University of Reading, School of Psychology and Clinical Languages
Reading, Berkshire, RG6 6ES, United Kingdom
Location status: Recruiting
NCT Number: NCT07550140
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.
Interested in participating?
Request Info60 year–80 year
All sexes
Interventional
Not applicable
Reading, Berkshire, RG6 6ES, United Kingdom
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
1500mg ETAS®
Matched placebo capsule
Time frame: From baseline (pre intervention) to week 12 (post intervention)
Composite measure of global cognitive function
Time frame: From baseline (pre intervention) to week 12 (post intervention)
Functional brain activity will be analysed during cognitive tasks.
Time frame: From baseline (pre intervention) to week 12 (post intervention)
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)
A validated self-report measure of sleep quality.
Time frame: From baseline (pre intervention) to week 12 (post intervention)
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)
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)
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)
Grey and white matter volume analysis of the brain will be conducted.
Time frame: From baseline (pre intervention) to week 12 (post intervention)
A validated self-report measure of depressive symptoms that includes 8-items
Time frame: From baseline (pre intervention) to week 12 (post intervention)
A validated self-report measure of anxiety symptoms that includes 7-items
Time frame: From baseline (pre intervention) to week 12 (post intervention)
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)
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 (in cm) will be measured.
Time frame: From baseline (pre intervention) to week 12 (post intervention)
Weight (in kg) and height (in m) will be combined to report Body Mass Index in kg/m^2.
Time frame: Baseline (pre intervention)
A questionnaire that assesses cognitive status. It will be used to screen participants.
Time frame: From baseline (pre intervention) to week 12 (post intervention)
In a random subsample of participants, 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)
In a random subsample of participants, stool samples will be collected to measure gut microbiome composition (genus and species) (16s sequencing).
Contact information is provided by the study sponsor or research team.
University of Reading
Other
The Impact of Chronic Consumption of ETAS® for 12 Weeks on Cognitive, Affective, and Neural Outcomes: A Randomised Parallel Group Placebo-controlled Study
Acronym: ETASCAN
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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