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Beneficial Effects of A Diverse Prebiotic Fibre bLend on Affect, iNflammation, Cognition, and the Gut microbiomE: a Double-blind Placebo Controlled Randomised Controlled Trial
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.
Age
18 - 50 years
Sex
ALL
Healthy Volunteers
No
BALANCE Study Site
London, United Kingdom
Start Date
January 1, 2027
Primary Completion Date
January 1, 2028
Completion Date
March 1, 2028
Last Updated
March 20, 2026
120
ESTIMATED participants
Prebiotic fibre blend
DIETARY_SUPPLEMENT
Maltodextrin (Placebo)
DIETARY_SUPPLEMENT
Lead Sponsor
Myota GmbH
Collaborators
NCT07360600
NCT07478393
Data Source & Attribution
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