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Plant Based Extracts and Cognition (CEOPTB)

Primary Purpose

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.

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Beverage containing plant based extracts
Sponsored by
PepsiCo Global R&D
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Change in Cognitive Function and Fatigue During Extended Performance of the Cognitive Demand Battery (CDB) at 1, 3 and 6 Hours Post Consumption

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Northumbria University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Cherry flavoured beverage 1

Cherry flavoured beverage 2

Cherry flavoured beverage 3

Cherry flavoured beverage 4

Arm Description

10floz cherry flavoured test article

10floz of cherry flavoured test article with fruit, vegetable and herbal extracts

10floz of cherry flavoured test article with fruit, vegetable and herbal extracts

10floz of cherry flavoured test article with fruit, vegetable and herbal extracts

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in executive function at 1, 3 and 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.
Change in episodic memory, as measured by immediate word recall, at 1, 3 and 6 hours post intervention.
Change in mood ratings, at 1,3 and 6 hours post intervention.

Full Information

First Posted
July 24, 2014
Last Updated
July 28, 2014
Sponsor
PepsiCo Global R&D
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1. Study Identification

Unique Protocol Identification Number
NCT02202629
Brief Title
Plant Based Extracts and Cognition
Acronym
CEOPTB
Official Title
The Effects of Different Combinations of Plant Based Extracts on Cognitive Function and Cerebral Blood Flow in Humans
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PepsiCo Global R&D

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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.

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cherry flavoured beverage 1
Arm Type
Placebo Comparator
Arm Description
10floz cherry flavoured test article
Arm Title
Cherry flavoured beverage 2
Arm Type
Experimental
Arm Description
10floz of cherry flavoured test article with fruit, vegetable and herbal extracts
Arm Title
Cherry flavoured beverage 3
Arm Type
Experimental
Arm Description
10floz of cherry flavoured test article with fruit, vegetable and herbal extracts
Arm Title
Cherry flavoured beverage 4
Arm Type
Experimental
Arm Description
10floz of cherry flavoured test article with fruit, vegetable and herbal extracts
Intervention Type
Other
Intervention Name(s)
Beverage containing plant based extracts
Intervention Description
Intervention involves single exposure, oral consumption of test article following baseline measurements
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Change in executive function at 1, 3 and 6 hours post intervention.
Time Frame
1-6 hours post intervention
Title
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
Title
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
Title
Change in mood ratings, at 1,3 and 6 hours post intervention.
Time Frame
1-6 hours post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Kennedy, PhD
Email
david.kennedy@northumbria.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Philippa Jackson
Email
philippa.jackson@northumbria.ac.uk
Facility Information:
Facility Name
Northumbria University
City
Newcastle upon Tyne
ZIP/Postal Code
NE1 8ST
Country
United Kingdom

12. IPD Sharing Statement

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Plant Based Extracts and Cognition

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