Effects of Energy Drinks on Cardiovascular Endpoints

NCT07212803 | Recruiting Phase 4 FDA Drug

• 1 other identifier: IRB2025-207
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers; Safety After Oral Intake

Keywords

Energy Drinks

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Corrected QT Interval (QTc) in Milliseconds (ms)

  QTc interval will be calculated using both Bazett's and Fridericia's correction formulas assessed via 12-lead ECG.

  Baseline, 30, 60, 90, 120, 150, 180, and 240 minutes post-intervention

Secondary Outcomes (11)

• Change from Baseline in QT Interval in Milliseconds (ms)

  Baseline, 30, 60, 90, 120, 150, 180, and 240 minutes post-intervention

• Change from Baseline in RR Interval in Milliseconds (ms)

  Baseline, 30, 60, 90, 120, 150, 180, and 240 minutes post-intervention

• Change from Baseline in PR Interval in Milliseconds (ms)

  Baseline, 30, 60, 90, 120, 150, 180, and 240 minutes post-intervention

• Change from Baseline in QRS Duration in Milliseconds (ms)

  Baseline, 30, 60, 90, 120, 150, 180, and 240 minutes post-intervention

• Change from Baseline in Systolic Blood Pressure (SBP) in Millimeters of Mercury (mmHg)

  Baseline, 30, 60, 90, 120, 150, 180, and 240 minutes post-intervention

Study Arms (8)

Phase A: Energy Drink A + Placebo

EXPERIMENTAL

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

Dietary Supplement: Energy Drink A + Placebo Capsule

Phase A: Placebo Drink + Moxifloxacin

ACTIVE COMPARATOR

Placebo drink with 400 mg moxifloxacin capsule

Drug: Placebo Drink + Moxifloxacin Capsule

Phase A: Placebo Drink + Caffeine

ACTIVE COMPARATOR

Placebo drink with 320 mg caffeine capsule

Dietary Supplement: Placebo Drink + Caffeine Capsule

Phase A: Placebo Drink + Placebo Capsule

PLACEBO COMPARATOR

Placebo drink with Placebo capsule

Other: Placebo Drink + Placebo Capsule

Phase B: Energy Drink B

EXPERIMENTAL

Energy Drink B (320 mg caffeine)

Dietary Supplement: Energy Drink B

Phase B: Control + Taurine

EXPERIMENTAL

Control product with 4000 mg taurine powder

Dietary Supplement: Control Product + Taurine

Phase B: Control + Caffeine + Taurine

EXPERIMENTAL

Control product with 320 mg caffeine + 4000 mg taurine powder

Dietary Supplement: Control Product + Caffeine + Taurine

Phase B: Lower Dose Energy Drink A

EXPERIMENTAL

Energy Drink A (189 mg caffeine)

Dietary Supplement: Lower Dose Energy Drink A

Interventions

Energy Drink A + Placebo Capsule DIETARY_SUPPLEMENT

1000 mL caffeine- and taurine-containing commercially available beverage (Formula A) consumed with placebo capsule

Phase A: Energy Drink A + Placebo

Placebo Drink + Moxifloxacin Capsule DRUG

Placebo drink with 400 mg moxifloxacin capsule

Phase A: Placebo Drink + Moxifloxacin

Placebo Drink + Caffeine Capsule DIETARY_SUPPLEMENT

Placebo drink with 320 mg caffeine capsule

Phase A: Placebo Drink + Caffeine

Placebo Drink + Placebo Capsule OTHER

Placebo drink with placebo capsule

Phase A: Placebo Drink + Placebo Capsule

Energy Drink B DIETARY_SUPPLEMENT

568 mL caffeine- and taurine-containing commercially available beverage (Formula B)

Phase B: Energy Drink B

Control Product + Taurine DIETARY_SUPPLEMENT

Control product with 4000 mg taurine powder

Phase B: Control + Taurine

Control Product + Caffeine + Taurine DIETARY_SUPPLEMENT

Control product with 320 mg caffeine + 4000 mg taurine powder

Phase B: Control + Caffeine + Taurine

Lower Dose Energy Drink A DIETARY_SUPPLEMENT

591 mL caffeine- and taurine-containing commercially available beverage (Formula A)

Phase B: Lower Dose Energy Drink A

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of the Pacific: lead

Study Sites (1)

University of the Pacific

Stockton, California, 95211, United States

RECRUITING

MeSH Terms

Interventions

Moxifloxacin; Caffeine; Control Groups; Taurine

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Xanthines; Alkaloids; Purinones; Purines; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Central Study Contacts

Quy Phan, PharmD

CONTACT

209-946-7754; qphan@pacific.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pharmacy Practice

Model Details: Randomized, Double-Blind, Controlled, Crossover Study

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: October 8, 2025
• Study Start: November 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)