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| Name | Class |
|---|---|
| Amino Up Chemicals Co., Ltd. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active 1: ETAS® (300mg) | Experimental | Subjects will consume 300mg ETAS®/day (capsule). |
|
| Active 1: ETAS® (1500mg) | Active Comparator | Subjects will consume 1500mg ETAS®/day (capsule). |
|
| Placebo: Matched placebo | Placebo Comparator | Subjects will consume a matched placebo capsule. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active 1 ETAS® | Dietary Supplement | 300 mg ETAS® |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Montreal Cognitive Assessment (MoCA) score | Composite measure of global cognitive function | From baseline (pre intervention) to week 12 (post intervention) |
| Inflammatory biomarker levels | IFN-γ, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, IL-13, TNF-α, CRP levels from plasma | From baseline (pre intervention) to week 12 (post intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Behaviour Rating Inventory of Executive Function Score | A validated questionnaire that measures inhibition, self-monitoring, planning, task monitoring, emotional control, working memory and organisation of materials. | From baseline (pre intervention) to week 12 (post intervention) |
| Cognitive Failures Questionnaire Score |
| Measure | Description | Time Frame |
|---|---|---|
| Telephone Interview for Cognitive Status-40 | A questionnaire that assesses cognitive status. It will be used to screen participants. Only individuals who score between 6 and 20 (depicting mild to moderate subjective cognitive complaints) will be included in the study. | Baseline (pre intervention) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Reading, School of Psychology and Clinical Languages | Reading | Berkshire | RG6 6ES | United Kingdom |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D020774 | Pick Disease of the Brain |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| Active 2 ETAS® |
| Dietary Supplement |
1500mg ETAS® |
|
| Placebo | Dietary Supplement | Matched placebo capsule |
|
A validated questionnaire that measures episodes of absent-mindedness, including slow performance on focused attention tasks. |
| From baseline (pre intervention) to week 12 (post intervention) |
| Geriatric Depression Scale scores | A validated self-report measure of depression that includes 15-items. | From baseline (pre intervention) to week 12 (post intervention) |
| Geriatric Anxiety Inventory scores | A validated self-report measure of anxiety that includes 20-items. | From baseline (pre intervention) to week 12 (post intervention) |
| Pittsburgh Sleep Quality Index Scores | A validated self-report measure of sleep quality. | From baseline (pre intervention) to week 12 (post intervention) |
| WHOQOL-BREF score | A validated measure of quality of life | 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) |
| 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) |
| D001523 | Mental Disorders |
| D057180 | Frontotemporal Dementia |
| D057174 | Frontotemporal Lobar Degeneration |
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |