Effect of Coffeeberry on Mood, Motivation and Cognitive Performance

Sponsor
PepsiCo Global R&D (Industry)
Overall Status
Completed
CT.gov ID
NCT04974606
Collaborator
(none)
30
1
4
5.6
5.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Cherry-flavored still beverage
  • Other: Placebo cherry-flavored still beverage
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Effect of Coffeeberry on Mood, Motivation and Cognitive Performance
Actual Study Start Date :
Jun 28, 2016
Actual Primary Completion Date :
Dec 16, 2016
Actual Study Completion Date :
Dec 16, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Cognition score [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).

  2. Fatigue score [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)

  3. Alertness score [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)

  4. Calmness score [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)

  5. Contentedness score [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)

  6. Motivation score [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)

  7. Energy score [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
17 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Exercise Psychology Laboratory University of Georgia Athens Georgia United States 30601

Sponsors and Collaborators

  • PepsiCo Global R&D

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
PepsiCo Global R&D
ClinicalTrials.gov Identifier:
NCT04974606
Other Study ID Numbers:
  • PEP-1605
First Posted:
Jul 23, 2021
Last Update Posted:
Jul 23, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by PepsiCo Global R&D
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 23, 2021