Change in Cognitive Function and Fatigue During Extended Performance of the Cognitive Demand Battery (CDB) at 1, 3 and 6 Hours Post Consumption Clinical Trial
— CEOPTBOfficial title:
The Effects of Different Combinations of Plant Based Extracts on Cognitive Function and Cerebral Blood Flow in Humans
| NCT number | NCT02202629 |
| Other study ID # | PEP-1406 |
| Secondary ID | |
| Status | Not yet recruiting |
| Phase | N/A |
| First received | July 24, 2014 |
| Last updated | July 28, 2014 |
| Start date | July 2014 |
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.
| Status | Not yet recruiting |
| Enrollment | 32 |
| Est. completion date | |
| Est. primary completion date | December 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 49 Years |
| Eligibility |
Inclusion Criteria: - Are over 18 or under 49 years of age - Self-report of good health - Are not excluded on the basis of the following exclusion criteria - English is first language (some of the cognitive tests have only been validated in native English speakers) Exclusion Criteria: - Are below 18 or above 49 years of age - Are a smoker - Have food allergies or sensitivities to any of the ingredients contained in the investigational product or any other foodstuff - Currently take medication except the contraceptive pill - Have habitually used dietary supplements within the last month (defined as more than 3 consecutive days or 4 days in total) - Have sleep disturbances and/or are taking sleep aid medication - Have a Body Mass Index (BMI) outside of the range 18-35 kg/m2 - Have high blood pressure (systolic over 139 mm Hg or diastolic over 89 mm Hg) - Have a history of neurological, vascular or psychiatric illness including epilepsy or seizures (excluding depressive illness and anxiety) - Have a current diagnosis of anxiety or depression - Are pregnant, trying to get pregnant or breast feeding - Have a recent history of (within 12 months of screening visit) or strong potential for alcohol or substance abuse. Alcohol abuse is defined as more than 60g (men) / 40g (women) pure alcohol per day (7 / 5.5 units) - Are (or are seeking to become) pregnant or are lactating - Have learning difficulties, dyslexia or colour blindness - Have visual impairment that cannot be corrected with glasses or contact lenses - Have frequent migraines that require medication (more than or equal to 1 per month) - Have disorders of the blood - Have a heart disorder or a history of vascular illness - Have a respiratory disorder that requires regular medication (Note: participants with asthma who only take their medication occasionally/as required are eligible for this study) - Have type I or type II diabetes - Have a history of renal or hepatic disease, or other severe diseases of the gastrointestinal tract (e.g. iron accumulation, iron utilization disorders, hypercalcaemia, hypercalciuria), that are likely to interfere with metabolism/absorption/secretion of the product under investigation - Have any health condition that would prevent fulfillment of the study requirements - Are currently or have in the past 4 weeks participated in other clinical or nutrition intervention studies - Do not have a bank account (required for payment) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Northumbria University | Newcastle upon Tyne |
| Lead Sponsor | Collaborator |
|---|---|
| PepsiCo Global R&D |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No | |
| Secondary | Change in executive function at 1, 3 and 6 hours post intervention. | 1-6 hours post intervention | No | |
| Secondary | 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. | 1-6 hours post intervention | No | |
| Secondary | Change in episodic memory, as measured by immediate word recall, at 1, 3 and 6 hours post intervention. | 1-6 hours post intervention | No | |
| Secondary | Change in mood ratings, at 1,3 and 6 hours post intervention. | 1-6 hours post intervention | No |