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Effect of Coffeeberry on Mood and Cognitive Performance

Primary Purpose

Mental Fatigue, Alertness, Mood

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Placebo
Coffeeberry
Caffeine
Sponsored by
PepsiCo Global R&D
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Mental Fatigue focused on measuring alertness, mental fatigue, coffeeberry, coffee fruit

Eligibility Criteria

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

Inclusion Criteria:

  • Participants are aged 18-49 years, inclusive
  • Participants self-report that they are in good health
  • Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial
  • Willing to abstain from consumption of caffeine within 12 h of testing
  • Willing to abstain from alcohol consumption and avoid vigorous physical activity for 24 h prior to all test visits
  • Willing to refrain from 'over the counter' medications (e.g. pain medication) and stimulant medication for 12 hours, seasonal allergy/hay fever nasal antihistamine medications for 24 hours and oral antihistamines for 48 hours prior to all test visits
  • Understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study Investigator.

Exclusion Criteria:

  • Failure to meet any one of the inclusion criteria
  • Current use of prescription medication, except for contraceptives
  • Report hypersensitivity to caffeine
  • Major trauma or major surgical event within 6 months of screening
  • Extreme dietary habits, as judged by the Investigator (high fat, very high protein diets, intermittent fasting, etc.)
  • Exposure to coffeeberry within 30 d prior to screening
  • History of cancer in the prior two years, except for non-melanoma skin cancer
  • Have a visual impairment that cannot be corrected with glasses or contact lenses
  • Food allergies/intolerances/sensitivities to any ingredients in the study products (including coffee or related foods/beverages/products)
  • Self-report excessive leisure time physical activity (> 7 strenuous bouts per week)
  • Have a current or chronic gastrointestinal, sleep, or psychiatric disorders
  • Work night shifts or follow a variable work pattern that results in irregular sleep pattern
  • Are pregnant, trying to get pregnant or lactating
  • Smoke tobacco, vape nicotine or use nicotine replacement products
  • Use illegal/recreational drugs
  • Unable to demonstrate adequate minimal performance on lab, computer-based cognitive tasks
  • Have participated in another clinical trial within past 30 days and/or participation in another PepsiCo trial in the past 6 months
  • Have high blood pressure (systolic over 139 mm Hg or diastolic over 89 mm Hg)
  • Have a Body Mass Index (BMI) outside of the range 18.5-35 kg/m2
  • Have learning and/or behavioural disorders such as dyslexia or ADHD
  • Excessive caffeine intake (>500 mg per day)
  • Have taken dietary supplements e.g. Vitamins, omega 3 fish oils etc. in the last 4 weeks (Note: participation is possible following a 4 week supplement washout prior to participating and for the duration of the study on the proviso that the supplements they are taking are out of choice and not medically prescribed or advised)
  • Have any health condition that would prevent fulfilment of the study requirements (this includes non-diagnosed conditions for which no medication may be taken)
  • Has been diagnosed with/ undergoing treatment for alcohol or drug abuse in the last 12 months
  • Have been diagnosed with/ undergoing treatment for a psychiatric disorder in the last 12 months
  • Suffers from frequent migraines that require medication (more than or equal to 1 per month)
  • Any known active infections
  • Does not have a bank account (required for payment)

Sites / Locations

  • Brain, Performance and Nutrition Research Centre Northumbria University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Active Comparator

Arm Label

0 mg coffeeberry beverage

100 mg coffeeberry beverage

300 mg coffeeberry beverage

75 mg caffeine beverage

Arm Description

Appearance-matched to the other products

Appearance-matched to the other products

Appearance-matched to the other products

Appearance-matched to the other products

Outcomes

Primary Outcome Measures

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)
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)

Secondary Outcome Measures

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.
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)
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)
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)
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)
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)
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)
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 in cognitive function measures (Serial subtraction tasks, rapid visual information processing) scores
Objective tests within Computerised Mental Performance Assessment framework tasks (COMPASS)
Episodic memory tasks (delayed word recall, delayed word recognition, delayed picture recognition) score
Objective tests within Computerised Mental Performance Assessment framework tasks (COMPASS)

Full Information

First Posted
July 14, 2021
Last Updated
March 23, 2022
Sponsor
PepsiCo Global R&D
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1. Study Identification

Unique Protocol Identification Number
NCT04975802
Brief Title
Effect of Coffeeberry on Mood and Cognitive Performance
Official Title
Effect of Coffeeberry on Mood and Cognitive Performance
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
July 5, 2021 (Actual)
Primary Completion Date
February 4, 2022 (Actual)
Study Completion Date
February 4, 2022 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Fatigue, Alertness, Mood, Cognition
Keywords
alertness, mental fatigue, coffeeberry, coffee fruit

