AlertnessNCT07400614
Evaluating the Impact of Energy Drink Formulas on Alertness for an Extended Period
A study testing All beverages are flavor and color matched and Flavored carbonated beverage, color-matched in people with Alertness, run by PepsiCo Global R&D at 1 site in United Kingdom.
Trial summary
The primary purpose of the research is to evaluate in healthy adults the time course effects of energy drink formulas containing 120 mg caffeine with varying levels of taurine and b vitamins on subjective alertness in the presence of cognitive load assessed hourly up to 5 hours post dose Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Alertness
- What is being tested?
- All beverages are flavor and color matched and Flavored carbonated beverage, color-matched
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Jan 2026to 30 Jun 2026
- 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 for 12 h prior to 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/hayfever nasal antihistamine medications for 24 hours and oral antihistamines for 48 hours prior to all test visits
Show all 9Show fewer
- Regular caffeine consumer (at least one caffeinated beverage per day, not less than 35 mg)
- Are fluent in English (equivalent to IELTS Level 6)
- Understand 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
- Fail to meet any one of the inclusion criteria
- Currently use of prescription medication, including contraceptives
- Report hypersensitivity to caffeine
- Have experienced major trauma or major surgical event within 6 months of screening
- Have extreme dietary habits, as judged by the Investigator (high fat, very high protein diets, intermittent fasting, etc.)
- Have a history of cancer in the prior two years, except for non-melanoma skin cancer
Show all 27Show fewer
- Have a visual impairment that cannot be corrected with glasses or contact lenses
- Have 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 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
- Are unable to demonstrate adequate minimal performance on lab, computer-based cognitive tasks
- 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 (unless waist to hip ratio is less than or equal to 0.85 (female) or 0.90 (male))
- Have been diagnosed with a neurological condition, or assessed as having a learning/behavioural or neurodevelopmental difference (e.g. dyslexia, autism, ADHD)
- Consume excessive caffeine intake (>400 mg per day)
- Have taken any 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)
- Have 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
- Suffer from frequent migraines that require medication (more than or equal to 1 per month)
- Have any known active infections
- Do not have a bank account (required for payment)
- Have participated in another clinical trial within past 30 days and/or participation in another PepsiCo trial in the past 6 months
Trial locations and contacts
1 site in 1 country.
About this study
The primary purpose of the research is to evaluate in healthy adults the time course effects of energy drink formulas containing 120 mg caffeine with varying levels of taurine and b vitamins on subjective alertness in the presence of cognitive load assessed hourly up to 5 hours post dose
- Conditions
- Alertness
- Being tested
- All beverages are flavor and color matched, Flavored carbonated beverage, color-matched
- Keywords
- alertness, energy, caffeine, beverage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
All beverages are flavor and color matchedOther
Caffeine with varying amounts of taurine and B vitamins
Flavored carbonated beverage, color-matchedOther
Base with 0 mg caffeine, taurine, vitamins
| Study group | Role | What they receive |
|---|---|---|
| Placebo beverage | Placebo comparator | Base carbonated beverage with no caffeine, taurine, or vitamins Receives: Other: Flavored carbonated beverage, color-matched |
| Caffeine 120 mg beverage 1 | Experimental | Carbonated beverage with varying levels of taurine and B vitamins Receives: Other: All beverages are flavor and color matched |
| Caffeine 120 mg beverage 2 | Experimental | Carbonated beverage with varying levels of taurine and B vitamins Receives: Other: All beverages are flavor and color matched |
| Caffeine 120 mg beverage 3 | Experimental | Carbonated beverage with varying levels of taurine and B vitamins Receives: Other: All beverages are flavor and color matched |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caffeine Research Visual Analog Scale (VAS) subjective alertness factor adapted from Rogers et al.
Subjective 'alert' and 'tired' ratings combined to create a composite alertness factor. Alert ratings assessed by placing an 'x' on a line representing 0-100 to match their current state; tired ratings assessed by placing an 'x' on a line representing 0-100 to match their current state. Higher alert ratings represent a better outcome, higher tired ratings represent a worse outcome and are reversed to create the composite score, which is the average of the two scales and is scored 0-100 with higher scores representing a better outcome.
Measured: Change from baseline Time 0 to 240 minutes post-dose
Secondary outcomes (12)
Caffeine Research Visual Analog Scale (VAS) subjective alertness factor adapted from Rogers et al.
Subjective 'alert' and 'tired' ratings combined to create a composite alertness factor. Alert ratings assessed by placing an 'x' on a line representing 0-100 to match their current state; tired ratings assessed by placing an 'x' on a line representing 0-100 to match their current state. Higher alert ratings represent a better outcome, higher tired ratings represent a worse outcome and are reversed to create the composite score, which is the average of the two scales and is scored 0-100 with higher scores representing a better outcome.
Measured: Change from baseline Time 0 to 60, 120, 180, 240 & 300 minutes post-dose
Caffeine Research Visual Analog Scale (VAS) individual scales adapted from Rogers et al.
