Evaluation of Energy Drinks on Electrocardiographic Parameters: A Randomized, Double Blind, Controlled, Crossover, Proof-of-concept Study
University of the Pacific
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.
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 in…
Eligibility
- Age range
- 18–40 years
- Sex
- All
- Healthy volunteers
- Yes
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)…
Interventions
- Dietary SupplementEnergy Drink A + Placebo Capsule
1000 mL caffeine- and taurine-containing commercially available beverage (Formula A) consumed with placebo capsule
- DrugPlacebo Drink + Moxifloxacin Capsule
Placebo drink with 400 mg moxifloxacin capsule
- Dietary SupplementPlacebo Drink + Caffeine Capsule
Placebo drink with 320 mg caffeine capsule
- OtherPlacebo Drink + Placebo Capsule
Placebo drink with placebo capsule
- Dietary SupplementEnergy Drink B
568 mL caffeine- and taurine-containing commercially available beverage (Formula B)
- Dietary SupplementControl Product + Taurine
Control product with 4000 mg taurine powder
Location
- University of the PacificStockton, California