BiomeBakery Project

NCT06796712 | Completed

• 1 other identifier: UREC 24/36
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cognition; Affect (Mental Function); C Reactive Protein

Keywords

prebiotics; fibre; cognition; depression; anxiety; inflammation

Outcome Measures

Primary Outcomes (2)

• Montreal Cognitive Assessment score

  Composite measure of global cognitive function - the total possible score is 30 points; a score of 26 or above is considered normal.

  From baseline (pre intervention) to week 12 (post intervention)

• hs-CRP levels

  High- sensitivity C-Reactive protein (hs-CRP) levels in plasma samples

  From baseline (pre intervention) to week 12 (post intervention)

Secondary Outcomes (13)

• Immediate Word Recall from the Rey Auditory Verbal Learning Task

  From baseline (pre intervention) to week 12 (post intervention)

• Delayed Word Recall from the Rey Auditory Verbal Learning Task

  From baseline (pre intervention) to week 12 (post intervention)

• Word Recognition from the Rey Auditory Verbal Learning Task

  From baseline (pre intervention) to week 12 (post intervention)

• EPIC Norfolk Food Frequency Questionnaire (FFQ)

  From baseline (pre intervention) to week 12 (post intervention)

• Working Memory Questionnaire Score

  From baseline (pre intervention) to week 12 (post intervention)

Other Outcomes (2)

• FiberScreen Scores

  Baseline (pre intervention)

• Telephone Interview for Cognitive Status-40

  Baseline (pre intervention)

Study Arms (2)

Active: Prebiotic fibre-fortified bread roll

EXPERIMENTAL

Subjects will consume a prebiotic fibre-fortified bread roll (10g of added prebiotic fibre/day).

Dietary Supplement: Prebiotic fibre fortified bread roll

Placebo: Regular bread roll

PLACEBO COMPARATOR

Subjects will consume a regular bread roll (0g of added prebiotic fibre blend/day).

Dietary Supplement: Regular bread roll

Interventions

Regular bread roll DIETARY_SUPPLEMENT

Subjects will consume a regular bread roll (0g of added prebiotic fibre blend/day).

Placebo: Regular bread roll

Prebiotic fibre fortified bread roll DIETARY_SUPPLEMENT

Subjects will consume a prebiotic fibre-fortified bread roll (10g of added prebiotic fibre/day).

Active: Prebiotic fibre-fortified bread roll

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aging between 60-75 years old
• Having normal vision and hearing
• Having a normal body mass index (BMI\<30)
• Having mild to moderate subjective cognitive complaints
• Consuming bread (5 or more times a week)

You may not qualify if:

• Smoking
• Having food allergies
• Following restrictive and/or unbalanced diets
• Changing dietary intake majorly in past month
• Being diagnosed with any psychiatric or neurologic conditions (e.g. schizophrenia, depression, dementia) including eating disorders
• Being diagnosed with any cardiometabolic diseases (including type II diabetes and cardiovascular disease), or suffering from hypertension or thrombosis related disorders or suffer from thyroid disease
• Being anaemic
• Currently taking anticoagulants, antiplatelet medication, antidepressants, proton-pump inhibitors
• Currently consuming prebiotic or probiotic supplements
• Continuous antibiotic use for \> 3 days within 1 month prior to enrolment
• Continuous use of weight-loss drug for \> 1 month before screening
• Having a significant gastrointestinal (GI) condition affecting absorption including (but not limited to) inflammatory bowel disease; total colectomy or bariatric surgery; irritable bowel disease; end stage renal disease; active cancer, or treatment for any cancer, in last 3 years
• Having a high fibre intake defined as \> 20g of fibre/day
• Wheat and/or gluten intolerance and having coeliac disease

Sponsors & Collaborators

• University of Reading: lead
• Innovate UK: collaborator
• Myota Limited: collaborator
• Puratos Limited: collaborator
• Thriva Limited: collaborator
• Biotechnology and Biological Sciences Research Council: collaborator

Study Sites (1)

University of Reading, School of Psychology and Clinical Languages

Reading, Berkshire, RG6 6BZ, United Kingdom

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Inflammation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: January 28, 2025
• Study Start: May 1, 2025
• Primary Completion: February 20, 2026
• Study Completion: February 20, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)