Status:
RECRUITING
Effects of Energy Drinks on Cardiovascular Endpoints
Lead Sponsor:
University of the Pacific
Conditions:
Healthy Volunteers
Safety After Oral Intake
Eligibility:
All Genders
18-40 years
Phase:
PHASE4
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.
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT07212803
Start Date
November 1 2025
End Date
September 1 2026
Last Update
November 26 2025
Active Locations (1)
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1
University of the Pacific
Stockton, California, United States, 95211