Stress
Conditions
Keywords
gut-brain axis, perceived stress, prebiotic fibre, cognitive function, anxiety, mood, depression, inflammation
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTPrebiotic fibre blend
A blend of prebiotic fibres in a powdered supplement form.
DIETARY_SUPPLEMENTMaltodextrin (Placebo)
Maltodextrin powder
Sponsors
Myota GmbH
University of Reading
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Study sponsor
Intervention model description
Three-arm, double-blind, placebo-controlled randomised trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Aged 18-50 years of age * Capacity to give informed consent to participate in the study * Able to comply with study requirements and visits * Meet the criteria for mild-severe stress levels (scores between 15-33) as assessed by DASS-42 Stress Subscale * Normal or corrected to normal vision and/or hearing
Exclusion criteria
* Current smoker * Having food allergies and/or intolerances * Current diagnosis of Type 1 or 2 diabetes, cardiovascular disease, or psychiatric or neurological conditions (e.g. schizophrenia, dementia) including eating disorders * Current or previous diagnosis of depression in past 6 months * Currently receiving medications that lower cholesterol, blood pressure, blood glucose levels, or improve insulin sensitivity * Receiving antidepressant or anti-anxiety medications or treatments * Receiving hormonal birth control * Perimenopause or menopause * Pregnancy, lactation, or an intent to become pregnant during the course of the study * Continuous antibiotic use for \> 3 days within 1 month prior to enrolment * Continuous use of weight-loss drug for \> 1 month before screening * Major change in dietary intake in past month (e.g. excluding whole food groups) * Consuming a restricted diet, including a vegan, vegetarian, and ketogenic diet * Currently consuming daily prebiotic or probiotic supplements * Any significant GI condition affecting absorption including (but not limited to) inflammatory bowel disease, weight loss surgery, irritable bowel syndrome. * Active cancer, or treatment for any cancer, in last 3 years * Consuming more than 20g of fibre a day as assessed by the FiberScreen
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Stress | Baseline and 12 weeks | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Stress | Baseline and 8 weeks | 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). |
| Depression | Baseline, 8 weeks and 12 weeks | 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). |
| Mood | Baseline, 8 weeks and 12 weeks | 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). |
| Anxiety | Baseline, Week 8, and Week 12 | 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). |
| Serum hs-CRP | Baseline and Week 12 | 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). |
| Cognition: Auditory Verbal Learning Task (AVLT) | Baseline and Week 12 | 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. |
| Cognition: Affective 2-Back Task | Baseline and Week 12 | 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. |
| Cognition: Emotional Go/No-Go | Baseline and Week 12 | 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. |
| Cognition: Attentional Network Task (ANT) | Baseline and Week 12 | 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. |
| Cognition: Number Letter Task | Baseline and Week 12 | 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. |
| Gastrointestinal symptoms | Baseline, Week 8 and Week 12 | 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. |
Countries
United Kingdom
Contacts
CONTACTThomas Gurry, PhD
Outcome results
None listed