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The primary aim of this randomised, double-blind, placebo-controlled, cross-over study is to assess the short-term cognitive effects of two beverages containing 100 and 300 mg coffeeberry extract (obtained from the fruit of the coffee plant (Coffea arabica) compared to a placebo beverage. The trial will utilise the COMPASS cognitive assessment system and cognitive demand battery (CDB) and mood visual analogue scales (VAS) with assessments taking place at baseline, 60- and 120-minutes post treatment, on four separate testing days separated by 7 days. A treatment containing 75 mg caffeine will be used as a positive control to document participants' responsiveness to an established psychostimulant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0 mg coffeeberry beverage | Placebo Comparator | Appearance-matched to the other products |
|
| 100 mg coffeeberry beverage | Experimental | Appearance-matched to the other products |
|
| 300 mg coffeeberry beverage | Experimental | Appearance-matched to the other products |
|
| 75 mg caffeine beverage | Active Comparator | Appearance-matched to the other products |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Other | 10 oz (296 ml) cherry flavored still beverage |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mental fatigue Visual Analog Scale (VAS) score | 0-100 mm subjective rating scale, not at all to extremely, within Computerised Mental Performance Assessment framework tasks (COMPASS) | Change from baseline to 120 min post-coffeeberry beverage (100 and 300 mg) consumption during a Cognitive Demand Battery (CDB), compared to placebo beverages. Less mental fatigue is better. |
| Mental alertness Visual Analog Scale (VAS) score | 0-100 mm subjective rating scale, not at all to extremely, within Computerised Mental Performance Assessment framework tasks (COMPASS) | Change from baseline to 120 min post-coffeeberry beverage (100 and 300 mg) consumption during a Cognitive Demand Battery (CDB), compared to placebo beverages. More mental alertness is better. |
| Measure | Description | Time Frame |
|---|---|---|
| Mental fatigue Visual Analog Scale (VAS) score | 0-100 mm subjective rating scale, not at all to extremely, within Computerised Mental Performance Assessment framework tasks (COMPASS). Less mental fatigue is better. | Change from baseline to 60 min post-coffeeberry beverage (100 and 300 mg) consumption, during a Cognitive Demand Battery (CDB), compared to placebo and caffeine beverages |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippa Jackson, PhD | Northumbria University Newcastle, UK | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brain, Performance and Nutrition Research Centre Northumbria University | Newcastle upon Tyne | NE1 8ST | United Kingdom |
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| ID | Term |
|---|---|
| D005222 | Mental Fatigue |
| ID | Term |
|---|---|
| D005221 | Fatigue |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
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| ID | Term |
|---|---|
| D002110 | Caffeine |
| ID | Term |
|---|---|
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011688 | Purinones |
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| Coffeeberry |
| Dietary Supplement |
10 oz (296 ml) cherry flavored still beverage |
|
| Caffeine | Dietary Supplement | 10 oz (296 ml) cherry flavored still beverage |
|
| Mental Alertness Visual Analog Scale (VAS) score | 0-100 mm subjective rating scale, not at all to extremely, from within Computerised Mental Performance Assessment framework tasks (COMPASS) | Change from baseline to 60 min post-coffeeberry beverage (100 and 300 mg) consumption, during a Cognitive Demand Battery (CDB), compared to placebo and caffeine beverages. More mental alertness is better. |
| Motivation Visual Analog Scale (VAS) score | 0-100 mm subjective rating scale from none to strongest feelings, within Computerised Mental Performance Assessment framework tasks (COMPASS) | Change from baseline to 60 and 120 min post-coffeeberry beverage (100 and 300 mg) consumption, during a Cognitive Demand Battery (CDB), compared to placebo and caffeine beverages. More motivation is better. |
| Fatigue (Mental State Energy and Fatigue Scales, (EFS)) score | Subjective feelings of mental energy and mental fatigue. Intensity rating scale from none to strongest, yields composite score ranging from 0-300, included within Computerised Mental Performance Assessment framework tasks (COMPASS) | Change from baseline to 60 and 120 min post-coffeeberry beverage (100 and 300 mg) consumption, following CBD, compared to placebo and caffeine beverages. Less fatigue is better. |
| Fatigue (Physical State Energy and Fatigue Scales, (EFS)) score | Subjective feelings of physical energy and physical fatigue. Intensity rating scale from none to strongest, yields composite score ranging from 0-300, included within Computerised Mental Performance Assessment framework tasks (COMPASS) | Change from baseline to 60 and 120 min post-coffeeberry beverage (100 and 300 mg) consumption, following CBD, compared to placebo and caffeine beverages. Less fatigue is better. |
| Alertness (Bond Lader Visual Analog Scale (VAS)) score | 0-100 mm subjective rating scale of intensity of feelings within Computerised Mental Performance Assessment framework tasks (COMPASS) | Change from baseline to 60 and 120 min post-coffeeberry beverage (100 and 300 mg) consumption, following CBD, compared to placebo and caffeine beverages. More alertness is better. |
| Calmness (Bond Lader Visual Analog Scale (VAS)) score | 0-100 mm subjective rating scale of intensity of feelings within Computerised Mental Performance Assessment framework tasks (COMPASS) | Change from baseline to 60 and 120 min post-coffeeberry beverage (100 and 300 mg) consumption, following CBD, compared to placebo and caffeine beverages. More calmness is better. |
| Contentedness (Bond Lader Visual Analog Scale (VAS)) score | 0-100 mm subjective rating scale of intensity of feelings within Computerised Mental Performance Assessment framework tasks (COMPASS) | Change from baseline to 60 and 120 min post-coffeeberry beverage (100 and 300 mg) consumption, following CBD, compared to placebo and caffeine beverages. More contentedness is better. |
| Change in cognitive function measures (Serial subtraction tasks, rapid visual information processing) scores | Objective tests within Computerised Mental Performance Assessment framework tasks (COMPASS) | Change from baseline to 60 and 120 min post-coffeeberry beverage (100 and 300 mg) consumption, compared to placebo and caffeine beverages. Higher scores are better. |
| Episodic memory tasks (delayed word recall, delayed word recognition, delayed picture recognition) score | Objective tests within Computerised Mental Performance Assessment framework tasks (COMPASS) | Comparison of recollection between coffeeberry beverage (100 and 300 mg), placebo and caffeine beverages to stimuli presented at baseline versus 120 min post-consumption. More recall is better. |
| D001519 | Behavior |
| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |