NCT06796712

BiomeBakery Project

BiomeBakery: A Randomised Controlled Parallel Trial to Investigate the Cognitive, Affective, Inflammatory and Metabolic Effects of Chronic Prebiotic-fortified Functional Bakery Product Intervention in Older Adults

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: University of Reading · Academic / Other
• Sex: All
• Age: 60 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This study aims to investigate the chronic effects of prebiotic fibre-fortified functional bakery product on cognitive, affective, inflammatory, metabolic, and anthropometric outcomes in healthy adults aged 60-75 years with mild to moderate subjective cognitive complaints.

Detailed description

This study will employ a double-blind, randomised, placebo-controlled parallel design to investigate the chronic effects of an 12 week prebiotic fibre-fortified functional bakery product on cognitive, affective, inflammatory, metabolic, and anthropometric outcomes in healthy older adults with mild to moderate subjective cognitive complaints. Seventy four participants will be randomised (1:1 ratio, matched by age, sex, and fibre intake) to Intervention or Placebo groups where they will be consuming a prebiotic fibre-fortified functional bakery product (containing 10g prebiotic fibre/day) or a regular bakery product (containing 0g prebiotic fibre/day), respectively, 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, immediate and delayed verbal memory, executive functions; affective measures of depression and anxiety symptomatology; gastrointestinal symptomatology; inflammatory measure of high sensitivity C-reactive protein (hs-CRP); metabolic measures of lipid profiles (total-C, LDL-C, HDL-C, triglycerides), Hemoglobin A1c (HbA1c) and systolic and diastolic blood pressure; and anthropometric measures of height, weight, hip and waist circumference.

Conditions

• Cognition
• Affect (Mental Function)
• C Reactive Protein

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Prebiotic fibre fortified bread roll	Subjects will consume a prebiotic fibre-fortified bread roll (10g of added prebiotic fibre/day).
DIETARY_SUPPLEMENT	Regular bread roll	Subjects will consume a regular bread roll (0g of added prebiotic fibre blend/day).

Timeline

• Start date: 2025-05-01
• Primary completion: 2026-02-20
• Completion: 2026-02-20
• First posted: 2025-01-28
• Last updated: 2026-03-04

Locations

1 site across 1 country: United Kingdom