NCT07201909

CALM Study: Can A Prebiotic Fibre bLend Improve Stress, Mood, and Anxiety?

Can A Prebiotic Fibre bLend Improve Stress, Mood, and Anxiety? Assessing the Impact of a Daily Prebiotic Fibre Blend on Affect, Inflammation, and the Gut Microbiome: a 12-week Double-blind Placebo-controlled RCT

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 156 (estimated)
• Sponsor: Myota GmbH · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial will investigate whether a powdered prebiotic fibre blend 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. 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.

Conditions

• Stress

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Prebiotic fibre blend	A blend of prebiotic fibres in a powdered supplement form.
DIETARY_SUPPLEMENT	Maltodextrin powder	Maltodextrin powder

Timeline

• Start date: 2025-10-02
• Primary completion: 2026-09-30
• Completion: 2026-12-30
• First posted: 2025-10-01
• Last updated: 2026-03-13

Locations

1 site across 1 country: United Kingdom