AzTrials
AzTrials

CognitionNCT06796712

BiomeBakery Project

A study testing Prebiotic fibre fortified bread roll and Regular bread roll in people with Cognition and Affect (Mental Function), run by University of Reading at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 60 to 75 yearsHealthy volunteers can take part
What is being tested?
Prebiotic fibre fortified bread roll and Regular bread roll
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
55 participants
Where
1 siteUnited Kingdom
Study dates
1 May 2025to 20 Feb 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • University of Reading, School of Psychology and Clinical Languages

    Reading, Berkshire, RG6 6BZ

Other trials in United Kingdom

About this study

Official title: 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.

Read the 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.

Being tested
Prebiotic fibre fortified bread roll, Regular bread roll
Keywords
prebiotics, fibre, cognition, depression, anxiety, inflammation
Medical subject headings
Depression, Anxiety Disorders, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prebiotic fibre fortified bread rollDietary supplement

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

  • Regular bread rollDietary supplement

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

Study groups in NCT06796712
Study groupRoleWhat they receive
Active: Prebiotic fibre-fortified bread rollExperimentalSubjects will consume a prebiotic fibre-fortified bread roll (10g of added prebiotic fibre/day).
Receives: Dietary Supplement: Prebiotic fibre fortified bread roll
Placebo: Regular bread rollPlacebo comparatorSubjects will consume a regular bread roll (0g of added prebiotic fibre blend/day).
Receives: Dietary Supplement: Regular bread roll

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. hs-CRP levels

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

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

Secondary outcomes (13)

  1. 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.

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

  2. 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

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

  3. 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.

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

  4. 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.

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

  5. Working Memory Questionnaire Score

    A measure assessing short-term storage, attention, and executive control

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

  6. 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) .

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

  7. Geriatric Depression Scale scores

    A validated self-report measure of depression that includes 15-items.

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

  8. Geriatric Anxiety Inventory scores

    A validated self-report measure of anxiety that includes 20-items.

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

  9. Positive and Negative Affect Schedule (PANAS)

    A 20-item questionnaire measuring positive and negative affect.

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

  10. Lipid profiles

    Total-Cholesterol, Low-density lipoprotein cholesterol (LDL-C), High-density lipoprotein cholesterol (HDL-C), and triglycerides will be assessed.

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

  11. Hemoglobin A1c (HbA1c)

    Hemoglobin A1c (HbA1c) will be assessed.

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

  12. Blood Pressure

    Systolic and diastolic blood pressure (in mmHg) will be measured.

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

  13. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2025
  2. Study start1 May 2025
  3. Primary completion20 Feb 2026
  4. Study completion20 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06796712
Sponsor's protocol ID
UREC 24/36
Status last verified
Jan 2026
First submitted
22 Jan 2025
Last updated
4 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lee Y, Colombage RL, Hall CV, Lamport DJ, Williams CM, Hepsomali P. Effects of a prebiotic fibre-enriched bread in older adults: a randomised, placebo-controlled, parallel-groups feasibility study (BiomeBakery). J Nutr Health Aging. 2026 Aug 13;30(10):100939. doi: 10.1016/j.jnha.2026.100939. Online ahead of print.

    PubMed 42594505

Questions about this trial

What is this clinical trial studying?

A study testing Prebiotic fibre fortified bread roll and Regular bread roll in people with Cognition and Affect (Mental Function), run by University of Reading at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Montreal Cognitive Assessment score (time frame: From baseline (pre intervention) to week 12 (post intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06796712, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in