NCT06911957

PRECOG Pilot Project

The Impact of Chronic Consumption of Plant-based Fibres on Cognitive Performance, Gut Microbiome and Mental Health Outcomes in Older Adults: a Pilot Randomised Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University of Reading · Academic / Other
• Sex: All
• Age: 60 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This pilot study aims to investigate the chronic effects of a prebiotic blend on cognitive, affective and gut microbiome outcomes in healthy adults aged 60-75 years.

Detailed description

This pilot study will employ a double-blind, randomised, placebo-controlled parallel design to investigate the chronic effects of 12-week-long prebiotic blend consumption on cognitive, affective, gut microbiome, metabolic, and anthropometric outcomes in healthy older adults with mild to moderate subjective cognitive complaints. Fifty participants will be randomised to Intervention or Placebo groups where they will be consuming 10g of prebiotic fibre blend or 10g of placebo (matched placebo powder) per day for 12-weeks. Outcome measures will be acquired before and after a 12-week chronic supplementation. These will include cognitive measures of overall cognitive functioning, and domain-specific cognitive performance, affective measures of depression and anxiety symptomatology; gastrointestinal symptomatology; systolic and diastolic blood pressure, as well as height, weight, hip and waist circumference. In addition, stool samples will be collected at all timepoints to assess microbiome diversity and composition.

Conditions

• Cognition
• Affect (Mental Function)
• Gut Microbiome

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Prebiotic blend	10g of prebiotic fibre blend powder
DIETARY_SUPPLEMENT	Placebo	10g of matched placebo powder

Timeline

• Start date: 2025-05-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2025-04-04
• Last updated: 2025-12-03

Locations

1 site across 1 country: United Kingdom