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| Name | Class |
|---|---|
| University of Reading | OTHER |
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This clinical trial will investigate whether a powdered prebiotic fibre blend, at two doses, can improve perceived stress levels in healthy adults with mild-severe stress levels.
There is growing interest in how the gut microbiota interacts with the brain to influence psychological outcomes, particularly stress. Even in otherwise healthy individuals, persistent psychological stress is associated with measurable physiological changes-including elevated cortisol levels, heightened hypothalamic-pituitary-adrenal (HPA) axis reactivity, and systemic low-grade inflammation. These biological signatures are increasingly understood to be shaped, in part, by the composition and activity of the gut microbiota.
This study will investigate how a powdered prebiotic fibre supplement can affect stress levels. Secondary endpoints include the effects that the prebiotic fibre supplement will have on other areas of health, like depression, mood, anxiety, cognition, inflammation, and the gut microbiome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prebiotic fibre blend (6g) | Experimental | Prebiotic fibre blend, consisting of 6g of a powdered supplement, to be taken daily alongside usual |
|
| Prebiotic fibre blend (10g) | Experimental | Prebiotic fibre blend, consisting of 10g of a powdered supplement, to be taken daily alongside usual diet for 12 weeks. |
|
| Placebo | Placebo Comparator | Placebo will be 10g of maltodextrin powder, to be taken daily alongside usual diet for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prebiotic fibre blend | Dietary Supplement | A blend of prebiotic fibres in a powdered supplement form. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Perceived Stress | The primary objective is to determine the effect of 12-week long daily administration of Prebiotic fibre blend as compared to Placebo on stress scores (Perceived Stress Scale) on a scale between 0 - 40 (where higher scores indicate higher stress). | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived Stress | To determine the effect of 12-week long daily administration of Prebiotic fibre blend as compared to Placebo on stress scores (Perceived Stress Scale) on a scale between 0 - 40 (where higher scores indicate higher stress). | Baseline and 8 weeks |
| Depression |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory: Sleep quality | To determine the effect of 12-week daily administration of Prebiotic fibre blend as compared to Placebo on sleep quality (PSQI), on a scale of 0 - 21 where higher scores indicate worse sleep. | Baseline and Week 12 |
| Exploratory: Quality of Life Index |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thomas Gurry, PhD | Contact | 797908227 | +41 | thomas@myotahealth.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BALANCE Study Site | Recruiting | London | EC2A 4BQ | United Kingdom |
Participant data will not be shared.
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| C008315 | maltodextrin |
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Three-arm, double-blind, placebo-controlled randomised trial
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Study sponsor
| Maltodextrin (Placebo) | Dietary Supplement | Maltodextrin powder |
|
To determine the effect of 12-week daily administration of Prebiotic fibre blend as compared to Placebo on depression scores (PHQ-8), on a scale between 0 - 24 (where higher scores mean higher depression). |
| Baseline, 8 weeks and 12 weeks |
| Mood | To determine the effect of 12-week daily administration of Prebiotic fibre blend as compared to Placebo on mood scores (PANAS-X), on a scale between 10 - 50 (where higher scores on the Positive Affect scale indicate higher levels of positive engagement with your environment; while higher scores on the Negative Affect scale indicate higher levels of negative engagement). | Baseline, 8 weeks and 12 weeks |
| Anxiety | To determine the effect of 12-week daily administration of Prebiotic fibre blend as compared to Placebo on anxiety scores (GAD-7), on a scale between 0 - 21 (where higher scores mean higher anxiety levels). | Baseline, Week 8, and Week 12 |
| Serum hs-CRP | To determine the effect of 12-week daily administration of Prebiotic fibre blend as compared to Placebo on serum high sensitivity C-Reactive Protein (hs-CRP). | Baseline and Week 12 |
| Cognition: Auditory Verbal Learning Task (AVLT) | To determine the effect of 12-week daily administration of Prebiotic fibre blend as compared to Placebo on immediate and delayed word recognition, as assessed by the AVLT where better scores are achieved by higher number or recalled words and lower error rate. | Baseline and Week 12 |
| Cognition: Affective 2-Back Task | To determine the effect of 12-week daily administration of Prebiotic fibre blend as compared to Placebo on emotional interference in working memory under emotional load, as assessed by the Affective 2-Back Task, where better scores are achieved by lower reaction times and higher accuracy score. | Baseline and Week 12 |
