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Acute, randomized, placebo controlled, double blind, 4 arm crossover study to determine the effect of different combinations of plant based extracts on cognitive function and cerebral blood flow.
The objectives of this study are to assess the effects of oral consumption of three differing combinations of plant based extracts, on cognitive function and cerebral blood flow (using Near infrared Spectroscopy) in comparison to placebo. The primary outcome will be change in cognitive function and mental fatigue during extended performance of the Cognitive Demand Battery (CDB) at 1, 3 and 6 hours post- consumption.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cherry flavoured beverage 1 | Placebo Comparator | 10floz cherry flavoured test article | |
| Cherry flavoured beverage 2 | Experimental | 10floz of cherry flavoured test article with fruit, vegetable and herbal extracts |
|
| Cherry flavoured beverage 3 | Experimental | 10floz of cherry flavoured test article with fruit, vegetable and herbal extracts |
|
| Cherry flavoured beverage 4 | Experimental | 10floz of cherry flavoured test article with fruit, vegetable and herbal extracts |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beverage containing plant based extracts | Other | Intervention involves single exposure, oral consumption of test article following baseline measurements |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in cognitive function and fatigue during extended performance of the Cognitive Demand Battery (CDB) at 1, 3 and 6 hours post consumption Change in long term declarative memory at 1, 3 and 6 hours post-intervention. | 1-6 hours post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in executive function at 1, 3 and 6 hours post intervention. | 1-6 hours post intervention | |
| Change in cerebral blood flow parameters (oxygenated and deoxygenated haemoglobin levels and their sum) in the frontal cortex during task performance commencing at 1, 3 and 6 hours post-intervention. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David Kennedy, PhD | Contact | david.kennedy@northumbria.ac.uk | ||
| Philippa Jackson | Contact | philippa.jackson@northumbria.ac.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northumbria University | Newcastle upon Tyne | NE1 8ST | United Kingdom |
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| 1-6 hours post intervention |
| Change in episodic memory, as measured by immediate word recall, at 1, 3 and 6 hours post intervention. | 1-6 hours post intervention |
| Change in mood ratings, at 1,3 and 6 hours post intervention. | 1-6 hours post intervention |