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

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.

Study Overview

• Status: Completed
• Conditions: Cognition; C Reactive Protein; Affect (Mental Function)
• Intervention / Treatment: Dietary supplement: Prebiotic fibre fortified bread roll; Dietary supplement: Regular bread roll

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.

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Berkshire
    • Reading, Berkshire, United Kingdom, RG6 6BZ
      • University of Reading, School of Psychology and Clinical Languages

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active: Prebiotic fibre-fortified bread roll; Subjects will consume a prebiotic fibre-fortified bread roll (10g of added prebiotic fibre/day).	Dietary supplement: Prebiotic fibre fortified bread roll; Subjects will consume a prebiotic fibre-fortified bread roll (10g of added prebiotic fibre/day).
Placebo Comparator: Placebo: Regular bread roll; Subjects will consume a regular bread roll (0g of added prebiotic fibre blend/day).	Dietary supplement: Regular bread roll; Subjects will consume a regular bread roll (0g of added prebiotic fibre blend/day).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hs-CRP levels	High- sensitivity C-Reactive protein (hs-CRP) levels in plasma samples	From baseline (pre intervention) to week 12 (post intervention)
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geriatric Depression Scale scores	A validated self-report measure of depression that includes 15-items.	From baseline (pre intervention) to week 12 (post intervention)
Geriatric Anxiety Inventory scores	A validated self-report measure of anxiety that includes 20-items.	From baseline (pre intervention) to week 12 (post intervention)
EPIC Norfolk Food Frequency Questionnaire (FFQ)	The FFQ is a validated tool for gauging the average habitual dietary intake of micro and macronutrients of an individual in the UK. Data will be processed using the FETA software.	From baseline (pre intervention) to week 12 (post intervention)
Blood Pressure	Systolic and diastolic blood pressure (in mmHg) will be measured.	From baseline (pre intervention) to week 12 (post intervention)
Immediate Word Recall from the Rey Auditory Verbal Learning Task	Participants will be presented with a sequential list of 15 words, at a rate of 1 word per second. The participant will then have 60s to say out loud as many of these words as possible, with the resulting score recorded as a percentage of accuracy.	From baseline (pre intervention) to week 12 (post intervention)
Delayed Word Recall from the Rey Auditory Verbal Learning Task	After a period of time subject are asked to recall as many words as possible from list A	From baseline (pre intervention) to week 12 (post intervention)
Word Recognition from the Rey Auditory Verbal Learning Task	Following the delayed word recall, words from list A, list B and novel words are displayed sequentially on the screen and participants are asked to indicate which words were from list A only.	From baseline (pre intervention) to week 12 (post intervention)
Working Memory Questionnaire Score	A measure assessing short-term storage, attention, and executive control	From baseline (pre intervention) to week 12 (post intervention)
Gastrointestinal Symptom Rating Scale Scores	A validated self-report measure of gastrointestinal symptoms that includes 15-items (combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation) .	From baseline (pre intervention) to week 12 (post intervention)
Positive and Negative Affect Schedule (PANAS)	A 20-item questionnaire measuring positive and negative affect.	From baseline (pre intervention) to week 12 (post intervention)
Lipid profiles	Total-Cholesterol, Low-density lipoprotein cholesterol (LDL-C), High-density lipoprotein cholesterol (HDL-C), and triglycerides will be assessed.	From baseline (pre intervention) to week 12 (post intervention)
Hemoglobin A1c (HbA1c)	Hemoglobin A1c (HbA1c) will be assessed.	From baseline (pre intervention) to week 12 (post intervention)
Anthropometric outcomes	Hip and waist circumference (in cm) will be measured. Additionally, weight (in kg) and height (in m) will be combined to report BMI in kg/m^2.	From baseline (pre intervention) to week 12 (post intervention)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Telephone Interview for Cognitive Status-40	A questionnaire that assesses cognitive status. It will be used to screen participants. Only individuals who score between 6 and 20 (depicting mild to moderate subjective cognitive complaints) will be included in the study.	Baseline (pre intervention)
FiberScreen Scores	A questionnaire that assesses fibre intake. It will be used to screen participants. Individuals who adhere to a high fibre diet (>20g fibre/day) will be excluded from the study.	Baseline (pre intervention)

Collaborators and Investigators

• Sponsor: University of Reading
• Collaborators: Biotechnology and Biological Sciences Research Council; Innovate UK; Myota Limited; Puratos Limited; Thriva Limited

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2025
• Primary Completion (Actual): February 20, 2026
• Study Completion (Actual): February 20, 2026

Study Registration Dates

• First Submitted: January 22, 2025
• First Submitted That Met QC Criteria: January 22, 2025
• First Posted (Actual): January 28, 2025

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: depression; cognition; anxiety; inflammation; prebiotics; fibre
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Behavioral Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Anxiety Disorders; Depression; Inflammation
• Other Study ID Numbers: UREC 24/36

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No