This pilot study aims to investigate the chronic effects of ETAS® on cognitive, affective and inflammatory outcomes in healthy adults aged 60-80 years with mild to moderate subjective cognitive complaints.
This pilot 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. Thirty participants will be randomised to Intervention 1, Intervention 2, or Placebo groups where they will be consuming capsules containing 300mg ETAS®, 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 cognitive failures; affective measures of depression and anxiety symptomatology; quality of life, and sleep; gastrointestinal symptomatology; inflammatory measures of IFN-γ, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, IL-13, TNF-α, CRP; systolic and diastolic blood pressure, as well as height, weight, hip and waist circumference. In addition, tau from plasma will be recorded at all timepoints.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
45
300 mg ETAS®
1500mg ETAS®
Matched placebo capsule
University of Reading, School of Psychology and Clinical Languages
Reading, Berkshire, United Kingdom
Montreal Cognitive Assessment (MoCA) score
Composite measure of global cognitive function
Time frame: From baseline (pre intervention) to week 12 (post intervention)
Inflammatory biomarker levels
IFN-γ, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, IL-13, TNF-α, CRP levels from plasma
Time frame: From baseline (pre intervention) to week 12 (post intervention)
Behaviour Rating Inventory of Executive Function Score
A validated questionnaire that measures inhibition, self-monitoring, planning, task monitoring, emotional control, working memory and organisation of materials.
Time frame: From baseline (pre intervention) to week 12 (post intervention)
Cognitive Failures Questionnaire Score
A validated questionnaire that measures episodes of absent-mindedness, including slow performance on focused attention tasks.
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)
Pittsburgh Sleep Quality Index Scores
A validated self-report measure of sleep quality.
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Time frame: From baseline (pre intervention) to week 12 (post intervention)
WHOQOL-BREF score
A validated measure of quality of life
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)
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)