ETASCAI Pilot Project

November 18, 2025 updated by: Piril Hepsomali, University of Reading

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

45

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 Locations

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

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 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
  • 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

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: Active 1: ETAS® (300mg)
Subjects will consume 300mg ETAS®/day (capsule).
Dietary supplement: Active 1 ETAS®
300 mg ETAS®
Active Comparator: Active 1: ETAS® (1500mg)
Subjects will consume 1500mg ETAS®/day (capsule).
Dietary supplement: Active 2 ETAS®
1500mg ETAS®
Placebo Comparator: Placebo: 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)
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
From baseline (pre intervention) to week 12 (post intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Behaviour Rating Inventory of Executive Function Score
Time Frame: From baseline (pre intervention) to week 12 (post intervention)
A validated questionnaire that measures inhibition, self-monitoring, planning, task monitoring, emotional control, working memory and organisation of materials.
From baseline (pre intervention) to week 12 (post intervention)
Cognitive Failures Questionnaire Score
Time Frame: From baseline (pre intervention) to week 12 (post intervention)
A validated questionnaire that measures episodes of absent-mindedness, including slow performance on focused attention tasks.
From baseline (pre intervention) to week 12 (post intervention)
Geriatric Depression Scale scores
Time Frame: From baseline (pre intervention) to week 12 (post intervention)
A validated self-report measure of depression that includes 15-items.
From baseline (pre intervention) to week 12 (post intervention)
Geriatric Anxiety Inventory scores
Time Frame: From baseline (pre intervention) to week 12 (post intervention)
A validated self-report measure of anxiety that includes 20-items.
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)
A validated self-report measure of sleep quality.
From baseline (pre intervention) to week 12 (post intervention)
WHOQOL-BREF score
Time Frame: From baseline (pre intervention) to week 12 (post intervention)
A validated measure of quality of life
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)
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. Only individuals who score between 6 and 20 (depicting mild to moderate subjective cognitive complaints) will be included in the study.
Baseline (pre 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 (Actual)

February 24, 2025

Primary Completion (Actual)

October 22, 2025

Study Completion (Actual)

October 22, 2025

Study Registration Dates

First Submitted

January 13, 2025

First Submitted That Met QC Criteria

January 23, 2025

First Posted (Actual)

January 24, 2025

Study Record Updates

Last Update Posted (Actual)

November 19, 2025

Last Update Submitted That Met QC Criteria

November 18, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UREC 24_39

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

product manufactured in and exported from the U.S.

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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