Mental FatigueNCT04975802
Effect of Coffeeberry on Mood and Cognitive Performance
A study testing Coffeeberry and Caffeine in people with Mental Fatigue and Alertness, run by PepsiCo Global R&D at 1 site in United Kingdom.
Trial summary
The primary aim of this randomised, double-blind, placebo-controlled, cross-over study is to assess the short-term cognitive effects of two beverages containing 100 and 300 mg coffeeberry extract (obtained from the fruit of the coffee plant (Coffea arabica) compared to a placebo beverage. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Fatigue, Alertness, Mood
- What is being tested?
- Coffeeberry and Caffeine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Jul 2021to 4 Feb 2022
- 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 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants are aged 18-49 years, inclusive
- Participants self-report that they are in good health
- Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial
- Willing to abstain from consumption of caffeine within 12 h of testing
- Willing to abstain from alcohol consumption and avoid vigorous physical activity for 24 h prior to all test visits
- Willing to refrain from 'over the counter' medications (e.g. pain medication) and stimulant medication for 12 hours, seasonal allergy/hay fever nasal antihistamine medications for 24 hours and oral antihistamines for 48 hours prior to all test visits
- Understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study Investigator.
Who cannot join
- Failure to meet any one of the inclusion criteria
- Current use of prescription medication, except for contraceptives
- Report hypersensitivity to caffeine
- Major trauma or major surgical event within 6 months of screening
- Extreme dietary habits, as judged by the Investigator (high fat, very high protein diets, intermittent fasting, etc.)
- Exposure to coffeeberry within 30 d prior to screening
Show all 28Show fewer
- History of cancer in the prior two years, except for non-melanoma skin cancer
- Have a visual impairment that cannot be corrected with glasses or contact lenses
- Food allergies/intolerances/sensitivities to any ingredients in the study products (including coffee or related foods/beverages/products)
- Self-report excessive leisure time physical activity (> 7 strenuous bouts per week)
- Have a current or chronic gastrointestinal, sleep, or psychiatric disorders
- Work night shifts or follow a variable work pattern that results in irregular sleep pattern
- Are pregnant, trying to get pregnant or lactating
- Smoke tobacco, vape nicotine or use nicotine replacement products
- Use illegal/recreational drugs
- Unable to demonstrate adequate minimal performance on lab, computer-based cognitive tasks
- Have participated in another clinical trial within past 30 days and/or participation in another PepsiCo trial in the past 6 months
- Have high blood pressure (systolic over 139 mm Hg or diastolic over 89 mm Hg)
- Have a Body Mass Index (BMI) outside of the range 18.5-35 kg/m2
- Have learning and/or behavioural disorders such as dyslexia or ADHD
- Excessive caffeine intake (>500 mg per day)
- Have taken dietary supplements e.g. Vitamins, omega 3 fish oils etc. in the last 4 weeks (Note: participation is possible following a 4 week supplement washout prior to participating and for the duration of the study on the proviso that the supplements they are taking are out of choice and not medically prescribed or advised)
- Have any health condition that would prevent fulfilment of the study requirements (this includes non-diagnosed conditions for which no medication may be taken)
- Has been diagnosed with/ undergoing treatment for alcohol or drug abuse in the last 12 months
- Have been diagnosed with/ undergoing treatment for a psychiatric disorder in the last 12 months
- Suffers from frequent migraines that require medication (more than or equal to 1 per month)
- Any known active infections
- Does not have a bank account (required for payment)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Brain, Performance and Nutrition Research Centre Northumbria University
Newcastle upon Tyne, NE1 8ST
About this study
The primary aim of this randomised, double-blind, placebo-controlled, cross-over study is to assess the short-term cognitive effects of two beverages containing 100 and 300 mg coffeeberry extract (obtained from the fruit of the coffee plant (Coffea arabica) compared to a placebo beverage. The trial will utilise the COMPASS cognitive assessment system and cognitive demand battery (CDB) and mood visual analogue scales (VAS) with assessments taking place at baseline, 60- and 120-minutes post treatment, on four separate testing days separated by 7 days. A treatment containing 75 mg caffeine will be used as a positive control to document participants' responsiveness to an established psychostimulant.
- Conditions
- Mental Fatigue, Alertness, Mood, Cognition
- Being tested
- Placebo, Coffeeberry, Caffeine
- 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.
