Effect of Coffeeberry on Mood, Motivation and Cognitive Performance

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Coffeeberry on Mood, Motivation and Cognitive Performance

Conditions
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Fatigue, Mental, Alertness, Mood, Motivation, Cognitive Performance

Intervention / Treatment
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* Dietary Supplement: Cherry-flavored still beverage
* Other: Placebo cherry-flavored still beverage


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Coffeeberry 100 mg beverage<br>Appearance-matched to the other beverages | Dietary Supplement: Cherry-flavored still beverage<br>* 10 oz bottle<br>|
| Experimental: Coffeeberry 300 mg beverage<br>Appearance-matched to the other beverages | Dietary Supplement: Cherry-flavored still beverage<br>* 10 oz bottle<br>|
| Placebo Comparator: Placebo beverage<br>Appearance-matched to the other beverages | Other: Placebo cherry-flavored still beverage<br>* 10 oz bottle<br>|
| Active Comparator: Caffeine 75 mg beverage<br>Appearance-matched to the other beverages | Dietary Supplement: Cherry-flavored still beverage<br>* 10 oz bottle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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alertness, mental fatigue, coffeeberry, coffee fruit