This study aims to investigate the chronic effects of ETAS® on cognitive, affective and neural outcomes in healthy adults aged 60-80 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 12-week-long ETAS® consumption on affective, inflammatory, metabolic, and anthropometric outcomes in healthy older adults with mild to moderate subjective cognitive complaints. Sixty participants will be randomised to Intervention or Placebo groups where they will be consuming capsules containing 1500mg ETAS® or placebo, 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, executive function, and language/memory; affective measures of depression and anxiety symptomatology; and sleep; gastrointestinal symptomatology ; systolic and diastolic blood pressure, as well as height, weight, hip and waist circumference. Brain structure, function, and chemistry at both time points. Furthermore, random selection of participants (n=30, 15 in each group) will receive at home stool sample collection kits and microbiome diversity and compoisiton will be analysed at two time points.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
60
University of Reading, School of Psychology and Clinical Languages
Reading, Berkshire, United Kingdom
RECRUITINGMontreal Cognitive Assessment (MoCA) score
Composite measure of global cognitive function
Time frame: From baseline (pre intervention) to week 12 (post intervention)
fMRI
Functional brain activity will be analysed during cognitive tasks.
Time frame: From baseline (pre intervention) to week 12 (post intervention)
MRS
MRS will be used to assess neurochemistry of the medial temporal lobe and medial frontal cortex at rest.
Time frame: From baseline (pre intervention) to week 12 (post intervention)
Pittsburgh Sleep Quality Index Scores
A validated self-report measure of sleep quality.
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)
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)
Brain structure
Grey and white matter volume analysis of the brain will be conducted.
Time frame: From baseline (pre intervention) to week 12 (post intervention)
Patient Healthcare Questionnaire 8 (PHQ-8)
A validated self-report measure of depressive symptoms that includes 8-items
Time frame: From baseline (pre intervention) to week 12 (post intervention)
Generalised anxiety disorder 7 item scale (GAD-7)
A validated self-report measure of anxiety symptoms that includes 7-items
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.
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)
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 Body Mass Index in kg/m\^2.
Time frame: From baseline (pre intervention) to week 12 (post intervention)