PlaceboOther
10 oz (296 ml) cherry flavored still beverage
CoffeeberryDietary supplement
10 oz (296 ml) cherry flavored still beverage
CaffeineDietary supplement
10 oz (296 ml) cherry flavored still beverage
| Study group | Role | What they receive |
|---|---|---|
| 0 mg coffeeberry beverage | Placebo comparator | Appearance-matched to the other products Receives: Other: Placebo |
| 100 mg coffeeberry beverage | Experimental | Appearance-matched to the other products Receives: Dietary Supplement: Coffeeberry |
| 300 mg coffeeberry beverage | Experimental | Appearance-matched to the other products Receives: Dietary Supplement: Coffeeberry |
| 75 mg caffeine beverage | Active comparator | Appearance-matched to the other products Receives: Dietary Supplement: Caffeine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental fatigue Visual Analog Scale (VAS) score
0-100 mm subjective rating scale, not at all to extremely, within Computerised Mental Performance Assessment framework tasks (COMPASS)
Measured: Change from baseline to 120 min post-coffeeberry beverage (100 and 300 mg) consumption during a Cognitive Demand Battery (CDB), compared to placebo beverages. Less mental fatigue is better.
Mental alertness Visual Analog Scale (VAS) score
0-100 mm subjective rating scale, not at all to extremely, within Computerised Mental Performance Assessment framework tasks (COMPASS)
Measured: Change from baseline to 120 min post-coffeeberry beverage (100 and 300 mg) consumption during a Cognitive Demand Battery (CDB), compared to placebo beverages. More mental alertness is better.
Secondary outcomes (10)
Mental fatigue Visual Analog Scale (VAS) score
0-100 mm subjective rating scale, not at all to extremely, within Computerised Mental Performance Assessment framework tasks (COMPASS). Less mental fatigue is better.
Measured: Change from baseline to 60 min post-coffeeberry beverage (100 and 300 mg) consumption, during a Cognitive Demand Battery (CDB), compared to placebo and caffeine beverages
Mental Alertness Visual Analog Scale (VAS) score
0-100 mm subjective rating scale, not at all to extremely, from within Computerised Mental Performance Assessment framework tasks (COMPASS)
Measured: Change from baseline to 60 min post-coffeeberry beverage (100 and 300 mg) consumption, during a Cognitive Demand Battery (CDB), compared to placebo and caffeine beverages. More mental alertness is better.
Motivation Visual Analog Scale (VAS) score
0-100 mm subjective rating scale from none to strongest feelings, within Computerised Mental Performance Assessment framework tasks (COMPASS)
Measured: Change from baseline to 60 and 120 min post-coffeeberry beverage (100 and 300 mg) consumption, during a Cognitive Demand Battery (CDB), compared to placebo and caffeine beverages. More motivation is better.
Fatigue (Mental State Energy and Fatigue Scales, (EFS)) score
Subjective feelings of mental energy and mental fatigue. Intensity rating scale from none to strongest, yields composite score ranging from 0-300, included within Computerised Mental Performance Assessment framework tasks (COMPASS)
Measured: Change from baseline to 60 and 120 min post-coffeeberry beverage (100 and 300 mg) consumption, following CBD, compared to placebo and caffeine beverages. Less fatigue is better.
Fatigue (Physical State Energy and Fatigue Scales, (EFS)) score
Subjective feelings of physical energy and physical fatigue. Intensity rating scale from none to strongest, yields composite score ranging from 0-300, included within Computerised Mental Performance Assessment framework tasks (COMPASS)
Measured: Change from baseline to 60 and 120 min post-coffeeberry beverage (100 and 300 mg) consumption, following CBD, compared to placebo and caffeine beverages. Less fatigue is better.
Alertness (Bond Lader Visual Analog Scale (VAS)) score
0-100 mm subjective rating scale of intensity of feelings within Computerised Mental Performance Assessment framework tasks (COMPASS)
Measured: Change from baseline to 60 and 120 min post-coffeeberry beverage (100 and 300 mg) consumption, following CBD, compared to placebo and caffeine beverages. More alertness is better.
