NCT04974606

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 28, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2016

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

July 9, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 23, 2021

Completed
Last Updated

July 23, 2021

Status Verified

July 1, 2021

Enrollment Period

6 months

First QC Date

July 9, 2021

Last Update Submit

July 13, 2021

Conditions

Fatigue, MentalAlertnessMoodMotivationCognitive Performance

Keywords

alertnessmental fatiguecoffeeberrycoffee fruit

Outcome Measures

Primary Outcomes (7)

  • 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.

Study Arms (4)

Coffeeberry 100 mg beverage

EXPERIMENTAL

Appearance-matched to the other beverages

Dietary Supplement: Cherry-flavored still beverage

Coffeeberry 300 mg beverage

EXPERIMENTAL

Appearance-matched to the other beverages

Dietary Supplement: Cherry-flavored still beverage

Placebo beverage

PLACEBO COMPARATOR

Appearance-matched to the other beverages

Other: Placebo cherry-flavored still beverage

Caffeine 75 mg beverage

ACTIVE COMPARATOR

Appearance-matched to the other beverages

Dietary Supplement: Cherry-flavored still beverage

Interventions

Cherry-flavored still beverageDIETARY_SUPPLEMENT

10 oz bottle

Caffeine 75 mg beverageCoffeeberry 100 mg beverageCoffeeberry 300 mg beverage
Placebo cherry-flavored still beverageOTHER

10 oz bottle

Placebo beverage

Eligibility Criteria

Age17 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Are older than 17 and under 50 years of age
  • Self-report of good health

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exercise Psychology Laboratory University of Georgia

Athens, Georgia, 30601, United States

Location

MeSH Terms

Conditions

Mental Fatigue

Condition Hierarchy (Ancestors)

FatigueSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Study Officials

  • Patrick J O'Connor

    University of Georgia, Athens

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2021

First Posted

July 23, 2021

Study Start

June 28, 2016

Primary Completion

December 16, 2016

Study Completion

December 16, 2016

Last Updated

July 23, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)