NCT03841838

The Effect of Energy Drink on Cardiovascular Variables: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of the Pacific · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

Many adults in the United States regularly consumer energy drinks. Currently, the safety of energy drinks is still questionable and there are many reports associating energy drinks with adverse events including hospitalizations and deaths. Previous research shows that energy drink can affect heart rhythm and elevate blood pressure. However, these studies use a higher volume (32 ounces) of energy drinks than those available in the market (24 ounces). The purpose of this study is to study if 24-ounce energy drinks can significantly affect heart rhythm and elevate blood pressure when compared to a placebo.

Detailed description

The study is a randomized, double blind, controlled, crossover study comparing the effect of energy drinks and placebo on cardiovascular parameters including heart rhythm and blood pressure. Subjects who contact the PI for interest in study participation will be scheduled a time to study facility for initial evaluation on eligibility criteria. At initial evaluation, participants will be informed about the study details, presented with Informed Consent Document (ICD), and be asked to sign the appropriate forms voluntarily if they decide to participate. Once consented, participants will be asked a series of questions and screened for blood pressure and heart rhythm parameters to determine eligibility to enroll. If patient is eligible to enroll, they will be allocated a randomized identification number. Participants will be randomly assigned to consume either two-12 oz bottles of energy drink and two-12 oz bottles of control drink on 2 separate days. The study will occur over approximately 8 days with each session taking about 5 hours per day. Each session will have 6 days between each other. Participants will be expected to refrain from any products containing caffeine or alcohol 48 hours and fast 10 hours before each study visit. At the beginning of each study visit, baseline measurements of ECG, blood pressures, and heart rate will be obtained prior to consuming study drinks. Repeat measurements will be obtained every 60 minutes after consumption over 4 hours.

Conditions

• Cardiovascular Diseases

Interventions

Type	Name	Description
OTHER	Energy drink	Two 12 oz bottles of commercially available energy drink
OTHER	Placebo drink	Two 12 oz bottles placebo drink. Placebo drink will contain carbonated water, lime juice, and cherry flavoring.

Timeline

• Start date: 2019-02-23
• Primary completion: 2019-05-09
• Completion: 2019-05-09
• First posted: 2019-02-15
• Last updated: 2019-09-25

Locations

1 site across 1 country: United States