Fatigue, MentalNCT04974606
Effect of Coffeeberry on Mood, Motivation and Cognitive Performance
A study testing Cherry-flavored still beverage in people with Fatigue, Mental and Alertness, run by PepsiCo Global R&D at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 17 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Fatigue, Mental, Alertness, Mood
- What is being tested?
- Cherry-flavored still beverage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2016to 16 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Are older than 17 and under 50 years of age
- Self-report of good health
Who cannot join
- 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,
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Exercise Psychology Laboratory University of Georgia
Athens, Georgia, 30601
About this study
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.
- Conditions
- Fatigue, Mental, Alertness, Mood, Motivation, Cognitive Performance
- Being tested
- Cherry-flavored still beverage, Placebo cherry-flavored still beverage
- Keywords
- alertness, mental fatigue, coffeeberry, coffee fruit
- Medical subject headings
- Mental Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cherry-flavored still beverageDietary supplement
10 oz bottle
Placebo cherry-flavored still beverageOther
10 oz bottle
| Study group | Role | What they receive |
|---|---|---|
| Coffeeberry 100 mg beverage | Experimental | Appearance-matched to the other beverages Receives: Dietary Supplement: Cherry-flavored still beverage |
| Coffeeberry 300 mg beverage | Experimental | Appearance-matched to the other beverages Receives: Dietary Supplement: Cherry-flavored still beverage |
| Placebo beverage | Placebo comparator | Appearance-matched to the other beverages Receives: Other: Placebo cherry-flavored still beverage |
| Caffeine 75 mg beverage | Active comparator | Appearance-matched to the other beverages Receives: Dietary Supplement: Cherry-flavored still beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Change from baseline to 60 and 120 min post-consumption. Stronger feelings of mental and physical energy are better.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start28 Jun 2016
- Primary completion16 Dec 2016
- Study completion16 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatigue, MentalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- PepsiCo Global R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrick J O'Connor, Principal investigator, University of Georgia, Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04974606
- Sponsor's protocol ID
- PEP-1605
- Status last verified
- Jul 2021
- First submitted
- 9 Jul 2021
- Last updated
- 23 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Coffeeberry on Mood, Motivation and Cognitive Performance
- ClinicalTrials.gov ID
- NCT04974606
- Acronym / sponsor ID
- PEP-1605
- Conditions
- Fatigue, Mental, Alertness, Mood, Motivation, Cognitive Performance
- Keywords
- alertness, mental fatigue, coffeeberry, coffee fruit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Study start
- 28 Jun 2016 (actual)
- Primary completion
- 16 Dec 2016 (actual)
- Study completion
- 16 Dec 2016 (actual)
- First posted
- 23 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Coffeeberry 100 mg beverage | Experimental | Dietary Supplement: Cherry-flavored still beverageAppearance-matched to the other beverages |
| Coffeeberry 300 mg beverage | Experimental | Dietary Supplement: Cherry-flavored still beverageAppearance-matched to the other beverages |
| Placebo beverage | Placebo comparator | Other: Placebo cherry-flavored still beverageAppearance-matched to the other beverages |
| Caffeine 75 mg beverage | Active comparator | Dietary Supplement: Cherry-flavored still beverageAppearance-matched to the other beverages |
Who may qualify
- Ages
- 17 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Are older than 17 and under 50 years of age
- Self-report of good health
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cherry-flavored still beverage10 oz bottle | Dietary supplement | Caffeine 75 mg beverage, Coffeeberry 100 mg beverage, Coffeeberry 300 mg beverage |
| Placebo cherry-flavored still beverage10 oz bottle | Other | Placebo beverage |
Primary outcome
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).
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)
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)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
- Individual participant dataSharing planned: No
Related trials for Fatigue, Mental
Not yet recruiting
Mind Body Reprogramming Therapy for Adolescents With Chronic Fatigue
Chronic Fatigue
Not yet recruiting
COG+OT Telerehabilitation for Adults With Subjective Cognitive Complaints
Subjective Cognitive Complaints, Ehlers-Danlos Syndrome
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Not yet recruiting
A Clinical Trial to Evaluate the Effects of A Supplement on Symptoms of Menopause and Overall Well-being
Menopause, Menopausal Symptoms
Active, not recruiting
Long COVID Brain Fog: Cognitive Rehabilitation Trial
Long COVID, Brain Fog
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick J O'Connor principal investigator
University of Georgia, Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cherry-flavored still beverage in people with Fatigue, Mental and Alertness, run by PepsiCo Global R&D at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognition score (time frame: Change from baseline to 60 and 120 min post-consumption. Higher test scores are better.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2021.