| Cognition: Emotional Go/No-Go | To determine the effect of 12-week daily administration of Prebiotic fibre blend as compared to Placebo on emotion-related inhibitory control and response suppression, as assessed by the Emotional Go-No-Go, where better scores are achieved by higher correct response rates and lower commission errors. | Baseline and Week 12 |
| Cognition: Attentional Network Task (ANT) | To determine the effect of 12-week daily administration of Prebiotic fibre blend as compared to Placebo on efficiency of alerting, orienting, and executive attention networks, as assessed by the Attentional Network Task, where better scores are achieved by lower reaction times and higher accuracy. | Baseline and Week 12 |
| Cognition: Number Letter Task | To determine the effect of 12-week daily administration of Prebiotic fibre blend as compared to Placebo on cognitive flexibility and task-switching ability, as assessed by the Number Letter Task where better scores are achieved by a higher accuracy of recalled sequences. | Baseline and Week 12 |
| Gastrointestinal symptoms | To determine the effect of 12-week daily administration of Prebiotic fibre blend as compared to Placebo on gastrointestinal symptoms (GSRS), on a scale of 15 - 105 where higher scores indicate more severe gastrointestinal discomfort. | Baseline, Week 8 and Week 12 |
To determine the effect of 12-week daily administration of Prebiotic fibre blend as compared to Placebo on quality of life index (WHOQOL), on a scale of 0 -100 where higher scores indicate higher quality of life. |
| Baseline And Week 12 |
| Exploratory: Serum LDL Cholesterol | To determine the effect of 12-week daily administration of Prebiotic fibre blend as compared to Placebo on serum LDL cholesterol. | Baseline and Week 12 |
| Exploratory: Serum HDL Cholesterol | To determine the effect of 12-week daily administration of Prebiotic fibre blend as compared to Placebo on serum HDL cholesterol. | Baseline and Week 12 |
| Exploratory: Serum Triglycerides | To determine the effect of 12-week daily administration of Prebiotic fibre blend as compared to Placebo on serum triglycerides. | Baseline and Week 12 |
| Exploratory: Total cholesterol | To determine the effect of 12-week daily administration of Prebiotic fibre blend as compared to Placebo on serum total cholesterol. | Baseline and Week 12 |
| Exploratory: Waist to hip ratio | To determine the effect of 12-week daily administration of Prebiotic fibre blend as compared to Placebo on waist to hip ratio. | Baseline and Week 12 |
| Exploratory: Waist circumference | To determine the effect of 12-week daily administration of Prebiotic fibre blend as compared to Placebo on waist circumference (cm). | Baseline and Week 12 |
| Exploratory: Gut microbiome composition | To determine the effect of 12-week daily administration of Prebiotic fibre blend as compared to Placebo on gut microbiome diversity scores (alpha and beta measures) and composition (differential abundance testing). | Baseline and Week 12 |
| Exploratory: Systolic blood pressure | To determine the effect of 12-week daily administration of Prebiotic fibre blend as compared to Placebo on systolic blood pressure (mmHg). | Baseline and Week 12 |
| Exploratory: Diastolic blood pressure | To determine the effect of 12-week daily administration of Prebiotic fibre blend as compared to Placebo on diastolic blood pressure (mmHg). | Baseline and Week 12 |
| Exploratory: BMI | To determine the effect of 12-week daily administration of Prebiotic fibre blend as compared to Placebo on body mass index (BMI) (kg/m2). | Baseline and Week 12 |
| Exploratory: Perceived Stress (follow-up) | To determine the follow-up (week 16) effects of Prebiotic fibre blend, as compared to Placebo, on stress scores (PSS) on a scale between 0 - 40 (where higher scores indicate higher stress). | Week 12 and Week 16 |
| Exploratory: Depression (follow-up) | To determine the follow-up (week 16) effects of Prebiotic fibre blend, as compared to Placebo, on depression scores (PHQ-8) on a scale between 0 - 24 (where higher scores indicate higher stress). | Week 12, and Week 16 |
| Exploratory: Mood (follow-up) | To determine the follow-up (week 16) effects of Prebiotic fibre blend, as compared to Placebo, on mood scores (PANAS-X) on a scale between 10 - 50 (where higher scores on the Positive Affect scale indicate higher levels of positive engagement with your environment; while higher scores on the Negative Affect scale indicate higher levels of negative engagement). | Week 12 and Week 16 |
| Exploratory: Anxiety (follow-up) | To determine the follow-up (week 16) effects of Prebiotic fibre blend, as compared to Placebo, on anxiety scores (GAD-7) on a scale between 0 - 21 (where higher scores mean higher anxiety levels). | Week 12 and Week 16 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |