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Completed

NCT Number: NCT06796712

BiomeBakery Project

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.

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Key information

Conditions

Cognition Affect (Mental Function) Anxiety Disorders Behavior Behavioral Symptoms C Reactive Protein Depression Inflammation Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

60 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Reading, School of Psychology and Clinical Languages

Reading, Berkshire, RG6 6BZ, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prebiotic fibre fortified bread roll

Dietary Supplement

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

Regular bread roll

Dietary Supplement

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

Primary outcomes

  1. Montreal Cognitive Assessment score

    Time frame: From baseline (pre intervention) to week 12 (post intervention)

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

  2. hs-CRP levels

    Time frame: From baseline (pre intervention) to week 12 (post intervention)

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

Secondary outcomes

  1. Immediate Word Recall from the Rey Auditory Verbal Learning Task

    Time frame: From baseline (pre intervention) to week 12 (post intervention)

    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.

  2. Delayed Word Recall from the Rey Auditory Verbal Learning Task

    Time frame: From baseline (pre intervention) to week 12 (post intervention)

    After a period of time subject are asked to recall as many words as possible from list A

  3. Word Recognition from the Rey Auditory Verbal Learning Task

    Time frame: From baseline (pre intervention) to week 12 (post intervention)

    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.

  4. EPIC Norfolk Food Frequency Questionnaire (FFQ)

    Time frame: From baseline (pre intervention) to week 12 (post intervention)

    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.

  5. Working Memory Questionnaire Score

    Time frame: From baseline (pre intervention) to week 12 (post intervention)

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

  6. Gastrointestinal Symptom Rating Scale Scores

    Time frame: From baseline (pre intervention) to week 12 (post intervention)

    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) .

  7. Geriatric Depression Scale scores

    Time frame: From baseline (pre intervention) to week 12 (post intervention)

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

  8. Geriatric Anxiety Inventory scores

    Time frame: From baseline (pre intervention) to week 12 (post intervention)

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

  9. Positive and Negative Affect Schedule (PANAS)

    Time frame: From baseline (pre intervention) to week 12 (post intervention)

    A 20-item questionnaire measuring positive and negative affect.

  10. Lipid profiles

    Time frame: From baseline (pre intervention) to week 12 (post intervention)

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

  11. Hemoglobin A1c (HbA1c)

    Time frame: From baseline (pre intervention) to week 12 (post intervention)

    Hemoglobin A1c (HbA1c) will be assessed.

  12. Blood Pressure

    Time frame: From baseline (pre intervention) to week 12 (post intervention)

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

  13. Anthropometric outcomes

    Time frame: From baseline (pre intervention) to week 12 (post intervention)

    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.

Other outcomes

  1. FiberScreen Scores

    Time frame: Baseline (pre intervention)

    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.

  2. Telephone Interview for Cognitive Status-40

    Time frame: Baseline (pre intervention)

    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.

Sponsors and collaborators

Lead sponsor

University of Reading

Other

Collaborators

  • Biotechnology and Biological Sciences Research Council
  • Innovate UK
  • Myota Limited
  • Puratos Limited
  • Thriva Limited

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 28, 2025
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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