Actively Recruiting

Phase Not Applicable
Age: 60Years - 80Years
All Genders
Healthy Volunteers
ID07550140

The Impact of Chronic Consumption of ETAS450mg for 12 Weeks on Cognitive, Affective, and Neural Outcomes in Older Adults: A Randomised Placebo-controlled Study

Led by University of Reading · Updated on 2026-04-24

60

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Reading

Lead Sponsor

A

Amino Up Chemicals Co., Ltd.

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating the long-term effects of ETAS450mg daily on cognitive, emotional, and brain health in healthy adults aged 60 to 80 years who have mild to moderate subjective cognitive complaints. This study uses a double-blind, randomized, placebo-controlled design to evaluate changes in cognitive function, mood, inflammation, metabolism, and body measurements over a 12-week period. Participants are randomly assigned to one of two groups: one receiving ETAS450mg capsules daily and the other receiving matched placebo capsules for 12 weeks. Outcome measures are taken before and after the intervention and include assessments of overall cognitive performance, executive function, language and memory, depression, anxiety, sleep quality, gastrointestinal symptoms, blood pressure, body measurements, and brain structure and function using MRI techniques. Additionally, a subset of participants will collect stool samples at home to analyze gut microbiome diversity and composition at baseline and after 12 weeks. Throughout the study, participants will undergo various tests and questionnaires to monitor cognitive, emotional, and physical health, including the Montreal Cognitive Assessment, fMRI, magnetic resonance spectroscopy, sleep quality indices, and more. Researchers will also track anthropometric data and blood pressure. The study aims to understand how chronic ETAS450mg supplementation influences these measures in older adults over the 12-week intervention period.

CONDITIONS

Brief Title

ETASCAN Project: ETAS Project 2

Who Can Participate

Age: 60Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged between 60 and 80 years old
  • Normal vision and hearing
  • Body mass index between 18.5 and 30
  • Mild to moderate subjective cognitive complaints
Not Eligible

You will not qualify if you...

  • Smoking
  • Food allergies
  • Following restrictive or unbalanced diets, including vegetarian or vegan diets and weight-reducing diets
  • Diagnosed psychiatric or neurologic conditions such as schizophrenia, depression, dementia, or eating disorders
  • Diagnosed cardiometabolic diseases including type II diabetes, cardiovascular disease, hypertension, thrombosis-related disorders, or thyroid disease
  • Current use of anticoagulants, antiplatelet medication, antidepressants, or proton-pump inhibitors
  • Current consumption of prebiotic or probiotic supplements
  • Continuous antibiotic use for more than 3 days within 1 month before enrollment
  • Continuous use of weight-loss drugs for more than 1 month before screening
  • Significant gastrointestinal conditions affecting absorption, including inflammatory bowel disease, total colectomy, bariatric surgery, irritable bowel disease, end-stage renal disease, active cancer, or cancer treatment within the last 3 years
  • History of claustrophobia
  • Having a pacemaker or artificial heart valve
  • Having active implants such as cochlear, ocular, or penile implants
  • Presence of metal fragments in the body
  • Having a drug infusion pump installed
  • Having surgically implanted metal in the body, excluding dental fillings and crowns
  • History of epilepsy
  • Having stimulators for nerves, brain, or bone installed
  • Having an intrauterine contraceptive device (IUD)
  • Wearing transdermal patches containing metal
  • Wearing dental appliances such as fillings, crowns, retainers, bridges, or braces
  • Need to remove colored contact lenses, nail polish, or makeup for scanning
  • Use of hearing aids
  • Having body piercings that cannot be removed for scanning
  • Having tattoos or permanent makeup

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 12 weeks

Participants consume capsules containing either 1500mg ETAS® or placebo daily for 12 weeks to evaluate effects on cognitive, affective, and neural outcomes.

1 baseline visit and 1 follow-up visit

Trial Site Locations

Total: 1 location

1

University of Reading, School of Psychology and Clinical Languages

Reading, Berkshire, United Kingdom, RG6 6ES

Actively Recruiting

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Research Team

P

Piril Hepsomali, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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