BALANCE Study
Research type
Research Study
Full title
BALANCE Study: Beneficial effects of A diverse prebiotic fibre bLend on Affect, iNflammation, Cognition, and the gut microbiomE: a double-blind placebo controlled randomised controlled trial
IRAS ID
369104
Contact name
Piril Hepsomali
Contact email
Sponsor organisation
Myota Ltd
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
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.
A key mechanism linking the gut to stress regulation involves the fermentation of dietary fibre into short-chain fatty acids (SCFAs), particularly acetate, propionate and butyrate. Prebiotic fibres, specific fermentable fibres that selectively promote the growth and activity of beneficial gut bacteria, have emerged as a promising nutritional intervention to enhance SCFA production.
As prebiotic fibre research is an emerging area, there is limited evidence on the minimum effective doses from a supplement required to elicit measurable changes in the gut microbiome and downstream stress-related outcomes. In our previous studies (14, 15), we have used doses of 10-20g per day. In this study, we aim to investigate whether a lower dose (6g) can also modulate the gut microbiome and thus, our primary and secondary outcomes of interest. By including a lower dose arm, we can begin to characterise dose–response relationships and optimise both efficacy and acceptability of prebiotic interventions for stress reduction.
In this study, we propose to investigate whether daily supplementation with a SCFA-optimised prebiotic fibre blend can reduce self-reported stress in otherwise healthy adults with elevated stress levels. The study will enrol 120 participants aged 18–50 with mild to severe stress, randomised to receive either a prebiotic fibre blend (either a 6g or 10g dose) or a placebo (10g).
REC name
London - Central Research Ethics Committee
REC reference
26/LO/0255
Date of REC Opinion
15 Apr 2026
REC opinion
Further Information Favourable Opinion