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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 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.
In this study, we're investigating how a powdered prebiotic fibre supplement can improve stress levels. You may have heard people refer to this as the 'gut-brain axis'. We'll also be looking at the link between the prebiotic fibre supplement intake and changes in 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 | 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 |
|---|---|---|
| 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 |
| Quality of Life Index |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caitlin Hall, PhD, RD | Contact | 07830709854 | caitlin@myotahealth.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CALM 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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Two-arm, double-blind, placebo-controlled randomised trial
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Study Sponsor
| Maltodextrin powder | Dietary Supplement | Maltodextrin powder |
|
To determine the effect of 12-week daily administration of Prebiotic fibre blend as compared to Placebo on depression scores (DASS-42), on a scale between 0 - 21 (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 (DASS-42), 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 |
| 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 |
| Cognition: Emotional Stroop | To determine the effect of 12-week daily administration of Prebiotic fibre blend as compared to Placebo on emotional interference in attention and processing (reaction time and accuracy), as assessed by the Emotional Stroop where better scores are achieved by lower reaction times and higher accuracy score. | 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: 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 higher numbers of correctly recalled items. | Baseline and Week 12 |
| Cognition: Attentional Network Task | 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 |
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| BMI | To determine the effect of 12-week daily administration of Prebiotic fibre blend as compared to Placebo on BMI (kg/m2). | Baseline and Week 12 |
| Exploratory endpoint | Inter-dependencies between primary and secondary outcomes will be assessed. | Baseline, Week 8, and Week 12 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |