Clinical trial NCT06796712: BiomeBakery Project
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cognition
Affect (Mental Function)
C Reactive Protein
Keywords: prebiotics
fibre
cognition
depression
anxiety
inflammation
Lead sponsor: University of Reading
Sponsor class: OTHER
Collaborators: name: Innovate UK
name: Biotechnology and Biological Sciences Research Council
name: Myota Limited
name: Puratos Limited
name: Thriva Limited
First posted: 2025-01-28
Enrollment: 74
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Montreal Cognitive Assessment score
timeFrame: From baseline (pre intervention) to week 12 (post intervention)
measure: hs-CRP levels
timeFrame: From baseline (pre intervention) to week 12 (post intervention)
Secondary outcomes:
measure: Immediate Word Recall from the Rey Auditory Verbal Learning Task
timeFrame: From baseline (pre intervention) to week 12 (post intervention)
measure: Delayed Word Recall from the Rey Auditory Verbal Learning Task
timeFrame: From baseline (pre intervention) to week 12 (post intervention)
measure: Word Recognition from the Rey Auditory Verbal Learning Task
timeFrame: From baseline (pre intervention) to week 12 (post intervention)
measure: EPIC Norfolk Food Frequency Questionnaire (FFQ)
timeFrame: From baseline (pre intervention) to week 12 (post intervention)
measure: Working Memory Questionnaire Score
timeFrame: From baseline (pre intervention) to week 12 (post intervention)
measure: Gastrointestinal Symptom Rating Scale Scores
timeFrame: From baseline (pre intervention) to week 12 (post intervention)
measure: Geriatric Depression Scale scores
timeFrame: From baseline (pre intervention) to week 12 (post intervention)
measure: Geriatric Anxiety Inventory scores
timeFrame: From baseline (pre intervention) to week 12 (post intervention)
measure: Positive and Negative Affect Schedule (PANAS)
timeFrame: From baseline (pre intervention) to week 12 (post intervention)
measure: Lipid profiles
timeFrame: From baseline (pre intervention) to week 12 (post intervention)
measure: Hemoglobin A1c (HbA1c)
timeFrame: From baseline (pre intervention) to week 12 (post intervention)
measure: Blood Pressure
timeFrame: From baseline (pre intervention) to week 12 (post intervention)
measure: Anthropometric outcomes
timeFrame: From baseline (pre intervention) to week 12 (post intervention)
Other outcomes:
measure: FiberScreen Scores
timeFrame: Baseline (pre intervention)
measure: Telephone Interview for Cognitive Status-40
timeFrame: Baseline (pre intervention)
Locations:
city: Reading
country: United Kingdom
facility: University of Reading, School of Psychology and Clinical Languages
state: Berkshire
Study officials:
References: