Effects of Energy Drinks on Cardiovascular Endpoints

University of the Pacific

Status and phase: Enrolling; Phase 4

Conditions: Healthy Volunteers; Safety After Oral Intake

Treatments: Dietary Supplement: Lower Dose Energy Drink A; Dietary Supplement: Energy Drink B; Drug: Placebo Drink + Moxifloxacin Capsule; Dietary Supplement: Control Product + Caffeine + Taurine; Dietary Supplement: Placebo Drink + Caffeine Capsule; Dietary Supplement: Control Product + Taurine; Other: Placebo Drink + Placebo Capsule; Dietary Supplement: Energy Drink A + Placebo Capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT07212803

IRB2025-207

Details and patient eligibility

About

This is a clinical trial looking at the impact of energy drinks on heart related parameters. The study will enroll 3 participants who will be exposed to 8 different interventions.

Full description

This study is a randomized, double-blind, controlled, crossover, proof-of-concept trial designed to examine how energy drinks affect heart rhythm and other health measures in healthy adults aged 18 to 40. This study investigates the cardiovascular safety of energy drinks by examining their effects on electrocardiographic parameters, with a specific focus on the QTc interval.

The protocol consists of two phases conducted with 3 healthy volunteers. Phase A (Visits 1-4) evaluates four interventions: 1) energy drink A 2) moxifloxacin 3) caffeine 4) placebo.

Phase B (Visits 5-8) evaluates four interventions: 1) energy drink B 2) taurine 3) caffeine + taurine 4) lower dose energy drink A.

After an overnight fast participants will consume the study intervention within a 30 minute period. Over the next 4 hours, the electrocardiogram, blood pressure, hemodynamics, glucose, endothelial function, and side effects will be monitored. Participants maintain minimal physical activity during this period.

Enrollment: 3 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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3 participants in 8 patient groups, including a placebo group

Phase A: Energy Drink A + Placebo

Experimental group

Description:

Energy Drink A (320 mg caffeine) consumed with placebo capsule

Treatment:

Dietary Supplement: Energy Drink A + Placebo Capsule

Phase A: Placebo Drink + Moxifloxacin

Active Comparator group

Description:

Placebo drink with 400 mg moxifloxacin capsule

Treatment:

Drug: Placebo Drink + Moxifloxacin Capsule

Phase A: Placebo Drink + Caffeine

Active Comparator group

Description:

Placebo drink with 320 mg caffeine capsule

Treatment:

Dietary Supplement: Placebo Drink + Caffeine Capsule

Phase A: Placebo Drink + Placebo Capsule

Placebo Comparator group

Description:

Placebo drink with Placebo capsule

Treatment:

Other: Placebo Drink + Placebo Capsule

Phase B: Energy Drink B

Experimental group

Description:

Energy Drink B (320 mg caffeine)

Treatment:

Dietary Supplement: Energy Drink B

Phase B: Control + Taurine

Experimental group

Description:

Control product with 4000 mg taurine powder

Treatment:

Dietary Supplement: Control Product + Taurine

Phase B: Control + Caffeine + Taurine

Experimental group

Description:

Control product with 320 mg caffeine + 4000 mg taurine powder

Treatment:

Dietary Supplement: Control Product + Caffeine + Taurine

Phase B: Lower Dose Energy Drink A

Experimental group

Description:

Energy Drink A (189 mg caffeine)

Treatment:

Dietary Supplement: Lower Dose Energy Drink A