Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
74 participants
INTERVENTIONAL
2025-05-01
2026-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
QUADRUPLE
Study Groups
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Active: Prebiotic fibre-fortified bread roll
Subjects will consume a prebiotic fibre-fortified bread roll (10g of added prebiotic fibre/day).
Prebiotic fibre fortified bread roll
Subjects will consume a prebiotic fibre-fortified bread roll (10g of added prebiotic fibre/day).
Placebo: Regular bread roll
Subjects will consume a regular bread roll (0g of added prebiotic fibre blend/day).
Regular bread roll
Subjects will consume a regular bread roll (0g of added prebiotic fibre blend/day).
Interventions
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Prebiotic fibre fortified bread roll
Subjects will consume a prebiotic fibre-fortified bread roll (10g of added prebiotic fibre/day).
Regular bread roll
Subjects will consume a regular bread roll (0g of added prebiotic fibre blend/day).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
60 Years
75 Years
ALL
Yes
Sponsors
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Innovate UK
OTHER_GOV
Biotechnology and Biological Sciences Research Council
OTHER
Myota Limited
UNKNOWN
Puratos Limited
UNKNOWN
Thriva Limited
UNKNOWN
University of Reading
OTHER
Responsible Party
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Piril Hepsomali
Principle Investigator
Locations
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University of Reading, School of Psychology and Clinical Languages
Reading, Berkshire, United Kingdom
Countries
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Other Identifiers
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UREC 24/36
Identifier Type: -
Identifier Source: org_study_id
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