Mood Clinical Trial
Official title:
Effect of Coffeeberry on Mood, Motivation and Cognitive Performance
Verified date | July 2021 |
Source | PepsiCo Global R&D |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | December 16, 2016 |
Est. primary completion date | December 16, 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 17 Years to 50 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Exercise Psychology Laboratory University of Georgia | Athens | Georgia |
Lead Sponsor | Collaborator |
---|---|
PepsiCo Global R&D |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | Change from baseline to 60 and 120 min post-consumption. Higher test scores are better. | |
Primary | 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) | Change from baseline to 60 and 120 min post-consumption. Lower fatigue score is better. | |
Primary | 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) | Change from baseline to 60 and 120 min post-consumption. Higher alertness score is better. | |
Primary | 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) | Change from baseline to 60 and 120 min post-consumption. Higher calmness score is better. | |
Primary | 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) | Change from baseline to 60 and 120 min post-consumption. Higher contentedness score is better. | |
Primary | 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) | Change from baseline to 60 and 120 min post-consumption. Higher motivation score is better. | |
Primary | 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) | Change from baseline to 60 and 120 min post-consumption. Stronger feelings of mental and physical energy are better. |
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