ETASCAN Project: ETAS Project 2

NCT07550140 | Recruiting

• 1 other identifier: 2025-229-PH
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

fMRI; Magnetic Resonance Spectroscopy; Cognition; Affect (Mental Function); Sleep; MRI

Keywords

grey matter; brain structure; brain function; neurochemistry; executive function; language; ETAS®; depression; anxiety; sleep; gut microbiome

Outcome Measures

Primary Outcomes (3)

• Montreal Cognitive Assessment (MoCA) score

  Composite measure of global cognitive function

  From baseline (pre intervention) to week 12 (post intervention)

• fMRI

  Functional brain activity will be analysed during cognitive tasks.

  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.

  From baseline (pre intervention) to week 12 (post intervention)

Secondary Outcomes (11)

• Pittsburgh Sleep Quality Index Scores

  From baseline (pre intervention) to week 12 (post intervention)

• Immediate Word Recall from the Rey Auditory Verbal Learning Task

  From baseline (pre intervention) to week 12 (post intervention)

• Delayed Word Recall from the Rey Auditory Verbal Learning Task

  From baseline (pre intervention) to week 12 (post intervention)

• Gastrointestinal Symptom Rating Scale Scores

  From baseline (pre intervention) to week 12 (post intervention)

• Brain structure

  From baseline (pre intervention) to week 12 (post intervention)

Other Outcomes (3)

• Telephone Interview for Cognitive Status-40

  Baseline (pre intervention)

• Gut microbiome diversity

  From baseline (pre intervention) to week 12 (post intervention)

• Gut microbiome composition

  From baseline (pre intervention) to week 12 (post intervention)

Study Arms (2)

ETAS® (1500mg)

EXPERIMENTAL

Subjects will consume 1500mg ETAS®/day (capsule).

Dietary Supplement: ETAS®

Matched placebo

PLACEBO COMPARATOR

Subjects will consume a matched placebo capsule.

Dietary Supplement: Placebo

Interventions

ETAS® DIETARY_SUPPLEMENT

1500mg ETAS®

ETAS® (1500mg)

Placebo DIETARY_SUPPLEMENT

Matched placebo capsule

Matched placebo

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Reading: lead
• Amino Up Chemicals Co., Ltd.: collaborator

Study Sites (1)

University of Reading, School of Psychology and Clinical Languages

Reading, Berkshire, RG6 6ES, United Kingdom

RECRUITING

MeSH Terms

Conditions

Language; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Communication; Behavior; Behavioral Symptoms; Mental Disorders

Central Study Contacts

Piril Hepsomali, PhD

CONTACT

+44 118 378 5818; p.hepsomali@reading.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: April 24, 2026
• Study Start: May 5, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)