Subjective ratings assessed by placing an 'x' on a line representing 0-100 to match their current state (relaxed, alert, jittery, tired, tense, headache, overall mood, mental fatigue)
Measured: Change from baseline Time 0 to 60, 120, 180, 240 & 300 minutes post-dose
Caffeine Research VAS measures (Visual Analog Scale) subjective tension factor adapted from Rogers et al.
Subjective 'relaxed' and 'tense' ratings combined to create a composite tension factor. Relaxed ratings assessed by placing an 'x' on a line representing 0-100 to match their current state; tense ratings assessed by placing an 'x' on a line representing 0-100 to match their current state. Higher tense ratings represent a worse outcome, higher relaxed ratings represent a better outcome and are reversed to create the composite score, which is the average of the two scales and is scored 0-100 with higher scores representing a worse outcome.
Measured: Change from baseline Time 0 to 60, 120, 180, 240 & 300 minutes post-dose
Simple reaction time
Cognitive function - attention measured as reaction time (in milliseconds), with a lower score indicating better performance using the Computerised Mental Performance Assessment System (COMPASS)
Measured: Change from baseline Time 0 to 60, 120, 180, 240 & 300 minutes post-dose. Each test has duration ~21 minutes )
Digit vigilance accuracy
Cognitive function - attention measured as a percentage, with a higher score indicating better performance using the Computerised Mental Performance Assessment System (COMPASS)
Measured: Change from baseline Time 0 to 60, 120, 180, 240 & 300 minutes post-dose. Each test has duration ~21 minutes )
Digit vigilance reaction time
Cognitive function - attention measured as reaction time (in milliseconds), with a lower score indicating better performance using the Computerised Mental Performance Assessment System (COMPASS)
Measured: Change from baseline Time 0 to 60, 120, 180, 240 & 300 minutes post-dose. Each test has duration ~21 minutes )
Digit vigilance false alarms
Cognitive function - attention measured as number of errors, with a lower score indicating better performance using the Computerised Mental Performance Assessment System (COMPASS)
Measured: Change from baseline Time 0 to 60, 120, 180, 240 & 300 minutes post-dose. Each test has duration ~21 minutes )
Choice reaction accuracy (%)
Cognitive function - attention measured as a percentage, with a higher score indicating better performance using the Computerised Mental Performance Assessment System (COMPASS)
Measured: Change from baseline Time 0 to 60, 120, 180, 240 & 300 minutes post-dose. Each test has duration ~21 minutes )
Choice reaction accuracy (milliseconds)
Cognitive function - attention measured as reaction time (in milliseconds), with a lower score indicating better performance using the Computerised Mental Performance Assessment System (COMPASS)
Measured: Change from baseline Time 0 to 60, 120, 180, 240 & 300 minutes post-dose. Each test has duration ~21 minutes )
Rapid visual information processing accuracy
Cognitive function - attention measured as a percentage, with a higher score indicating better performance using the Computerised Mental Performance Assessment System (COMPASS)
Measured: Change from baseline Time 0 to 60, 120, 180, 240 & 300 minutes post-dose. Each test has duration ~21 minutes )
Rapid visual information processing reaction time
Cognitive function - attention measured as reaction time (in milliseconds), with a lower score indicating better performance using the Computerised Mental Performance Assessment System (COMPASS)
Measured: Change from baseline Time 0 to 60, 120, 180, 240 & 300 minutes post-dose. Each test has duration ~21 minutes )
Rapid visual information processing false alarms
Cognitive function - attention measured as number of errors, with a lower score indicating better performance using the Computerised Mental Performance Assessment System (COMPASS)
Measured: Change from baseline Time 0 to 60, 120, 180, 240 & 300 minutes post-dose. Each test has duration ~21 minutes )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start26 Jan 2026
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlertnessStudies 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- PepsiCo Global R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Crystal Haskell-Ramsay, PhD, Principal investigator, Northumbria U Newcastle, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07400614
- Sponsor's protocol ID
- PEP-2514
- Status last verified
- Jul 2026
- First submitted
- 3 Feb 2026
- Last updated
- 24 Jul 2026
- 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 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of Energy Drink Formulas on Alertness for an Extended Period
- ClinicalTrials.gov ID
- NCT07400614
- Acronym / sponsor ID
- PEP-2514
- Conditions
- Alertness
- Keywords
- alertness, energy, caffeine, beverage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Study start
- 26 Jan 2026 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 10 Feb 2026 (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 of the research is to evaluate in healthy adults the time course effects of energy drink formulas containing 120 mg caffeine with varying levels of taurine and b vitamins on subjective alertness in the presence of cognitive load assessed hourly up to 5 hours post dose
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 |
|---|---|---|
| Placebo beverage | Placebo comparator | Other: Flavored carbonated beverage, color-matchedBase carbonated beverage with no caffeine, taurine, or vitamins |
| Caffeine 120 mg beverage 1 | Experimental | Other: All beverages are flavor and color matchedCarbonated beverage with varying levels of taurine and B vitamins |
| Caffeine 120 mg beverage 2 | Experimental | Other: All beverages are flavor and color matchedCarbonated beverage with varying levels of taurine and B vitamins |
| Caffeine 120 mg beverage 3 | Experimental | Other: All beverages are flavor and color matchedCarbonated beverage with varying levels of taurine and B vitamins |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 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 for 12 h prior to testing
- Willing to abstain from alcohol consumption and avoid vigorous physical activity for 24 h prior to all test visits
Key exclusion criteria (27 listed)
- Fail to meet any one of the inclusion criteria
- Currently use of prescription medication, including contraceptives
- Report hypersensitivity to caffeine
- Have experienced major trauma or major surgical event within 6 months of screening
- Have 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 |
|---|---|---|
| All beverages are flavor and color matchedCaffeine with varying amounts of taurine and B vitamins | Other | Caffeine 120 mg beverage 1, Caffeine 120 mg beverage 2, Caffeine 120 mg beverage 3 |
| Flavored carbonated beverage, color-matchedBase with 0 mg caffeine, taurine, vitamins | Other | Placebo beverage |
Primary outcome
Caffeine Research Visual Analog Scale (VAS) subjective alertness factor adapted from Rogers et al.
