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| Name | Class |
|---|---|
| Amino Up Chemicals Co., Ltd. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ETAS® (1500mg) | Experimental | Subjects will consume 1500mg ETAS®/day (capsule). |
|
| Matched placebo | Placebo Comparator | Subjects will consume a matched placebo capsule. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ETAS® | Dietary Supplement | 1500mg ETAS® |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Montreal Cognitive Assessment (MoCA) score | Composite measure of global cognitive function | From baseline (pre intervention) to week 12 (post intervention) |
| fMRI | Functional brain activity will be analysed during cognitive tasks. | From baseline (pre intervention) to week 12 (post intervention) |
| MRS | MRS will be used to assess neurochemistry of the medial temporal lobe and medial frontal cortex at rest. | From baseline (pre intervention) to week 12 (post intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Pittsburgh Sleep Quality Index Scores | A validated self-report measure of sleep quality. | From baseline (pre intervention) to week 12 (post intervention) |
| Immediate Word Recall from the Rey Auditory Verbal Learning Task |
| Measure | Description | Time Frame |
|---|---|---|
| Telephone Interview for Cognitive Status-40 | A questionnaire that assesses cognitive status. It will be used to screen participants. | Baseline (pre intervention) |
| Gut microbiome diversity | In a random subsample of participants, stool samples will be collected to measure gut microbiome diversity. Indices of alpha and beta diversity will be analysed (16s sequencing). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Piril Hepsomali, PhD | Contact | +44 118 378 5818 | p.hepsomali@reading.ac.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Reading, School of Psychology and Clinical Languages | Recruiting | Reading | Berkshire | RG6 6ES | United Kingdom |
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| ID | Term |
|---|---|
| D007802 | Language |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D003142 | Communication |
| D001519 | Behavior |
| D001526 | Behavioral Symptoms |
| D001523 | Mental Disorders |
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| Dietary Supplement |
Matched placebo capsule |
|
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.
| From baseline (pre intervention) to week 12 (post intervention) |
| Delayed Word Recall from the Rey Auditory Verbal Learning Task | After a period of time subject are asked to recall as many words as possible from list A | From baseline (pre intervention) to week 12 (post intervention) |
| Gastrointestinal Symptom Rating Scale Scores | 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) | From baseline (pre intervention) to week 12 (post intervention) |
| Brain structure | Grey and white matter volume analysis of the brain will be conducted. | From baseline (pre intervention) to week 12 (post intervention) |
| Patient Healthcare Questionnaire 8 (PHQ-8) | A validated self-report measure of depressive symptoms that includes 8-items | From baseline (pre intervention) to week 12 (post intervention) |
| Generalised anxiety disorder 7 item scale (GAD-7) | A validated self-report measure of anxiety symptoms that includes 7-items | From baseline (pre intervention) to week 12 (post intervention) |
| EPIC Norfolk Food Frequency Questionnaire (FFQ) | 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. | From baseline (pre intervention) to week 12 (post intervention) |
| Blood Pressure | Systolic and diastolic blood pressure (in mmHg) will be measured. | From baseline (pre intervention) to week 12 (post intervention) |
| Hip and waist circumference | Hip and waist circumference (in cm) will be measured. | From baseline (pre intervention) to week 12 (post intervention) |
| Body mass index | Weight (in kg) and height (in m) will be combined to report Body Mass Index in kg/m^2. | From baseline (pre intervention) to week 12 (post intervention) |
| From baseline (pre intervention) to week 12 (post intervention) |
| Gut microbiome composition | In a random subsample of participants, stool samples will be collected to measure gut microbiome composition (genus and species) (16s sequencing). | From baseline (pre intervention) to week 12 (post intervention) |