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

NCT07400614 | Recruiting

• 1 other identifier: PEP-2514
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Alertness

Keywords

alertness; energy; caffeine; beverage

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from baseline Time 0 to 240 minutes post-dose

Secondary Outcomes (10)

• Caffeine Research VAS measures (Visual Analog Scale) subjective tension factor adapted from Rogers et al.

  Change from baseline Time 0 to 60, 120, 180, 240 & 300 minutes post-dose

• Simple reaction time

  Change from baseline Time 0 to 60, 120, 180, 240 & 300 minutes post-dose. Each test has duration ~21 minutes )

• Digit vigilance accuracy

  Change from baseline Time 0 to 60, 120, 180, 240 & 300 minutes post-dose. Each test has duration ~21 minutes )

• Digit vigilance reaction time

  Change from baseline Time 0 to 60, 120, 180, 240 & 300 minutes post-dose. Each test has duration ~21 minutes )

• Digit vigilance false alarms

  Change from baseline Time 0 to 60, 120, 180, 240 & 300 minutes post-dose. Each test has duration ~21 minutes )

Study Arms (4)

Placebo beverage

PLACEBO COMPARATOR

Base carbonated beverage with no caffeine, taurine, or vitamins

Other: Flavored carbonated beverage, color-matched

Caffeine 120 mg beverage 1

EXPERIMENTAL

Carbonated beverage with varying levels of taurine and B vitamins

Other: All beverages are flavor and color matched

Caffeine 120 mg beverage 2

EXPERIMENTAL

Carbonated beverage with varying levels of taurine and B vitamins

Other: All beverages are flavor and color matched

Caffeine 120 mg beverage 3

EXPERIMENTAL

Carbonated beverage with varying levels of taurine and B vitamins

Other: All beverages are flavor and color matched

Interventions

All beverages are flavor and color matched OTHER

Caffeine with varying amounts of taurine and B vitamins

Caffeine 120 mg beverage 1; Caffeine 120 mg beverage 2; Caffeine 120 mg beverage 3

Flavored carbonated beverage, color-matched OTHER

Base with 0 mg caffeine, taurine, vitamins

Placebo beverage

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• PepsiCo Global R&D: lead

Study Sites (1)

Northumbria U

Newcastle, Tyne, NE1 7RU, United Kingdom

RECRUITING

Study Officials

• Crystal Haskell-Ramsay, PhD

  Northumbria U Newcastle, UK

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Crystal Haskell-Ramsay, PhD

CONTACT

(44) 191 2048818; crystal.haskell-ramsay@northumbria.ac.uk

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: February 3, 2026
• First Posted: February 10, 2026
• Study Start: January 26, 2026
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)