Back to resultsEffect of Coffeeberry on Mood, Motivation and Cognitive Performance
Primary Purpose
Fatigue, Mental, Alertness, Mood
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cherry-flavored still beverage
Placebo cherry-flavored still beverage
Sponsored by
About this trial
This is an interventional basic science trial for Fatigue, Mental focused on measuring alertness, mental fatigue, coffeeberry, coffee fruit
Eligibility Criteria
Inclusion Criteria:
- Are older than 17 and under 50 years of age
- Self-report of good health
Exclusion Criteria:
- Using any prescription medication including birth control
- Report hypersensitivity to caffeine
- Have visual impairment that cannot be corrected with glasses or contact lenses
- Report any food allergies
- Self-reported excessive leisure time physical activity (> 7 strenuous bouts per week)
- the presence of current gastrointestinal, sleep, or psychiatric disorder,
- Report pregnancy/lactation, illegal drug use, smoker
- failure to demonstrate adequate minimal performance on lab, computer-based cognitive tasks.
- Participation in another clinical trial within past 30 days
Sites / Locations
- Exercise Psychology Laboratory University of Georgia
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Placebo Comparator
Active Comparator
Arm Label
Coffeeberry 100 mg beverage
Coffeeberry 300 mg beverage
Placebo beverage
Caffeine 75 mg beverage
Arm Description
Appearance-matched to the other beverages
Appearance-matched to the other beverages
Appearance-matched to the other beverages
Appearance-matched to the other beverages
Outcomes
Primary Outcome Measures
Cognition score
Objective Cognitive Demand Battery (CDB) using Computerised Mental Performance Assessment framework tasks (COMPASS) for word and picture presentation and recall, serial 3 and 7 subtraction, Rapid Visual Information Processing (RVIP).
Fatigue score
Subjective Visual Analog Scale (VAS) rating from 1-100 mm from not at all to extremely, during Cognitive Demand Battery (CDB) using Computerised Mental Performance Assessment framework tasks (COMPASS)
Alertness score
Subjective Bond-Lader Visual Analog Scale (VAS) rating from 1-100 mm representing the full range of each dimension from not at all to extremely, during Cognitive Demand Battery (CDB) Visual Analog Scale (VAS) rating from 1-100 mm during Cognitive Demand Battery(CDB) within Computerised Mental Performance Assessment framework tasks (COMPASS)
Calmness score
Subjective Bond-Lader Visual Analog Scale (VAS) rating from 1-100 representing the full range of each dimension from not at all to extremely, during Cognitive Demand Battery (CDB)during Cognitive Demand Battery (CDB) Visual Analog Scale (VAS) rating from 1-100 mm during Cognitive Demand Battery(CDB) within Computerised Mental Performance Assessment framework tasks (COMPASS)
Contentedness score
Subjective Bond-Lader Visual Analog Scale (VAS) rating from 1-100 mm representing the full range of each dimension from not at all to extremely, during Cognitive Demand Battery (CDB)during Cognitive Demand Battery (CDB) Visual Analog Scale (VAS) rating from 1-100 mm during Cognitive Demand Battery(CDB) within Computerised Mental Performance Assessment framework tasks (COMPASS)
Motivation score
Subjective Visual Analog Scale (VAS) rating from 1-100 mm from not at all to extremely, during Cognitive Demand Battery (CDB) within Computerised Mental Performance Assessment framework tasks (COMPASS)
Energy score
Subjective mental and physical state energy and fatigues scales (EFS-State Scale). Composite scores range from 0 to 300 mm, from feelings of no energy to strongest feelings of energy during Cognitive Demand Battery (CDB) using Computerised Mental Performance Assessment framework tasks (COMPASS)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04974606
Brief Title
Effect of Coffeeberry on Mood, Motivation and Cognitive Performance
Official Title
Effect of Coffeeberry on Mood, Motivation and Cognitive Performance
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
June 28, 2016 (Actual)
Primary Completion Date
December 16, 2016 (Actual)
Study Completion Date
December 16, 2016 (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 purpose is to test the short-term effects of the acute consumption of two novel beverages made from coffeeberries, the fruit of the coffee plant (Coffea arabica) benchmarked against caffeine on several aspects of cognitive performance.
