How energy drinks affect heart rhythm, blood pressure, and related cardiovascular measures

Evaluation of Energy Drinks on Electrocardiographic Parameters: A Randomized, Double Blind, Controlled, Crossover, Proof-of-concept Study

This trial will test whether different energy drinks and their ingredients change heart rhythm and other cardiovascular measures in healthy adults ages 18 to 40.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 3 (estimated)
• Ages: 18 Years to 40 Years
• Sex: All
• Sponsor: University of the Pacific (Academic / other)
• Locations: 1 site (Stockton, California)
• Trial ID: NCT07212803 on ClinicalTrials.gov

What this trial studies

This randomized, double-blind, placebo-controlled, crossover proof-of-concept trial enrolls three healthy adults who each receive eight different interventions across two phases. Phase A compares energy drink A, moxifloxacin, caffeine, and placebo, while Phase B compares energy drink B, taurine, caffeine plus taurine, and a lower-dose energy drink A. After an overnight fast participants consume the assigned beverage within 30 minutes and are monitored for four hours with repeated ECGs (including QTc), blood pressure, hemodynamics, glucose, endothelial function, and side-effect checks while maintaining minimal activity. The crossover design and inclusion of pharmacologic comparators aim to detect acute cardiovascular and rhythm changes from the beverages and ingredients.

Who should consider this trial

Good fit: Ideal candidates are healthy men or women aged 18–40 who can fast, avoid caffeine and alcohol for 72 hours before visits, swallow a capsule, drink up to 1 liter within 30 minutes, and maintain active health insurance during the study.

Not a fit: People with known heart disease, a prolonged QTc interval, significant medical conditions, pregnancy, or those older than 40 are unlikely to benefit or be eligible for this protocol.

Why it matters

Potential benefit: If successful, the results could clarify short-term heart-rhythm and blood-pressure effects of common energy drinks and their ingredients, helping inform safer use and labeling.

How similar studies have performed: Prior small studies have shown that some energy drinks can raise heart rate and blood pressure and occasionally affect QTc, but findings have been inconsistent, so the area is somewhat studied but still uncertain.

Eligibility criteria

Inclusion Criteria:

* Healthy male or female adults 18-40 years of age
* Female participants of child-bearing potential must have a negative pregnancy test at the baseline visit
* Participants must be willing to refrain from caffeine and alcohol use 72 hours prior to sessions on study days
* Participants must be willing and able to: (1.) Consume up to 1 liter of fluid within a 30-minute period per visit (2.) Swallow a single large capsule per visit
* Participants must be willing to fast 10 hours prior to sessions on study days (only water is allowed during the fasting and active study period)
* Participants must have active health insurance throughout the duration of the study

Exclusion Criteria:

* Have a corrected QT (QTc) interval greater than 450 milliseconds (ms) for males or greater than 470 milliseconds (ms) for females, determined during the baseline visit
* Presence of any known medical condition, confirmed through participant interview. Examples of these include but not limited to: Dyslipidemia, Thyroid disease, Diabetes, Recurrent headache, Any psychiatric condition or neurological disorder, History of alcohol or drug abuse, Past diagnosis or history of renal insufficiencies, Hepatic dysfunction, Electrolyte imbalances requiring hospitalization
* Presence of any known heart/cardiac diseases or conditions such as: Atrial Fibrillation, History of stroke or heart attack, Hypertension, Heart Failure, Vascular Disease, Family history/Active Long QT Syndrome, Coronary artery disease, Cardiomyopathy, Valvular heart disease, Ventricular arrhythmia, Congenital heart defect, Pericardial disease, Myocarditis
* Study physician recommendation for participant to not be enrolled.
* Are underweight (BMI\<18.5 kg/m2, CDC 2024), have poor eating habits resulting in poor weight control, or have any factors that will put the participant at risk from fasting.
* Have any contraindications to the use of moxifloxacin, including a past medical history of myasthenia gravis, QT prolongation, or hypersensitivities and allergic reactions to moxifloxacin or any other fluoroquinolone antibiotics
* Pre-existing risk to tendinitis and tendon rupture, peripheral neuropathy, or central nervous system side effects
* Concurrent use of ANY medication taken daily including herbal products or supplements (daily basis is defined as greater than 2 days per week)
* Self-reported allergy to taurine
* Self-reported allergy to nuts (peanuts, pecans, cashews, etc.)
* Self-reported allergic reaction to the adhesive pads (electrodes, continuous glucose monitors, etc.)
* Fear of needle puncture
* Smokers using cigarettes, vaporized nicotine, or marijuana products currently or within the past month
* Current usage of any nicotine or tobacco products including but not limited to intranasal, sublingual, oral, or transdermal dosage forms
* Currently pregnant or breastfeeding
* Have a positive pregnancy test during the baseline visit
* Are currently enrolled in any other clinical study or have participated in another study within the last 30 days
* Non-English speaking/reading individuals will be excluded due to the unavailability of medically qualified translators throughout all study procedures
* If the candidate does not sign the informed consent document

Where this trial is running

Stockton, California

• University of the Pacific — Stockton, California, United States (Recruiting)

Study contacts

• Study coordinator: Quy Phan, PharmD

Conditions Healthy Volunteers; Safety After Oral Intake; Energy Drinks