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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
120
A blend of prebiotic fibres in a powdered supplement form.
Maltodextrin powder
BALANCE Study Site
London, United Kingdom
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).
Time frame: Baseline and 12 weeks
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).
Time frame: Baseline and 8 weeks
Depression
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Week 8 and Week 12