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| Name | Class |
|---|---|
| Daacro | NETWORK |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prebiotic fiber | Experimental | The prebiotic fiber group will receive prebiotic fiber during the 4-week intervention period. |
|
| Placebo control | Placebo Comparator | The placebo group will receive maltodextrin during the 4-week intervention period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prebiotic fiber | Dietary Supplement | Chicory root-derived prebiotic fiber |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline and after 4 weeks (before and during stress protocol TSST). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Four weeks. |
| Beck's Depression Inventory (BDI) |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs) | All AEs will be collected in the eCRF. The intensity/severity rating is defined as: 1 = mild (awareness of sign or symptom, but easily tolerated); 2 = moderate (discomfort sufficient to cause interference with normal activities); 3 = severe (incapacitating, with inability to perform normal activities) | Through study completion, up to 4 weeks. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yoghatama Cindya Zanzer, Ph.D. | Contact | +496359803-9756 | YoghatamaCindya.Zanzer@beneo.com |
| Name | Affiliation | Role |
|---|---|---|
| Juliane Hellhammer, Ph.D. | Daacro GmbH & Co. KG | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| daacro GmbH & Co. KG | Recruiting | Trier | Rhineland-Palatinate | 54296 | Germany |
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To reduce potential bias, the study will blind all key parties involved: participants, investigators, and those evaluating the outcomes.
| Placebo control |
| Dietary Supplement |
Maltodextrin |
|
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. |
| 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. | 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. | Four weeks. |
| Salivary cortisol | Chronic stress, but also anxiety and depression can permanently increase cortisol levels and impair various physical and mental functions. | 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). | Baseline and after 4 weeks (before and during stress protocol TSST). |
| Gut microbiota | Stool samples will be collected for gut microbiota profile analysis. | Four weeks. |
| Dietary intake | Dietary intake will be recorded during the study using online dietary assessment tool (MyFood24). | 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) | Baseline and after 4 weeks (before and during stress protocol TSST). |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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