How different energy drink formulas affect alertness over five hours

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

This test will see if flavored carbonated energy drinks with 120 mg of caffeine and different amounts of taurine and B vitamins help healthy adults (18–49) feel more alert over five hours while doing short thinking tasks.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years to 49 Years
• Sex: All
• Sponsor: PepsiCo Global R&D (industry)
• Locations: 1 site (Newcastle, Tyne)
• Trial ID: NCT07400614 on ClinicalTrials.gov

What this trial studies

Healthy adults aged 18–49 who are regular caffeine consumers will drink flavor- and color-matched carbonated beverages that each contain 120 mg of caffeine but vary in taurine and B vitamin content. Subjective alertness is measured hourly for up to five hours after dosing while participants complete cognitive-load tasks. Participants must follow pre-visit restrictions such as short-term caffeine and medication abstinence and maintain usual diet and activity patterns during the study period. The study is sponsored by PepsiCo Global R&D and conducted at Northumbria University in Newcastle upon Tyne.

Who should consider this trial

Good fit: Ideal participants are healthy adults aged 18–49 who regularly consume at least one caffeinated beverage per day and can follow short-term abstinence rules for caffeine, alcohol, and certain medications before test visits.

Not a fit: People younger than 18 or older than 49, non-regular caffeine users, those with health conditions or on medications that cannot be paused, or those unable to travel to the study site are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the results could help people choose energy drink formulas that give more sustained alertness over several hours.

How similar studies have performed: Caffeine is well established to increase alertness in many studies, but the additional and sustained effects of varying taurine and B vitamin levels are less well established.

Eligibility criteria

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

Where this trial is running

Newcastle, Tyne

• Northumbria U — Newcastle, Tyne, United Kingdom (RECRUITING)

Study contacts

• Principal investigator: Crystal Haskell-Ramsay, PhD — Northumbria U Newcastle, UK
• Study coordinator: Crystal Haskell-Ramsay, PhD

Conditions: Alertness, alertness, energy, caffeine, beverage