Effect of Coffeeberry on Mood, Motivation and Cognitive Performance

July 13, 2021 updated by: PepsiCo Global R&D

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Athens, Georgia, United States, 30601
        • Exercise Psychology Laboratory University of Georgia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognition score
Time Frame: Change from baseline to 60 and 120 min post-consumption. Higher test scores are better.
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
Time Frame: Change from baseline to 60 and 120 min post-consumption. Lower fatigue score is better.
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
Time Frame: Change from baseline to 60 and 120 min post-consumption. Higher alertness score is better.
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
Time Frame: Change from baseline to 60 and 120 min post-consumption. Higher calmness score is better.
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
Time Frame: Change from baseline to 60 and 120 min post-consumption. Higher contentedness score is better.
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
Time Frame: Change from baseline to 60 and 120 min post-consumption. Higher motivation score is better.
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
Time Frame: Change from baseline to 60 and 120 min post-consumption. Stronger feelings of mental and physical energy are better.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PepsiCo Global R&D

Investigators

  • Principal Investigator: Patrick J O'Connor, University of Georgia, Athens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 28, 2016

Primary Completion (Actual)

December 16, 2016

Study Completion (Actual)

December 16, 2016

Study Registration Dates

First Submitted

July 9, 2021

First Submitted That Met QC Criteria

July 13, 2021

First Posted (Actual)

July 23, 2021

Study Record Updates

Last Update Posted (Actual)

July 23, 2021

Last Update Submitted That Met QC Criteria

July 13, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEP-1605

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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