CognitionNCT06790849
ETASCAI Pilot Project
A study testing Active 1 ETAS® and Active 2 ETAS® in people with Cognition and Affect (Mental Function), run by University of Reading at 1 site in United Kingdom.
Trial summary
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. 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), Inflammation
- What is being tested?
- Active 1 ETAS® and Active 2 ETAS®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Feb 2025to 22 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 or intolerances
- Following restrictive and/or unbalanced diets
- Changing dietary intake majorly in past month
- 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 suffering from hypertension or thrombosis related disorders or suffer from thyroid disease
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- Being anaemic
- Currently taking anticoagulants, antiplatelet medication, antidepressants, proton-pump inhibitors
- 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 inflammatory bowel disease; coeliac disease; total colectomy or bariatric surgery; irritable bowel disease; end stage renal disease; active cancer, or treatment for any cancer, in last 3 years
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Reading, School of Psychology and Clinical Languages
Reading, Berkshire, RG6 6ES
About this study
Official title: The Impact of Chronic Consumption of ETAS® for 12 Weeks on Cognitive, Affective, and Inflammatory Outcomes: A Randomised Parallel Group Placebo-controlled Feasibility Study
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.
Read the detailed description
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.
- Conditions
- Cognition, Affect (Mental Function), Inflammation
- Being tested
- Active 1 ETAS®, Active 2 ETAS®, Placebo
- Keywords
- ETAS®, cognition, depression, anxiety, sleep, quality of life, inflammation, tau
- Medical subject headings
- Inflammation, Depression, Anxiety Disorders, Pick Disease of the Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active 1 ETAS®Dietary supplement
300 mg ETAS®
Active 2 ETAS®Dietary supplement
1500mg ETAS®
PlaceboDietary supplement
Matched placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| Active 1: ETAS® (300mg) | Experimental | Subjects will consume 300mg ETAS®/day (capsule). Receives: Dietary Supplement: Active 1 ETAS® |
| Active 1: ETAS® (1500mg) | Active comparator | Subjects will consume 1500mg ETAS®/day (capsule). Receives: Dietary Supplement: Active 2 ETAS® |
| Placebo: 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)
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
Measured: From baseline (pre intervention) to week 12 (post intervention)
Secondary outcomes (11)
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.
Measured: 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.
Measured: From baseline (pre intervention) to week 12 (post intervention)
Geriatric Depression Scale scores
A validated self-report measure of depression that includes 15-items.
Measured: From baseline (pre intervention) to week 12 (post intervention)
Geriatric Anxiety Inventory scores
A validated self-report measure of anxiety that includes 20-items.
Measured: From baseline (pre intervention) to week 12 (post intervention)
Pittsburgh Sleep Quality Index Scores
A validated self-report measure of sleep quality.
Measured: From baseline (pre intervention) to week 12 (post intervention)
WHOQOL-BREF score
A validated measure of quality of life
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)
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 Jan 2025
- Study start24 Feb 2025
- Primary completion22 Oct 2025
- Study completion22 Oct 2025
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
- 45 participants (actual)
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
- NCT06790849
- Sponsor's protocol ID
- UREC 24_39
- Status last verified
- Mar 2025
- First submitted
- 13 Jan 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Chronic Consumption of ETAS® for 12 Weeks on Cognitive, Affective, and Inflammatory Outcomes: A Randomised Parallel Group Placebo-controlled Feasibility Study
- ClinicalTrials.gov ID
- NCT06790849
- Acronym / sponsor ID
- UREC 24_39
- Conditions
- Cognition, Affect (Mental Function), Inflammation
- Keywords
- ETAS®, cognition, depression, anxiety, sleep, quality of life, inflammation, tau
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Collaborators
- Amino Up Chemicals Co., Ltd.
- Study start
- 24 Feb 2025 (actual)
- Primary completion
- 22 Oct 2025 (actual)
- Study completion
- 22 Oct 2025 (actual)
- First posted
- 24 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active 1: ETAS® (300mg) | Experimental | Dietary Supplement: Active 1 ETAS®Subjects will consume 300mg ETAS®/day (capsule). |
| Active 1: ETAS® (1500mg) | Active comparator | Dietary Supplement: Active 2 ETAS®Subjects will consume 1500mg ETAS®/day (capsule). |
| Placebo: Matched placebo | Placebo comparator | Dietary Supplement: PlaceboSubjects will consume a matched placebo capsule. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- Smoking
- Having food allergies or intolerances
- Following restrictive and/or unbalanced diets
- Changing dietary intake majorly in past month
- Being diagnosed with any psychiatric or neurologic conditions (e.g. schizophrenia, depression, dementia) including eating disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active 1 ETAS®300 mg ETAS® | Dietary supplement | Active 1: ETAS® (300mg) |
| Active 2 ETAS®1500mg ETAS® | Dietary supplement | Active 1: ETAS® (1500mg) |
| PlaceboMatched placebo capsule | Dietary supplement | Placebo: Matched placebo |
Primary outcome
Montreal Cognitive Assessment (MoCA) score
Time frame: From baseline (pre intervention) to week 12 (post intervention)
Composite measure of global cognitive function
Inflammatory biomarker levels
Time frame: From baseline (pre intervention) to week 12 (post intervention)
IFN-γ, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, IL-13, TNF-α, CRP levels from plasma
11 secondary outcomes
Behaviour Rating Inventory of Executive Function Score
Time frame: From baseline (pre intervention) to week 12 (post intervention)
Cognitive Failures Questionnaire Score
Time frame: From baseline (pre intervention) to week 12 (post intervention)
Geriatric Depression Scale scores
Time frame: From baseline (pre intervention) to week 12 (post intervention)
Geriatric Anxiety Inventory scores
Time frame: From baseline (pre intervention) to week 12 (post intervention)
Pittsburgh Sleep Quality Index Scores
Time frame: From baseline (pre intervention) to week 12 (post intervention)
WHOQOL-BREF score
Time frame: From baseline (pre intervention) to week 12 (post intervention)
Gastrointestinal Symptom Rating Scale Scores
Time frame: From baseline (pre intervention) to week 12 (post intervention)
EPIC Norfolk Food Frequency Questionnaire (FFQ)
Time frame: From baseline (pre intervention) to week 12 (post intervention)
Blood Pressure
Time frame: From baseline (pre intervention) to week 12 (post intervention)
Hip and waist circumference
Time frame: From baseline (pre intervention) to week 12 (post intervention)
Body Mass Index
Time frame: From baseline (pre intervention) to week 12 (post intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active 1 ETAS® and Active 2 ETAS® in people with Cognition and Affect (Mental Function), run by University of Reading at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montreal Cognitive Assessment (MoCA) score (time frame: From baseline (pre intervention) to week 12 (post intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.