four weeks.
Salivary cortisol
Chronic stress, but also anxiety and depression can permanently increase cortisol levels and impair various physical and mental functions.
Measured: Baseline and after 4 weeks (before and during stress protocol TSST).
Blood pressure
Blood pressure (BP, systolic and diastolic) will be measured using an automated blood pressure measurement device (OMRON Medizintechnik).
Measured: Baseline and after 4 weeks (before and during stress protocol TSST).
Gut microbiota
Stool samples will be collected for gut microbiota profile analysis.
Measured: Four weeks.
Dietary intake
Dietary intake will be recorded during the study using online dietary assessment tool (MyFood24).
Measured: Four weeks.
Pulse/heart rate
Pulse/heart rate will be measured through Somno HD eco (Somnomedics), using an ECG and continuous BP measurement based on pulse transit time (PTT)
Measured: Baseline and after 4 weeks (before and during stress protocol TSST).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start2 Jun 2025
- Primary completionJun 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beneo-Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Daacro
- Responsible party
- Sponsor
- Investigators
- Juliane Hellhammer, Ph.D., Principal investigator, Daacro GmbH & Co. KG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07058324
- Sponsor's protocol ID
- Be01-2025
- Acronym
- PRIME
- Status last verified
- Aug 2025
- First submitted
- 2 Jun 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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: a Randomized, Placebo-controlled, Double-blind, Monocentric, Two-armed Parallel, Prospective Study - The PRIME Study
- ClinicalTrials.gov ID
- NCT07058324
- Acronym / sponsor ID
- PRIME / Be01-2025
- Conditions
- Stress, Healthy Subjects, Anxiety, Mild to Moderate
- Keywords
- anxiety, prebiotics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Beneo-InstituteIndustry (pharma, biotech, devices)
- Collaborators
- Daacro
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 10 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prebiotic fiber | Experimental | Dietary Supplement: Prebiotic fiberThe prebiotic fiber group will receive prebiotic fiber during the 4-week intervention period. |
| Placebo control | Placebo comparator | Dietary Supplement: Placebo controlThe placebo group will receive maltodextrin during the 4-week intervention period. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prebiotic fiberChicory root-derived prebiotic fiber | Dietary supplement | Prebiotic fiber |
| Placebo controlMaltodextrin | Dietary supplement | Placebo control |
Primary outcome
Anxiety (STAI-X1, state)
Time frame: Baseline and after 4 weeks (before and during stress protocol TSST).
Anxiety as a temporary emotional state will be assessed with State-Trait-Anxiety Inventory (STAI-X1, state). Total scores range from 20-80, with higher scores indicate greater levels of current anxiety.
Anxiety (VAS)
Time frame: Baseline and after 4 weeks (before and during stress protocol TSST).
Anxiety as a temporary emotional state will be assessed with 100-mm visual analogue scale (VAS). Higher scores shown in VAS indicating higher levels of anxiety.
9 secondary outcomes
Beck's Anxiety Inventory (BAI)
Time frame: Four weeks.
Beck's Depression Inventory (BDI)
Time frame: Four weeks.
Depression Anxiety Stress Scale (DASS)
Time frame: Four weeks.
Positive and Negative Affect Schedule (PANAS)
Time frame: Four weeks.
Salivary cortisol
Time frame: Baseline and after 4 weeks (before and during stress protocol TSST).
Blood pressure
Time frame: Baseline and after 4 weeks (before and during stress protocol TSST).
Gut microbiota
Time frame: Four weeks.
Dietary intake
Time frame: Four weeks.
Pulse/heart rate
Time frame: Baseline and after 4 weeks (before and during stress protocol TSST).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Juliane Hellhammer, Ph.D. principal investigator
Daacro GmbH & Co. KG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prebiotic fiber in people with Stress and Healthy Subjects, run by Beneo-Institute at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yoghatama Cindya Zanzer, Ph.D. (+496359803-9756, YoghatamaCindya.Zanzer@beneo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (STAI-X1, state) (time frame: Baseline and after 4 weeks (before and during stress protocol TSST).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.