Calmness (Bond Lader Visual Analog Scale (VAS)) score
0-100 mm subjective rating scale of intensity of feelings within Computerised Mental Performance Assessment framework tasks (COMPASS)
Measured: Change from baseline to 60 and 120 min post-coffeeberry beverage (100 and 300 mg) consumption, following CBD, compared to placebo and caffeine beverages. More calmness is better.
Contentedness (Bond Lader Visual Analog Scale (VAS)) score
0-100 mm subjective rating scale of intensity of feelings within Computerised Mental Performance Assessment framework tasks (COMPASS)
Measured: Change from baseline to 60 and 120 min post-coffeeberry beverage (100 and 300 mg) consumption, following CBD, compared to placebo and caffeine beverages. More contentedness is better.
Change in cognitive function measures (Serial subtraction tasks, rapid visual information processing) scores
Objective tests within Computerised Mental Performance Assessment framework tasks (COMPASS)
Measured: Change from baseline to 60 and 120 min post-coffeeberry beverage (100 and 300 mg) consumption, compared to placebo and caffeine beverages. Higher scores are better.
Episodic memory tasks (delayed word recall, delayed word recognition, delayed picture recognition) score
Objective tests within Computerised Mental Performance Assessment framework tasks (COMPASS)
Measured: Comparison of recollection between coffeeberry beverage (100 and 300 mg), placebo and caffeine beverages to stimuli presented at baseline versus 120 min post-consumption. More recall is 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 start5 Jul 2021
- Primary completion4 Feb 2022
- Study completion4 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental FatigueStudies 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
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- PepsiCo Global R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philippa Jackson, PhD, Principal investigator, Northumbria University Newcastle, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04975802
- Sponsor's protocol ID
- PEP-2005
- Status last verified
- Mar 2022
- First submitted
- 14 Jul 2021
- Last updated
- 24 Mar 2022
- 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 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Coffeeberry on Mood and Cognitive Performance
- ClinicalTrials.gov ID
- NCT04975802
- Acronym / sponsor ID
- PEP-2005
- Conditions
- Mental Fatigue, Alertness, Mood, Cognition
- Keywords
- alertness, mental fatigue, coffeeberry, coffee fruit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Study start
- 5 Jul 2021 (actual)
- Primary completion
- 4 Feb 2022 (actual)
- Study completion
- 4 Feb 2022 (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 aim of this randomised, double-blind, placebo-controlled, cross-over study is to assess the short-term cognitive effects of two beverages containing 100 and 300 mg coffeeberry extract (obtained from the fruit of the coffee plant (Coffea arabica) compared to a placebo beverage. The trial will utilise the COMPASS cognitive assessment system and cognitive demand battery (CDB) and mood visual analogue scales (VAS) with assessments taking place at baseline, 60- and 120-minutes post treatment, on four separate testing days separated by 7 days. A treatment containing 75 mg caffeine will be used as a positive control to document participants' responsiveness to an established psychostimulant.
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 |
|---|---|---|
| 0 mg coffeeberry beverage | Placebo comparator | Other: PlaceboAppearance-matched to the other products |
| 100 mg coffeeberry beverage | Experimental | Dietary Supplement: CoffeeberryAppearance-matched to the other products |
| 300 mg coffeeberry beverage | Experimental | Dietary Supplement: CoffeeberryAppearance-matched to the other products |
| 75 mg caffeine beverage | Active comparator | Dietary Supplement: CaffeineAppearance-matched to the other products |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Participants are aged 18-49 years, inclusive
- Participants self-report that they are in good health
- Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial
- Willing to abstain from consumption of caffeine within 12 h of testing
- Willing to abstain from alcohol consumption and avoid vigorous physical activity for 24 h prior to all test visits
Key exclusion criteria (28 listed)
- Failure to meet any one of the inclusion criteria
- Current use of prescription medication, except for contraceptives
- Report hypersensitivity to caffeine
- Major trauma or major surgical event within 6 months of screening
- Extreme dietary habits, as judged by the Investigator (high fat, very high protein diets, intermittent fasting, etc.)
