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Completed

NCT Number: NCT06790849

ETASCAI Pilot Project

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.

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Key information

Conditions

Cognition Affect (Mental Function) Anxiety Disorders Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Dementia Depression Frontotemporal Dementia Frontotemporal Lobar Degeneration Inflammation Mental Disorders Nervous System Diseases Neurocognitive Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Pick Disease of the Brain

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Reading, School of Psychology and Clinical Languages

Reading, Berkshire, RG6 6ES, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active 1 ETAS®

Dietary Supplement

300 mg ETAS®

Active 2 ETAS®

Dietary Supplement

1500mg ETAS®

Placebo

Dietary Supplement

Matched placebo capsule

Primary outcomes

  1. Montreal Cognitive Assessment (MoCA) score

    Time frame: From baseline (pre intervention) to week 12 (post intervention)

    Composite measure of global cognitive function

  2. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Pittsburgh Sleep Quality Index Scores

    Time frame: From baseline (pre intervention) to week 12 (post intervention)

    A validated self-report measure of sleep quality.

  6. WHOQOL-BREF score

    Time frame: From baseline (pre intervention) to week 12 (post intervention)

    A validated measure of quality of life

  7. 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)

  8. 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.

  9. Blood Pressure

    Time frame: From baseline (pre intervention) to week 12 (post intervention)

    Systolic and diastolic blood pressure (in mmHg) will be measured.

  10. Hip and waist circumference

    Time frame: From baseline (pre intervention) to week 12 (post intervention)

    Hip and waist circumference (in cm) will be measured.

  11. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Reading

Other

Collaborators

  • Amino Up Chemicals Co., Ltd.

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 24, 2025
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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