An interventional study of ETAS® and Placebo in Cognition, Affect (Mental Function) and Sleep, sponsored by University of Reading. Recruiting at 1 site in United Kingdom. Open to participants aged 60 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-24.
Sponsored by University of Reading · Not applicable, Interventional, and Basic science
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.
243 studies on the registry are indexed under Language; 76 are open to participants now.
This study's planned enrollment of 60 is close to the median of 65 across 158 interventional studies indexed under Language.
Browse Language studies →University of Reading is the lead sponsor of 150 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will consume 1500mg ETAS®/day (capsule).
Dietary Supplement: ETAS®
Subjects will consume a matched placebo capsule.
Dietary Supplement: Placebo
1500mg ETAS®
Matched placebo capsule
Montreal 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)
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)
Telephone Interview for Cognitive Status-40
A questionnaire that assesses cognitive status. It will be used to screen participants.
Time frame: Baseline (pre intervention)
Gut microbiome diversity
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)
Gut microbiome composition
In a random subsample of participants, 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)
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for May 2026; primary completion for Dec 2027, 19 months later.
Of 89 non-industry interventional studies with no phase under Language, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 64. This study's planned 19 months is below that.
Counting every sponsor, half of 93 studies reached it within 33 months; a quarter within 17 and three quarters within 64.
How these figures are worked out, and which studies are left out of them.
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