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.
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
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
74
Subjects will consume a prebiotic fibre-fortified bread roll (10g of added prebiotic fibre/day).
Subjects will consume a regular bread roll (0g of added prebiotic fibre blend/day).
University of Reading, School of Psychology and Clinical Languages
Reading, Berkshire, United Kingdom
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.
Time frame: From baseline (pre intervention) to week 12 (post intervention)
hs-CRP levels
High- sensitivity C-Reactive protein (hs-CRP) levels in plasma samples
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
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Time frame: From baseline (pre intervention) to week 12 (post intervention)
Working Memory Questionnaire Score
A measure assessing short-term storage, attention, and executive control
Time frame: 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) .
Time frame: From baseline (pre intervention) to week 12 (post intervention)
Geriatric Depression Scale scores
A validated self-report measure of depression that includes 15-items.
Time frame: From baseline (pre intervention) to week 12 (post intervention)
Geriatric Anxiety Inventory scores
A validated self-report measure of anxiety that includes 20-items.
Time frame: From baseline (pre intervention) to week 12 (post intervention)
Positive and Negative Affect Schedule (PANAS)
A 20-item questionnaire measuring positive and negative affect.
Time frame: 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.
Time frame: From baseline (pre intervention) to week 12 (post intervention)
Hemoglobin A1c (HbA1c)
Hemoglobin A1c (HbA1c) will be assessed.
Time frame: From baseline (pre intervention) to week 12 (post intervention)
Blood Pressure
Systolic and diastolic blood pressure (in mmHg) will be measured.
Time frame: 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.
Time frame: From baseline (pre intervention) to week 12 (post intervention)