Clinical trial NCT06790849: ETASCAI Pilot Project
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cognition
Affect (Mental Function)
Inflammation
Keywords: ETAS®
cognition
depression
anxiety
sleep
quality of life
inflammation
tau
Lead sponsor: University of Reading
Sponsor class: OTHER
Collaborators: name: Amino Up Chemicals Co., Ltd.
First posted: 2025-01-24
Enrollment: 45
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

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.

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 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

Primary outcomes:
measure: Montreal Cognitive Assessment (MoCA) score
timeFrame: From baseline (pre intervention) to week 12 (post intervention)
measure: Inflammatory biomarker levels
timeFrame: From baseline (pre intervention) to week 12 (post intervention)
Secondary outcomes:
measure: Behaviour Rating Inventory of Executive Function Score
timeFrame: From baseline (pre intervention) to week 12 (post intervention)
measure: Cognitive Failures Questionnaire Score
timeFrame: From baseline (pre intervention) to week 12 (post intervention)
measure: Geriatric Depression Scale scores
timeFrame: From baseline (pre intervention) to week 12 (post intervention)
measure: Geriatric Anxiety Inventory scores
timeFrame: From baseline (pre intervention) to week 12 (post intervention)
measure: Pittsburgh Sleep Quality Index Scores
timeFrame: From baseline (pre intervention) to week 12 (post intervention)
measure: WHOQOL-BREF score
timeFrame: From baseline (pre intervention) to week 12 (post intervention)
measure: Gastrointestinal Symptom Rating Scale Scores
timeFrame: From baseline (pre intervention) to week 12 (post intervention)
measure: EPIC Norfolk Food Frequency Questionnaire (FFQ)
timeFrame: From baseline (pre intervention) to week 12 (post intervention)
measure: Blood Pressure
timeFrame: From baseline (pre intervention) to week 12 (post intervention)
measure: Hip and waist circumference
timeFrame: From baseline (pre intervention) to week 12 (post intervention)
measure: Body Mass Index
timeFrame: From baseline (pre intervention) to week 12 (post intervention)
Other outcomes:
measure: Telephone Interview for Cognitive Status-40
timeFrame: Baseline (pre intervention)
Locations:
city: Reading
country: United Kingdom
facility: University of Reading, School of Psychology and Clinical Languages
state: Berkshire
Study officials:
References: