ETASCAN Project: ETAS Project 2 (ETASCAN)

April 17, 2026 updated by: Piril Hepsomali, University of Reading

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
    • Berkshire
      • Reading, Berkshire, United Kingdom, RG6 6ES
        • Recruiting
        • University of Reading, School of Psychology and Clinical Languages
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ETAS® (1500mg)
Subjects will consume 1500mg ETAS®/day (capsule).
Dietary supplement: ETAS®
1500mg ETAS®
Placebo Comparator: Matched placebo
Subjects will consume a matched placebo capsule.
Dietary supplement: Placebo
Matched placebo capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Montreal Cognitive Assessment (MoCA) score
Time Frame: From baseline (pre intervention) to week 12 (post intervention)
Composite measure of global cognitive function
From baseline (pre intervention) to week 12 (post intervention)
fMRI
Time Frame: From baseline (pre intervention) to week 12 (post intervention)
Functional brain activity will be analysed during cognitive tasks.
From baseline (pre intervention) to week 12 (post intervention)
MRS
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.
From baseline (pre intervention) to week 12 (post intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pittsburgh Sleep Quality Index Scores
Time Frame: From baseline (pre intervention) to week 12 (post intervention)
A validated self-report measure of sleep quality.
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)
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)
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)
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.
From baseline (pre intervention) to week 12 (post intervention)
Blood Pressure
Time Frame: From baseline (pre intervention) to week 12 (post intervention)
Systolic and diastolic blood pressure (in mmHg) will be measured.
From baseline (pre intervention) to week 12 (post intervention)
Hip and waist circumference
Time Frame: From baseline (pre intervention) to week 12 (post intervention)
Hip and waist circumference (in cm) will be measured.
From baseline (pre intervention) to week 12 (post intervention)
Immediate Word Recall from the Rey Auditory Verbal Learning Task
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.
From baseline (pre intervention) to week 12 (post intervention)
Delayed Word Recall from the Rey Auditory Verbal Learning Task
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
From baseline (pre intervention) to week 12 (post intervention)
Brain structure
Time Frame: From baseline (pre intervention) to week 12 (post intervention)
Grey and white matter volume analysis of the brain will be conducted.
From baseline (pre intervention) to week 12 (post intervention)
Patient Healthcare Questionnaire 8 (PHQ-8)
Time Frame: From baseline (pre intervention) to week 12 (post intervention)
A validated self-report measure of depressive symptoms that includes 8-items
From baseline (pre intervention) to week 12 (post intervention)
Generalised anxiety disorder 7 item scale (GAD-7)
Time Frame: From baseline (pre intervention) to week 12 (post intervention)
A validated self-report measure of anxiety symptoms that includes 7-items
From baseline (pre intervention) to week 12 (post intervention)
Body mass index
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.
From baseline (pre intervention) to week 12 (post intervention)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Telephone Interview for Cognitive Status-40
Time Frame: Baseline (pre intervention)
A questionnaire that assesses cognitive status. It will be used to screen participants.
Baseline (pre intervention)
Gut microbiome diversity
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).
From baseline (pre intervention) to week 12 (post intervention)
Gut microbiome composition
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).
From baseline (pre intervention) to week 12 (post intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Reading

Collaborators

Amino Up Chemicals Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 5, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

April 17, 2026

First Submitted That Met QC Criteria

April 17, 2026

First Posted (Actual)

April 24, 2026

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-229-PH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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