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0 mg coffeeberry beverage
Arm Type
Placebo Comparator
Arm Description
Appearance-matched to the other products
Arm Title
100 mg coffeeberry beverage
Arm Type
Experimental
Arm Description
Appearance-matched to the other products
Arm Title
300 mg coffeeberry beverage
Arm Type
Experimental
Arm Description
Appearance-matched to the other products
Arm Title
75 mg caffeine beverage
Arm Type
Active Comparator
Arm Description
Appearance-matched to the other products
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
10 oz (296 ml) cherry flavored still beverage
Intervention Type
Dietary Supplement
Intervention Name(s)
Coffeeberry
Intervention Description
10 oz (296 ml) cherry flavored still beverage
Intervention Type
Dietary Supplement
Intervention Name(s)
Caffeine
Intervention Description
10 oz (296 ml) cherry flavored still beverage
Primary Outcome Measure Information:
Title
Mental fatigue Visual Analog Scale (VAS) score
Description
0-100 mm subjective rating scale, not at all to extremely, within Computerised Mental Performance Assessment framework tasks (COMPASS)
Time Frame
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.
Title
Mental alertness Visual Analog Scale (VAS) score
Description
0-100 mm subjective rating scale, not at all to extremely, within Computerised Mental Performance Assessment framework tasks (COMPASS)
Time Frame
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.
Secondary Outcome Measure Information:
Title
Mental fatigue Visual Analog Scale (VAS) score
Description
0-100 mm subjective rating scale, not at all to extremely, within Computerised Mental Performance Assessment framework tasks (COMPASS). Less mental fatigue is better.
Time Frame
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
Title
Mental Alertness Visual Analog Scale (VAS) score
Description
0-100 mm subjective rating scale, not at all to extremely, from within Computerised Mental Performance Assessment framework tasks (COMPASS)
Time Frame
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.
Title
Motivation Visual Analog Scale (VAS) score
Description
0-100 mm subjective rating scale from none to strongest feelings, within Computerised Mental Performance Assessment framework tasks (COMPASS)
Time Frame
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.
Title
Fatigue (Mental State Energy and Fatigue Scales, (EFS)) score
Description
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)
Time Frame
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.
Title
Fatigue (Physical State Energy and Fatigue Scales, (EFS)) score
Description
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)
Time Frame
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.
Title
Alertness (Bond Lader Visual Analog Scale (VAS)) score
Description
0-100 mm subjective rating scale of intensity of feelings within Computerised Mental Performance Assessment framework tasks (COMPASS)
Time Frame
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.
Title
Calmness (Bond Lader Visual Analog Scale (VAS)) score
Description
0-100 mm subjective rating scale of intensity of feelings within Computerised Mental Performance Assessment framework tasks (COMPASS)
Time Frame
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.
Title
Contentedness (Bond Lader Visual Analog Scale (VAS)) score
Description
0-100 mm subjective rating scale of intensity of feelings within Computerised Mental Performance Assessment framework tasks (COMPASS)
Time Frame
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.
Title
Change in cognitive function measures (Serial subtraction tasks, rapid visual information processing) scores
Description
Objective tests within Computerised Mental Performance Assessment framework tasks (COMPASS)
Time Frame
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.
Title
Episodic memory tasks (delayed word recall, delayed word recognition, delayed picture recognition) score
Description
Objective tests within Computerised Mental Performance Assessment framework tasks (COMPASS)
Time Frame
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.

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: Participants are aged 18-49 years, inclusive Participants self-report that they are in good health Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial Willing to abstain from consumption of caffeine within 12 h of testing Willing to abstain from alcohol consumption and avoid vigorous physical activity for 24 h prior to all test visits Willing to refrain from 'over the counter' medications (e.g. pain medication) and stimulant medication for 12 hours, seasonal allergy/hay fever nasal antihistamine medications for 24 hours and oral antihistamines for 48 hours prior to all test visits Understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study Investigator. Exclusion Criteria: Failure to meet any one of the inclusion criteria Current use of prescription medication, except for contraceptives Report hypersensitivity to caffeine Major trauma or major surgical event within 6 months of screening Extreme dietary habits, as judged by the Investigator (high fat, very high protein diets, intermittent fasting, etc.) Exposure to coffeeberry within 30 d prior to screening History of cancer in the prior two years, except for non-melanoma skin cancer Have a visual impairment that cannot be corrected with glasses or contact lenses Food allergies/intolerances/sensitivities to any ingredients in the study products (including coffee or related foods/beverages/products) Self-report excessive leisure time physical activity (> 7 strenuous bouts per week) Have a current or chronic gastrointestinal, sleep, or psychiatric disorders Work night shifts or follow a variable work pattern that results in irregular sleep pattern Are pregnant, trying to get pregnant or lactating Smoke tobacco, vape nicotine or use nicotine replacement products Use illegal/recreational drugs Unable to demonstrate adequate minimal performance on lab, computer-based cognitive tasks Have participated in another clinical trial within past 30 days and/or participation in another PepsiCo trial in the past 6 months Have high blood pressure (systolic over 139 mm Hg or diastolic over 89 mm Hg) Have a Body Mass Index (BMI) outside of the range 18.5-35 kg/m2 Have learning and/or behavioural disorders such as dyslexia or ADHD Excessive caffeine intake (>500 mg per day) Have taken dietary supplements e.g. Vitamins, omega 3 fish oils etc. in the last 4 weeks (Note: participation is possible following a 4 week supplement washout prior to participating and for the duration of the study on the proviso that the supplements they are taking are out of choice and not medically prescribed or advised) Have any health condition that would prevent fulfilment of the study requirements (this includes non-diagnosed conditions for which no medication may be taken) Has been diagnosed with/ undergoing treatment for alcohol or drug abuse in the last 12 months Have been diagnosed with/ undergoing treatment for a psychiatric disorder in the last 12 months Suffers from frequent migraines that require medication (more than or equal to 1 per month) Any known active infections Does not have a bank account (required for payment)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippa Jackson, PhD
Organizational Affiliation
Northumbria University Newcastle, UK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brain, Performance and Nutrition Research Centre Northumbria University
City
Newcastle upon Tyne
ZIP/Postal Code
NE1 8ST
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Coffeeberry on Mood and Cognitive Performance

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