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OpenTrials
Completed

NCT Number: NCT07400614

Evaluating the Impact of Energy Drink Formulas on Alertness for an Extended Period

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

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Key information

Conditions

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northumbria U

Newcastle, Tyne, NE1 7RU, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

All beverages are flavor and color matched

Other

Caffeine with varying amounts of taurine and B vitamins

Flavored carbonated beverage, color-matched

Other

Base with 0 mg caffeine, taurine, vitamins

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    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.

  2. 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

    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)

  3. 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

    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.

  4. 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 )

    Cognitive function - attention measured as reaction time (in milliseconds), with a lower score indicating better performance using the Computerised Mental Performance Assessment System (COMPASS)

  5. 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 )

    Cognitive function - attention measured as a percentage, with a higher score indicating better performance using the Computerised Mental Performance Assessment System (COMPASS)

  6. 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 )

    Cognitive function - attention measured as reaction time (in milliseconds), with a lower score indicating better performance using the Computerised Mental Performance Assessment System (COMPASS)

  7. 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 )

    Cognitive function - attention measured as number of errors, with a lower score indicating better performance using the Computerised Mental Performance Assessment System (COMPASS)

  8. 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 )

    Cognitive function - attention measured as a percentage, with a higher score indicating better performance using the Computerised Mental Performance Assessment System (COMPASS)

  9. 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 )

    Cognitive function - attention measured as reaction time (in milliseconds), with a lower score indicating better performance using the Computerised Mental Performance Assessment System (COMPASS)

  10. 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 )

    Cognitive function - attention measured as a percentage, with a higher score indicating better performance using the Computerised Mental Performance Assessment System (COMPASS)

  11. 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 )

    Cognitive function - attention measured as reaction time (in milliseconds), with a lower score indicating better performance using the Computerised Mental Performance Assessment System (COMPASS)

  12. 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 )

    Cognitive function - attention measured as number of errors, with a lower score indicating better performance using the Computerised Mental Performance Assessment System (COMPASS)

Sponsors and collaborators

Lead sponsor

PepsiCo Global R&D

Industry

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 10, 2026
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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