Preliminary studies suggest that flavanols and chlorogenic acids can enhance cognitive performance. It is unknown if drinks formulated with flavanols and chlorogenic acids (without high sugar or caffeine) improve cognition or mood to a similar extent as caffeine. Coffeeberry beverage comparisons will be made to a flavored positive control beverage containing caffeine and a flavored placebo beverage.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue, Mental, Alertness, Mood, Motivation, Cognitive Performance
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
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Coffeeberry 100 mg beverage
Arm Type
Experimental
Arm Description
Appearance-matched to the other beverages
Arm Title
Coffeeberry 300 mg beverage
Arm Type
Experimental
Arm Description
Appearance-matched to the other beverages
Arm Title
Placebo beverage
Arm Type
Placebo Comparator
Arm Description
Appearance-matched to the other beverages
Arm Title
Caffeine 75 mg beverage
Arm Type
Active Comparator
Arm Description
Appearance-matched to the other beverages
Intervention Type
Dietary Supplement
Intervention Name(s)
Cherry-flavored still beverage
Intervention Description
10 oz bottle
Intervention Type
Other
Intervention Name(s)
Placebo cherry-flavored still beverage
Intervention Description
10 oz bottle
Primary Outcome Measure Information:
Title
Cognition score
Description
Objective Cognitive Demand Battery (CDB) using Computerised Mental Performance Assessment framework tasks (COMPASS) for word and picture presentation and recall, serial 3 and 7 subtraction, Rapid Visual Information Processing (RVIP).
Time Frame
Change from baseline to 60 and 120 min post-consumption. Higher test scores are better.
Title
Fatigue score
Description
Subjective Visual Analog Scale (VAS) rating from 1-100 mm from not at all to extremely, during Cognitive Demand Battery (CDB) using Computerised Mental Performance Assessment framework tasks (COMPASS)
Time Frame
Change from baseline to 60 and 120 min post-consumption. Lower fatigue score is better.
Title
Alertness score
Description
Subjective Bond-Lader Visual Analog Scale (VAS) rating from 1-100 mm representing the full range of each dimension from not at all to extremely, during Cognitive Demand Battery (CDB) Visual Analog Scale (VAS) rating from 1-100 mm during Cognitive Demand Battery(CDB) within Computerised Mental Performance Assessment framework tasks (COMPASS)
Time Frame
Change from baseline to 60 and 120 min post-consumption. Higher alertness score is better.
Title
Calmness score
Description
Subjective Bond-Lader Visual Analog Scale (VAS) rating from 1-100 representing the full range of each dimension from not at all to extremely, during Cognitive Demand Battery (CDB)during Cognitive Demand Battery (CDB) Visual Analog Scale (VAS) rating from 1-100 mm during Cognitive Demand Battery(CDB) within Computerised Mental Performance Assessment framework tasks (COMPASS)
Time Frame
Change from baseline to 60 and 120 min post-consumption. Higher calmness score is better.
Title
Contentedness score
Description
Subjective Bond-Lader Visual Analog Scale (VAS) rating from 1-100 mm representing the full range of each dimension from not at all to extremely, during Cognitive Demand Battery (CDB)during Cognitive Demand Battery (CDB) Visual Analog Scale (VAS) rating from 1-100 mm during Cognitive Demand Battery(CDB) within Computerised Mental Performance Assessment framework tasks (COMPASS)
Time Frame
Change from baseline to 60 and 120 min post-consumption. Higher contentedness score is better.
Title
Motivation score
Description
Subjective Visual Analog Scale (VAS) rating from 1-100 mm from not at all to extremely, during Cognitive Demand Battery (CDB) within Computerised Mental Performance Assessment framework tasks (COMPASS)
Time Frame
Change from baseline to 60 and 120 min post-consumption. Higher motivation score is better.
Title
Energy score
Description
Subjective mental and physical state energy and fatigues scales (EFS-State Scale). Composite scores range from 0 to 300 mm, from feelings of no energy to strongest feelings of energy during Cognitive Demand Battery (CDB) using Computerised Mental Performance Assessment framework tasks (COMPASS)
Time Frame
Change from baseline to 60 and 120 min post-consumption. Stronger feelings of mental and physical energy are better.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Are older than 17 and under 50 years of age
Self-report of good health
Exclusion Criteria:
Using any prescription medication including birth control
Report hypersensitivity to caffeine
Have visual impairment that cannot be corrected with glasses or contact lenses
Report any food allergies
Self-reported excessive leisure time physical activity (> 7 strenuous bouts per week)
the presence of current gastrointestinal, sleep, or psychiatric disorder,
Report pregnancy/lactation, illegal drug use, smoker
failure to demonstrate adequate minimal performance on lab, computer-based cognitive tasks.
Participation in another clinical trial within past 30 days
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick J O'Connor
Organizational Affiliation
University of Georgia, Athens
Official's Role
Principal Investigator
Facility Information:
Facility Name
Exercise Psychology Laboratory University of Georgia
City
Athens
State/Province
Georgia
ZIP/Postal Code
30601
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Coffeeberry on Mood, Motivation and Cognitive Performance
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