This pilot study aims to investigate the chronic effects of a prebiotic blend on cognitive, affective and gut microbiome outcomes in healthy adults aged 60-75 years.
This pilot study will employ a double-blind, randomised, placebo-controlled parallel design to investigate the chronic effects of 12-week-long prebiotic blend consumption on cognitive, affective, gut microbiome, metabolic, and anthropometric outcomes in healthy older adults with mild to moderate subjective cognitive complaints. Fifty participants will be randomised to Intervention or Placebo groups where they will be consuming 10g of prebiotic fibre blend or 10g of placebo (matched placebo powder) per day 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, and domain-specific cognitive performance, affective measures of depression and anxiety symptomatology; gastrointestinal symptomatology; systolic and diastolic blood pressure, as well as height, weight, hip and waist circumference. In addition, stool samples will be collected at all timepoints to assess microbiome diversity and composition.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
50
10g of prebiotic fibre blend powder
10g of matched placebo powder
University of Reading, School of Psychology and Clinical Languages
Reading, Berkshire, United Kingdom
Cognitive Drug Research Computerized Assessment System (COGDRAS) scores
The COGDRAS battery consists of 8 individual cognitive tests testing memory, attention and reaction times.
Time frame: From baseline (pre intervention) to week 12 (post intervention)
Gut microbiome diversity
Stool samples will be collected to measure gut microbiome diversity. Indices of alpha and beta diversity will be analysed (16s sequencing).
Time frame: From baseline (pre intervention) to week 12 (post intervention)
Gut microbiome composition
Stool samples will be collected to measure gut microbiome composition (genus and species) (16s sequencing).
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)
Montreal Cognitive Assessment (MoCA) score
Composite measure of global cognitive function
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) .
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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)
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)
Hip and waist circumference
Hip and waist circumference (in cm) will be measured.
Time frame: From baseline (pre intervention) to week 12 (post intervention)
Body Mass Index
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)