NCT04951687

Acute and Chronic Effects of Ecologic Barrier© on Mood and Cognition

The Acute and Chronic Effects of Ecologic Barrier© on Mood and Cognition

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Reading · Academic / Other
• Sex: All
• Age: 65 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This study aims to investigate the acute and chronic effects of an 8 week probiotic intervention (Ecologic Barrier©) on mood and cognitive outcomes in healthy adults.

Detailed description

This study will employ a double-blind, randomised, placebo-controlled crossover design to investigate the acute and chronic effects of an 8 week probiotic intervention (Ecologic Barrier©) on mood and cognitive outcomes in healthy older adults. A total of 30 participants will be enrolled and counterbalanced to receive the active probiotic treatment (2g per day Ecologic Barrier©) or a matched placebo in the first arm, before having a 4 week washout period and continuing with 8 weeks of the second treatment not consumed within the first arm. Outcome measures will be assessed at baseline, 24 hours and 8 weeks within each arm. These will include cognitive measures of affective processing, immediate and delayed verbal memory, visuospatial working memory and executive functions, and mood measures of depressive symptoms, cognitive reactivity, anxiety, stress and general mood. In addition, faecal samples will be collected at all timepoints in order to explore faecal microbiota profiles before and after probiotic treatment.

Conditions

• Cognitive Change
• Mood

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Ecologic Barrier©	5x10\^9 CFU/ 2g per day of Ecologic Barrier©
DIETARY_SUPPLEMENT	Placebo powder	matched placebo

Timeline

• Start date: 2021-08-05
• Primary completion: 2022-07-01
• Completion: 2022-07-01
• First posted: 2021-07-07
• Last updated: 2023-05-23

Locations

1 site across 1 country: United Kingdom