Impact of Energy Drink Brands on Heart Rhythm in Healthy Volunteers: A Randomized Controlled Trial
| Registry | NCT03196908 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, crossover, masking: double, other |
| Enrollment | 40 (Actual) |
| Sponsor | University of the Pacific (Other) |
| Conditions | Electrical Alternation of Heart, Blood Pressure |
| Interventions | Energy Drink Brand 1, Energy Drink Brand 2, Placebo (Dietary supplement, other) |
| Dates | start 2017-07-01, primary completion 2017-12-30, completion 2017-12-30, first posted 2017-06-23, last updated 2018-12-24 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Electrical Alternation of Heart All trials for Blood Pressure All trials of Energy Drink Brand 1 All trials of Energy Drink Brand 2
To assess the cardiac effects of energy drink brands in healthy volunteers
Energy drinks are widely available and globally consumed. There are many brands of energy drinks on the market, and there are differences in the ingredients included. Previous studies have tried to evaluate the safety of energy drinks and have demonstrated a signal for some electrocardiographic (ECG) and hemodynamic effects. However, product related differences need further exploration. This study is designed to assess the effects of 2 different energy drink products on heart rhythm and blood pressure in healthy subjects.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Energy Drink Brand 1 | Experimental | Dietary Supplement: Energy Drink Brand 1 | Two 16-oz bottles of Energy Drink Brand 1 |
| Energy Drink Brand 2 | Experimental | Dietary Supplement: Energy Drink Brand 2 | Two 16-oz bottles of Energy Drink Brand 2 |
| Placebo | Placebo comparator | Other: Placebo | Two 16-oz bottles that each contain 390 ml of carbonated water, 20 ml of reconstituted lime juice, and 70 ml of cherry flavoring |
Sex: All, ages: 18 Years to 40 Years, accepts healthy volunteers
Inclusion Criteria: * Healthy male or female adults 18 - 40 years old * Participants must be willing to refrain from caffeine and alcohol use ≥48 hours prior to sessions on Day 1, 8, and 15 Exclusion Criteria: * Presence of any known medical condition confirmed through participant interview * QTc interval greater than 450 milliseconds (ms). * Blood pressure greater than 140/90 mmHg. * Current smokers * Concurrent use of prescription, over-the-counter (OTC) or herbal supplements taken on a daily basis (except oral contraceptives). * Pregnant or currently breast-feeding
| Facility | City | Country | Status |
|---|---|---|---|
| University of the Pacific | Stockton, California | United States |