Time frame: Change from baseline Time 0 to 240 minutes post-dose
Subjective 'alert' and 'tired' ratings combined to create a composite alertness factor. Alert ratings assessed by placing an 'x' on a line representing 0-100 to match their current state; tired ratings assessed by placing an 'x' on a line representing 0-100 to match their current state. Higher alert ratings represent a better outcome, higher tired ratings represent a worse outcome and are reversed to create the composite score, which is the average of the two scales and is scored 0-100 with higher scores representing a better outcome.
12 secondary outcomes
Caffeine Research Visual Analog Scale (VAS) subjective alertness factor adapted from Rogers et al.
Time frame: Change from baseline Time 0 to 60, 120, 180, 240 & 300 minutes post-dose
Caffeine Research Visual Analog Scale (VAS) individual scales adapted from Rogers et al.
Time frame: Change from baseline Time 0 to 60, 120, 180, 240 & 300 minutes post-dose
Caffeine Research VAS measures (Visual Analog Scale) subjective tension factor adapted from Rogers et al.
Time frame: Change from baseline Time 0 to 60, 120, 180, 240 & 300 minutes post-dose
Simple reaction time
Time frame: Change from baseline Time 0 to 60, 120, 180, 240 & 300 minutes post-dose. Each test has duration ~21 minutes )
Digit vigilance accuracy
Time frame: Change from baseline Time 0 to 60, 120, 180, 240 & 300 minutes post-dose. Each test has duration ~21 minutes )
Digit vigilance reaction time
Time frame: Change from baseline Time 0 to 60, 120, 180, 240 & 300 minutes post-dose. Each test has duration ~21 minutes )
Digit vigilance false alarms
Time frame: Change from baseline Time 0 to 60, 120, 180, 240 & 300 minutes post-dose. Each test has duration ~21 minutes )
Choice reaction accuracy (%)
Time frame: Change from baseline Time 0 to 60, 120, 180, 240 & 300 minutes post-dose. Each test has duration ~21 minutes )
Choice reaction accuracy (milliseconds)
Time frame: Change from baseline Time 0 to 60, 120, 180, 240 & 300 minutes post-dose. Each test has duration ~21 minutes )
Rapid visual information processing accuracy
Time frame: Change from baseline Time 0 to 60, 120, 180, 240 & 300 minutes post-dose. Each test has duration ~21 minutes )
Rapid visual information processing reaction time
Time frame: Change from baseline Time 0 to 60, 120, 180, 240 & 300 minutes post-dose. Each test has duration ~21 minutes )
Rapid visual information processing false alarms
Time frame: Change from baseline Time 0 to 60, 120, 180, 240 & 300 minutes post-dose. Each test has duration ~21 minutes )
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 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Alertness
Not yet recruiting
Fatigue in Long-Haul Operations
Alertness, Fatigue, Mood, and Performance, Calorie Restriction and Light Intervention
Active, not recruiting
Impact of Canadian Haskap Berry Powder on Hypertension and Acuity in Women's Health
Hypertension, Alertness
Enrolling by invitationEarly Phase 1
Effectiveness of Microdosed GLP-1 in Improving Health, Quality of Life, and Longevity Measures
Longevity, Quality of Life
Recruiting
Acoustic Stimulation During Restricted Sleep After Sleep Deprivation
Sleep Deprivation, Sleep Restriction
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.
Crystal Haskell-Ramsay, PhD principal investigator
Northumbria U 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 All beverages are flavor and color matched and Flavored carbonated beverage, color-matched in people with 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 9 inclusion and 27 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 Jul 2026. 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?
Caffeine Research Visual Analog Scale (VAS) subjective alertness factor adapted from Rogers et al. (time frame: Change from baseline Time 0 to 240 minutes post-dose). 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 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.