Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
3 participants
INTERVENTIONAL
2025-11-01
2026-09-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
QUADRUPLE
Study Groups
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Phase B: Lower Dose Energy Drink A
Energy Drink A (189 mg caffeine)
Lower Dose Energy Drink A
591 mL caffeine- and taurine-containing commercially available beverage (Formula A)
Phase A: Energy Drink A + Placebo
Energy Drink A (320 mg caffeine) consumed with placebo capsule
Energy Drink A + Placebo Capsule
1000 mL caffeine- and taurine-containing commercially available beverage (Formula A) consumed with placebo capsule
Phase A: Placebo Drink + Moxifloxacin
Placebo drink with 400 mg moxifloxacin capsule
Placebo Drink + Moxifloxacin Capsule
Placebo drink with 400 mg moxifloxacin capsule
Phase A: Placebo Drink + Caffeine
Placebo drink with 320 mg caffeine capsule
Placebo Drink + Caffeine Capsule
Placebo drink with 320 mg caffeine capsule
Phase A: Placebo Drink + Placebo Capsule
Placebo drink with Placebo capsule
Placebo Drink + Placebo Capsule
Placebo drink with placebo capsule
Phase B: Energy Drink B
Energy Drink B (320 mg caffeine)
Energy Drink B
568 mL caffeine- and taurine-containing commercially available beverage (Formula B)
Phase B: Control + Taurine
Control product with 4000 mg taurine powder
Control Product + Taurine
Control product with 4000 mg taurine powder
Phase B: Control + Caffeine + Taurine
Control product with 320 mg caffeine + 4000 mg taurine powder
Control Product + Caffeine + Taurine
Control product with 320 mg caffeine + 4000 mg taurine powder
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
40 Years
ALL
Yes
Sponsors
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University of the Pacific
OTHER
Responsible Party
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Sachin Shah
Professor of Pharmacy Practice
Locations
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University of the Pacific
Stockton, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB2025-207
Identifier Type: -
Identifier Source: org_study_id
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