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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04974606
Other study ID # PEP-1605
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 28, 2016
Est. completion date December 16, 2016

Study information

Verified date July 2021
Source PepsiCo Global R&D
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Intervention

Dietary Supplement:
Cherry-flavored still beverage
10 oz bottle
Other:
Placebo cherry-flavored still beverage
10 oz bottle

Locations

Country Name City State
United States Exercise Psychology Laboratory University of Georgia Athens Georgia

Sponsors (1)

Lead Sponsor Collaborator
PepsiCo Global R&D

Country where clinical trial is conducted

United States, 

Outcome

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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