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Recruiting NCT07550140

ETASCAN Project: ETAS Project 2

No phase Interventional Cognition Affect (Mental Function) Sleep MRI

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ETAS®, Placebo.
Who it may be relevant to
Registry conditions: Cognition, Affect (Mental Function), Sleep, MRI. Basic parameters: 60 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Impact of Chronic Consumption of ETAS® for 12 Weeks on Cognitive, Affective, and Neural Outcomes: A Randomised Parallel Group Placebo-controlled Study

Overview

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.

Detailed description

This 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. Sixty participants will be randomised to Intervention or Placebo groups where they will be consuming capsules containing 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 language/memory; affective measures of depression and anxiety symptomatology; and sleep; gastrointestinal symptomatology ; systolic and diastolic blood pressure, as well as height, weight, hip and waist circumference. Brain structure, function, and chemistry at both time points. Furthermore, random selection of participants (n=30, 15 in each group) will receive at home stool sample collection kits and microbiome diversity and compoisiton will be analysed at two time points.

Interventions

  • Dietary supplement ETAS®
    1500mg ETAS®
  • Dietary supplement Placebo
    Matched placebo capsule

Primary outcome measures

  • Montreal Cognitive Assessment (MoCA) score [Time frame: From baseline (pre intervention) to week 12 (post intervention)]
  • fMRI [Time frame: From baseline (pre intervention) to week 12 (post intervention)]
  • MRS [Time frame: From baseline (pre intervention) to week 12 (post intervention)]
Secondary outcome measures (11)
  • Pittsburgh Sleep Quality Index Scores [Time frame: From baseline (pre intervention) to week 12 (post intervention)]
  • Immediate Word Recall from the Rey Auditory Verbal Learning Task [Time frame: From baseline (pre intervention) to week 12 (post intervention)]
  • Delayed Word Recall from the Rey Auditory Verbal Learning Task [Time frame: 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)]
  • Brain structure [Time frame: From baseline (pre intervention) to week 12 (post intervention)]
  • Patient Healthcare Questionnaire 8 (PHQ-8) [Time frame: From baseline (pre intervention) to week 12 (post intervention)]
  • Generalised anxiety disorder 7 item scale (GAD-7) [Time frame: 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)]
  • Blood Pressure [Time frame: From baseline (pre intervention) to week 12 (post intervention)]
  • Hip and waist circumference [Time frame: From baseline (pre intervention) to week 12 (post intervention)]
  • Body mass index [Time frame: From baseline (pre intervention) to week 12 (post intervention)]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Basic science

Study locations

United Kingdom · 1 center
  • University of Reading, School of Psychology and Clinical Languages — Reading

Identifiers

NCT: NCT07550140 · 2025-229-PH

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