12-week ETAS® supplement for thinking, mood, sleep, and brain health in older adults
The Impact of Chronic Consumption of ETAS® for 12 Weeks on Cognitive, Affective, and Neural Outcomes: A Randomised Parallel Group Placebo-controlled Study
NA · University of Reading · NCT07550140
This 12-week test will see if taking 1500 mg ETAS® daily helps thinking, mood, sleep, and brain scan measures in healthy adults aged 60–80 with mild cognitive complaints.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 60 Years to 80 Years |
| Sex | All |
| Sponsor | University of Reading (other) |
| Locations | 1 site (Reading, Berkshire) |
| Trial ID | NCT07550140 on ClinicalTrials.gov |
What this trial studies
This is a double-blind, randomized, placebo-controlled parallel trial in 60 healthy older adults (60–80 years) with mild to moderate subjective cognitive complaints. Participants will take capsules containing 1500 mg ETAS® or placebo daily for 12 weeks, with cognitive, affective, sleep, metabolic, inflammatory, anthropometric, and blood pressure measures collected before and after supplementation. Brain structure, function, and chemistry will be measured with MRI/fMRI at both time points, and a randomly selected subset of 30 participants (15 per group) will provide stool samples for microbiome analysis at two time points. Individuals taking excluded medications or with diagnosed psychiatric, neurologic, cardiometabolic, or thyroid disorders are not eligible.
Who should consider this trial
Good fit: Healthy adults aged 60–80 with mild to moderate subjective cognitive complaints, normal vision and hearing, BMI between 18.5 and 30, and not taking excluded medications are the intended participants.
Not a fit: People with diagnosed psychiatric or neurologic disorders (including dementia or major depression), cardiometabolic disease, thyroid disease, current smokers, or those on excluded medications are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, ETAS® could modestly improve memory and executive function, reduce mood and sleep symptoms, and produce measurable changes in brain scans for older adults with mild cognitive complaints.
How similar studies have performed: Prior human data on ETAS® are limited and preliminary, with some early biomarker and safety findings but little large-scale clinical evidence for cognitive benefit.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Reading, Berkshire
- University of Reading, School of Psychology and Clinical Languages — Reading, Berkshire, United Kingdom (RECRUITING)
Study contacts
- Study coordinator: Piril Hepsomali, PhD
- Email: p.hepsomali@reading.ac.uk
- Phone: +44 118 378 5818
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cognition, Affect, Sleep, MRI, fMRI, Magnetic Resonance Spectroscopy, grey matter, brain structure