CognitionETASCANNCT07550140
ETASCAN Project: ETAS Project 2
A study testing ETAS® in people with Cognition and Affect (Mental Function), run by University of Reading at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognition, Affect (Mental Function), Sleep
- What is being tested?
- ETAS®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 May 2026to 31 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aging between 60-80 years old
- Having normal vision and hearing
- Having a body mass index between 18.5 and 30
- Having mild to moderate subjective cognitive complaints
Who cannot join
- Smoking
- Having food allergies
- Following restrictive and/or unbalanced diets (Appendix 6: Are you vegetarian or vegan? Yes / No; Are you currently on a weight-reducing or other special diet? Yes/No If 'Yes', please give details.)
- Being diagnosed with any psychiatric or neurologic conditions (e.g. schizophrenia, depression, dementia) including eating disorders
- Being diagnosed with any cardiometabolic diseases (including type II diabetes and cardiovascular disease), or hypertension or thrombosis related disorders or suffer from thyroid disease
- Currently taking anticoagulants, antiplatelet medication, antidepressants, proton-pump inhibitors
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- Currently consuming prebiotic or probiotic supplements
- Continuous antibiotic use for > 3 days within 1 month prior to enrolment
- Continuous use of weight-loss drug for > 1 month before screening
- Having a significant gastrointestinal (GI) condition affecting absorption including (but not limited to) inflammatory bowel disease; total colectomy or bariatric surgery; irritable bowel disease; end stage renal disease; active cancer, or treatment for any cancer, in last 3 years
- History of claustrophobia
- Fitted with a pacemaker or artificial heart valve
- Have active implants, such as cochlear, ocular, or penile implant
- Experience of metal fragments e.g. shrapnel in your eyes or any other part of your body
- Drug infusion pump installed
- Have any surgically implanted metal in any part of your body, other than dental fillings and crowns (e.g. joint replacement or bone re-construction)
- Have had any surgery that might have involved metal implants
- Current or historical experience of epilepsy
- Have stimulators for nerves, brain or bone installed
- Have an intrauterine contraceptive device installed (IUD)
- Wear transdermal patches containing metal
- Wear a filling, crown, dental post (entirely within the tooth) associated with root canal treatment, retainer, bridge or braces
- For scanning, would need to remove coloured contact lenses, nail polish and makeup.
- Hearing aid wearer
- Body piercings that you cannot or will not remove for the scanning session
- Have tattoos or permanent makeup
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Reading, School of Psychology and Clinical Languages
Reading, Berkshire, RG6 6ES
Piril Hepsomali, PhD, +44 118 378 5818, p.hepsomali@reading.ac.uk
About this study
Official title: The Impact of Chronic Consumption of ETAS® for 12 Weeks on Cognitive, Affective, and Neural Outcomes: A Randomised Parallel Group Placebo-controlled Study
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.
Read the detailed description
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.
- Conditions
- Cognition, Affect (Mental Function), Sleep, MRI, fMRI, Magnetic Resonance Spectroscopy
- Being tested
- ETAS®, Placebo
- Keywords
- grey matter, brain structure, brain function, neurochemistry, executive function, language, ETAS®, depression, anxiety, sleep, gut microbiome
- Medical subject headings
- Language, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ETAS®Dietary supplement
1500mg ETAS®
PlaceboDietary supplement
Matched placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| ETAS® (1500mg) | Experimental | Subjects will consume 1500mg ETAS®/day (capsule). Receives: Dietary Supplement: ETAS® |
| Matched placebo | Placebo comparator | Subjects will consume a matched placebo capsule. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal Cognitive Assessment (MoCA) score
Composite measure of global cognitive function
Measured: From baseline (pre intervention) to week 12 (post intervention)
fMRI
Functional brain activity will be analysed during cognitive tasks.
Measured: 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.
Measured: From baseline (pre intervention) to week 12 (post intervention)
Secondary outcomes (11)
Pittsburgh Sleep Quality Index Scores
A validated self-report measure of sleep quality.
Measured: 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.
Measured: 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
Measured: 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)
Measured: From baseline (pre intervention) to week 12 (post intervention)
Brain structure
Grey and white matter volume analysis of the brain will be conducted.
Measured: 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
Measured: 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
Measured: 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.
Measured: From baseline (pre intervention) to week 12 (post intervention)
Blood Pressure
Systolic and diastolic blood pressure (in mmHg) will be measured.
Measured: From baseline (pre intervention) to week 12 (post intervention)
Hip and waist circumference
Hip and waist circumference (in cm) will be measured.
Measured: 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.
Measured: From baseline (pre intervention) to week 12 (post intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start5 May 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CognitionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Collaborators
- Amino Up Chemicals Co., Ltd.
- Responsible party
- Principal investigator, Piril Hepsomali, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07550140
- Sponsor's protocol ID
- 2025-229-PH
- Acronym
- ETASCAN
- Status last verified
- Apr 2026
- First submitted
- 17 Apr 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No