The Impact of Chronic Consumption of ETAS® for 12 Weeks on Cognitive, Affective, and Neural Outcomes: A Randomised Parallel Group Placebo-controlled Study
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Reading
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Montreal Cognitive Assessment (MoCA) score
Overview
Brief Summary
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.
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
- •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
Arms & Interventions
ETAS® (1500mg)
Subjects will consume 1500mg ETAS®/day (capsule).
Intervention: ETAS® (Dietary Supplement)
Matched placebo
Subjects will consume a matched placebo capsule.
Intervention: Placebo (Dietary Supplement)
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
fMRI
Time Frame: From baseline (pre intervention) to week 12 (post intervention)
Functional brain activity will be analysed during cognitive tasks.
MRS
Time Frame: From baseline (pre intervention) to week 12 (post intervention)
MRS will be used to assess neurochemistry of the medial temporal lobe and medial frontal cortex at rest.
Secondary Outcomes
- Pittsburgh Sleep Quality Index Scores(From baseline (pre intervention) to week 12 (post intervention))
- Immediate Word Recall from the Rey Auditory Verbal Learning Task(From baseline (pre intervention) to week 12 (post intervention))
- Delayed Word Recall from the Rey Auditory Verbal Learning Task(From baseline (pre intervention) to week 12 (post intervention))
- Gastrointestinal Symptom Rating Scale Scores(From baseline (pre intervention) to week 12 (post intervention))
- Brain structure(From baseline (pre intervention) to week 12 (post intervention))
- Patient Healthcare Questionnaire 8 (PHQ-8)(From baseline (pre intervention) to week 12 (post intervention))
- Generalised anxiety disorder 7 item scale (GAD-7)(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