The Impact of Chronic Consumption of ETAS® for 12 Weeks on Cognitive, Affective, and Inflammatory Outcomes: A Randomised Parallel Group Placebo-controlled Feasibility Study
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Reading
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Montreal Cognitive Assessment (MoCA) score
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 60 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •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
Outcomes
Primary Outcomes
Montreal Cognitive Assessment (MoCA) score
Time Frame: From baseline (pre intervention) to week 12 (post intervention)
Composite measure of global cognitive function
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
- Behaviour Rating Inventory of Executive Function Score(From baseline (pre intervention) to week 12 (post intervention))
- Cognitive Failures Questionnaire Score(From baseline (pre intervention) to week 12 (post intervention))
- Geriatric Depression Scale scores(From baseline (pre intervention) to week 12 (post intervention))
- Geriatric Anxiety Inventory scores(From baseline (pre intervention) to week 12 (post intervention))
- Pittsburgh Sleep Quality Index Scores(From baseline (pre intervention) to week 12 (post intervention))
- WHOQOL-BREF score(From baseline (pre intervention) to week 12 (post intervention))
- Gastrointestinal Symptom Rating Scale Scores(From baseline (pre intervention) to week 12 (post intervention))
- EPIC Norfolk Food Frequency Questionnaire (FFQ)(From baseline (pre intervention) to week 12 (post intervention))
- Blood Pressure(From baseline (pre intervention) to week 12 (post intervention))
- Hip and waist circumference(From baseline (pre intervention) to week 12 (post intervention))
- Body Mass Index(From baseline (pre intervention) to week 12 (post intervention))
Investigators
Piril Hepsomali
Principle Investigator
University of Reading