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Plant Based Extracts and Cognition (CEOPTB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02202629
Recruitment Status : Unknown
Verified July 2014 by PepsiCo Global R&D.
Recruitment status was:  Not yet recruiting
First Posted : July 29, 2014
Last Update Posted : July 29, 2014
Sponsor:
Information provided by (Responsible Party):
PepsiCo Global R&D

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
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. Other: Beverage containing plant based extracts Not Applicable

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: The Effects of Different Combinations of Plant Based Extracts on Cognitive Function and Cerebral Blood Flow in Humans
Study Start Date : July 2014
Estimated Primary Completion Date : December 2014
Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Cherry flavoured beverage 1
10floz cherry flavoured test article
Experimental: Cherry flavoured beverage 2
10floz of cherry flavoured test article with fruit, vegetable and herbal extracts
 Other: Beverage containing plant based extracts
Intervention involves single exposure, oral consumption of test article following baseline measurements
Experimental: Cherry flavoured beverage 3
10floz of cherry flavoured test article with fruit, vegetable and herbal extracts
 Other: Beverage containing plant based extracts
Intervention involves single exposure, oral consumption of test article following baseline measurements
Experimental: Cherry flavoured beverage 4
10floz of cherry flavoured test article with fruit, vegetable and herbal extracts
 Other: Beverage containing plant based extracts
Intervention involves single exposure, oral consumption of test article following baseline measurements


Outcome Measures
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Primary Outcome Measures :
  1. 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. [ Time Frame: 1-6 hours post intervention ]

Secondary Outcome Measures :
  1. Change in executive function at 1, 3 and 6 hours post intervention. [ Time Frame: 1-6 hours post intervention ]
  2. 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. [ Time Frame: 1-6 hours post intervention ]
  3. Change in episodic memory, as measured by immediate word recall, at 1, 3 and 6 hours post intervention. [ Time Frame: 1-6 hours post intervention ]
  4. Change in mood ratings, at 1,3 and 6 hours post intervention. [ Time Frame: 1-6 hours post intervention ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02202629


Contacts
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Contact: David Kennedy, PhD david.kennedy@northumbria.ac.uk
Contact: Philippa Jackson philippa.jackson@northumbria.ac.uk

Locations
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United Kingdom
Northumbria University
Newcastle upon Tyne, United Kingdom, NE1 8ST
Sponsors and Collaborators
PepsiCo Global R&D
More Information
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Responsible Party: PepsiCo Global R&D
ClinicalTrials.gov Identifier: NCT02202629    
Other Study ID Numbers: PEP-1406
First Posted: July 29, 2014    Key Record Dates
Last Update Posted: July 29, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Fatigue