NCT07212803

Effects of Energy Drinks on Cardiovascular Endpoints

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 3 (estimated)
• Sponsor: University of the Pacific · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Healthy Volunteers
• Safety After Oral Intake

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Energy Drink A + Placebo Capsule	1000 mL caffeine- and taurine-containing commercially available beverage (Formula A) consumed with placebo capsule
DRUG	Placebo Drink + Moxifloxacin Capsule	Placebo drink with 400 mg moxifloxacin capsule
DIETARY_SUPPLEMENT	Placebo Drink + Caffeine Capsule	Placebo drink with 320 mg caffeine capsule
OTHER	Placebo Drink + Placebo Capsule	Placebo drink with placebo capsule
DIETARY_SUPPLEMENT	Energy Drink B	568 mL caffeine- and taurine-containing commercially available beverage (Formula B)
DIETARY_SUPPLEMENT	Control Product + Taurine	Control product with 4000 mg taurine powder
DIETARY_SUPPLEMENT	Control Product + Caffeine + Taurine	Control product with 320 mg caffeine + 4000 mg taurine powder
DIETARY_SUPPLEMENT	Lower Dose Energy Drink A	591 mL caffeine- and taurine-containing commercially available beverage (Formula A)

Timeline

• Start date: 2025-11-01
• Primary completion: 2026-03-01
• Completion: 2026-09-01
• First posted: 2025-10-08
• Last updated: 2025-11-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study