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 |
|---|---|---|
| Placebo10 oz (296 ml) cherry flavored still beverage | Other | 0 mg coffeeberry beverage |
| Coffeeberry10 oz (296 ml) cherry flavored still beverage | Dietary supplement | 100 mg coffeeberry beverage, 300 mg coffeeberry beverage |
| Caffeine10 oz (296 ml) cherry flavored still beverage | Dietary supplement | 75 mg caffeine beverage |
Primary outcome
Mental fatigue Visual Analog Scale (VAS) score
Time frame: Change from baseline to 120 min post-coffeeberry beverage (100 and 300 mg) consumption during a Cognitive Demand Battery (CDB), compared to placebo beverages. Less mental fatigue is better.
0-100 mm subjective rating scale, not at all to extremely, within Computerised Mental Performance Assessment framework tasks (COMPASS)
Mental alertness Visual Analog Scale (VAS) score
Time frame: Change from baseline to 120 min post-coffeeberry beverage (100 and 300 mg) consumption during a Cognitive Demand Battery (CDB), compared to placebo beverages. More mental alertness is better.
0-100 mm subjective rating scale, not at all to extremely, within Computerised Mental Performance Assessment framework tasks (COMPASS)
10 secondary outcomes
Mental fatigue Visual Analog Scale (VAS) score
Time frame: Change from baseline to 60 min post-coffeeberry beverage (100 and 300 mg) consumption, during a Cognitive Demand Battery (CDB), compared to placebo and caffeine beverages
Mental Alertness Visual Analog Scale (VAS) score
Time frame: Change from baseline to 60 min post-coffeeberry beverage (100 and 300 mg) consumption, during a Cognitive Demand Battery (CDB), compared to placebo and caffeine beverages. More mental alertness is better.
Motivation Visual Analog Scale (VAS) score
Time frame: Change from baseline to 60 and 120 min post-coffeeberry beverage (100 and 300 mg) consumption, during a Cognitive Demand Battery (CDB), compared to placebo and caffeine beverages. More motivation is better.
Fatigue (Mental State Energy and Fatigue Scales, (EFS)) score
Time frame: Change from baseline to 60 and 120 min post-coffeeberry beverage (100 and 300 mg) consumption, following CBD, compared to placebo and caffeine beverages. Less fatigue is better.
Fatigue (Physical State Energy and Fatigue Scales, (EFS)) score
Time frame: Change from baseline to 60 and 120 min post-coffeeberry beverage (100 and 300 mg) consumption, following CBD, compared to placebo and caffeine beverages. Less fatigue is better.
Alertness (Bond Lader Visual Analog Scale (VAS)) score
Time frame: Change from baseline to 60 and 120 min post-coffeeberry beverage (100 and 300 mg) consumption, following CBD, compared to placebo and caffeine beverages. More alertness is better.
Calmness (Bond Lader Visual Analog Scale (VAS)) score
Time frame: Change from baseline to 60 and 120 min post-coffeeberry beverage (100 and 300 mg) consumption, following CBD, compared to placebo and caffeine beverages. More calmness is better.
Contentedness (Bond Lader Visual Analog Scale (VAS)) score
Time frame: Change from baseline to 60 and 120 min post-coffeeberry beverage (100 and 300 mg) consumption, following CBD, compared to placebo and caffeine beverages. More contentedness is better.
Change in cognitive function measures (Serial subtraction tasks, rapid visual information processing) scores
Time frame: Change from baseline to 60 and 120 min post-coffeeberry beverage (100 and 300 mg) consumption, compared to placebo and caffeine beverages. Higher scores are better.
Episodic memory tasks (delayed word recall, delayed word recognition, delayed picture recognition) score
Time frame: Comparison of recollection between coffeeberry beverage (100 and 300 mg), placebo and caffeine beverages to stimuli presented at baseline versus 120 min post-consumption. More recall is better.
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 24 Mar 2022.
- Individual participant dataSharing planned: No
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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.
Philippa Jackson, PhD principal investigator
Northumbria University Newcastle, UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coffeeberry and Caffeine in people with Mental Fatigue and Alertness, run by PepsiCo Global R&D at 1 site in United Kingdom.
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 7 inclusion and 28 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 24 Mar 2022. 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 Kingdom. 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?
Mental fatigue Visual Analog Scale (VAS) score (time frame: Change from baseline to 120 min post-coffeeberry beverage (100 and 300 mg) consumption during a Cognitive Demand Battery (CDB), compared to placebo beverages. Less mental fatigue is better.). The study lists 2 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 24 Mar 2022.