Recruiting

Energy Drinks

Sponsor:

University of the Pacific

Code:

NCT07212803

Conditions

Healthy Volunteers

Safety After Oral Intake

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Interventions

Energy Drink A + Placebo Capsule

Placebo Drink + Moxifloxacin Capsule

Placebo Drink + Caffeine Capsule

Placebo Drink + Placebo Capsule

Energy Drink B

Study Details

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

Study ID

NCT07212803

Start date

Nov 1, 2025

Status verified date

Nov, 2025

Completion date

Sep, 2026

Anticipated

Primary completion date

Mar, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

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

Study Design

Enrollment

3 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Phase A: Energy Drink A + Placebo

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

active comparator: Phase A: Placebo Drink + Moxifloxacin

Placebo drink with 400 mg moxifloxacin capsule

active comparator: Phase A: Placebo Drink + Caffeine

Placebo drink with 320 mg caffeine capsule

placebo comparator: Phase A: Placebo Drink + Placebo Capsule

Placebo drink with Placebo capsule

experimental: Phase B: Energy Drink B

Energy Drink B (320 mg caffeine)

experimental: Phase B: Control + Taurine

Control product with 4000 mg taurine powder

experimental: Phase B: Control + Caffeine + Taurine

Control product with 320 mg caffeine + 4000 mg taurine powder

experimental: Phase B: Lower Dose Energy Drink A

Energy Drink A (189 mg caffeine)

Interventions

Energy Drink A + Placebo Capsule

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

Placebo Drink + Moxifloxacin Capsule

Placebo drink with 400 mg moxifloxacin capsule

Placebo Drink + Caffeine Capsule

Placebo drink with 320 mg caffeine capsule

Placebo Drink + Placebo Capsule

Placebo drink with placebo capsule

Energy Drink B

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

Control Product + Taurine

Control product with 4000 mg taurine powder

Control Product + Caffeine + Taurine

Control product with 320 mg caffeine + 4000 mg taurine powder

Lower Dose Energy Drink A

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

Primary outcome measure

  • Change from Baseline in Corrected QT Interval (QTc) in Milliseconds (ms) [ Time Frame: Baseline, 30, 60, 90, 120, 150, 180, and 240 minutes post-intervention ]

Central Contacts and Locations

Central contacts

Quy Phan, PharmD

209-946-7754qphan@pacific.edu

Locations

University of the Pacific

Recruiting

Stockton, California, United States, 95211

Contacts

Quy Phan, PharmD

209-946-7754pharmfip@pacific.edu

More Information

Sponsor

University of the Pacific

Last update posted

Nov 26, 2025

Last verified

Nov, 2025

Keywords

  • Energy Drinks

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of the Pacific on 2025-11-26.