Affect (Mental Function), Cognition, fMRI, Magnetic Resonance Spectroscopy, MRI, Sleep
Conditions
Keywords
grey matter, brain structure, brain function, neurochemistry, executive function, language, ETAS®, depression, anxiety, sleep, gut microbiome
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.
Interventions
DIETARY_SUPPLEMENTETAS®
1500mg ETAS®
DIETARY_SUPPLEMENTPlacebo
Matched placebo capsule
Sponsors
University of Reading
Amino Up Chemicals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 80 Years
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Montreal Cognitive Assessment (MoCA) score | From baseline (pre intervention) to week 12 (post intervention) | Composite measure of global cognitive function |
| fMRI | From baseline (pre intervention) to week 12 (post intervention) | Functional brain activity will be analysed during cognitive tasks. |
| MRS | 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
| Measure | Time frame | Description |
|---|---|---|
| Pittsburgh Sleep Quality Index Scores | From baseline (pre intervention) to week 12 (post intervention) | A validated self-report measure of sleep quality. |
| Immediate Word Recall from the Rey Auditory Verbal Learning Task | From baseline (pre intervention) to week 12 (post intervention) | Participants will be presented with a sequential list of 15 words, at a rate of 1 word per second. The participant will then have 60s to say out loud as many of these words as possible, with the resulting score recorded as a percentage of accuracy. |
| Delayed Word Recall from the Rey Auditory Verbal Learning Task | From baseline (pre intervention) to week 12 (post intervention) | After a period of time subject are asked to recall as many words as possible from list A |
| Gastrointestinal Symptom Rating Scale Scores | From baseline (pre intervention) to week 12 (post intervention) | A validated self-report measure of gastrointestinal symptoms that includes 15-items (combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation) |
| Brain structure | From baseline (pre intervention) to week 12 (post intervention) | Grey and white matter volume analysis of the brain will be conducted. |
| Patient Healthcare Questionnaire 8 (PHQ-8) | From baseline (pre intervention) to week 12 (post intervention) | A validated self-report measure of depressive symptoms that includes 8-items |
| Generalised anxiety disorder 7 item scale (GAD-7) | From baseline (pre intervention) to week 12 (post intervention) | A validated self-report measure of anxiety symptoms that includes 7-items |
| EPIC Norfolk Food Frequency Questionnaire (FFQ) | From baseline (pre intervention) to week 12 (post intervention) | The FFQ is a validated tool for gauging the average habitual dietary intake of micro and macronutrients of an individual in the UK. Data will be processed using the FETA software. |
| Blood Pressure | From baseline (pre intervention) to week 12 (post intervention) | Systolic and diastolic blood pressure (in mmHg) will be measured. |
| Hip and waist circumference | From baseline (pre intervention) to week 12 (post intervention) | Hip and waist circumference (in cm) will be measured. |
| Body mass index | From baseline (pre intervention) to week 12 (post intervention) | Weight (in kg) and height (in m) will be combined to report Body Mass Index in kg/m\^2. |
Countries
United Kingdom
Contacts
CONTACTPiril Hepsomali, PhD
Outcome results
None listed