Overview

This trial is active, not recruiting.

Conditions electrical alternation of heart, blood pressure
Treatments energy drink, panax ginseng, placebo
Sponsor University of the Pacific
Start date June 2015
End date March 2016
Trial size 30 participants
Trial identifier NCT02572102, 15-119

Summary

To assess the cardiac effects of an energy drink and Panax Ginseng in healthy volunteers.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model crossover assignment
Masking double blind (subject, investigator)
Arm
(Experimental)
Two 16 ounce containers of an Energy Drink
energy drink
Energy Drink, two 16oz containers consumed in 45 minutes
(Active Comparator)
800 mg of Panax Ginseng in 70 mL of cherry syrup, 20 mL of lime juice, 410 mL of carbonated water
panax ginseng
Panax Ginseng, lime juice, water and cherry flavoring
(Placebo Comparator)
70 mL of cherry syrup, 20 mL of lime juice, 410 mL of carbonated water
placebo
Lime juice, water and cherry flavoring

Primary Outcomes

Measure
QTc interval changes
time frame: 5.5 hours over 3 visits
Systolic blood pressure changes
time frame: 5.5 hours over 3 visits

Secondary Outcomes

Measure
QT interval changes
time frame: 5.5 hours over 3 visits
PR interval changes
time frame: 5.5 hours over 3 visits
QRS duration changes
time frame: 5.5 hours over 3 visits
Heart rate changes
time frame: 5.5 hours over 3 visits
Diastolic blood pressure changes
time frame: 5.5 hours over 3 visits

Eligibility Criteria

Male or female participants from 18 years up to 40 years old.

Inclusion Criteria: - Healthy male or female adults 18-40 years old. Exclusion Criteria: - Baseline corrected QT (QTc) interval greater than 440 milliseconds, - blood pressure at initial screening appointment greater than 140/90 mmHg, - concurrent use of prescriptions or OTC medications taken on a daily basis, - pregnant females, - patients with any baseline ECG abnormalities.

Additional Information

Official title Impact of Energy Drinks and Panax Ginseng on Heart Rhythm in Healthy Volunteers
Description Energy drinks are composed of a variety of ingredients such as caffeine, taurine, and panax ginseng amongst others. The safety and efficacy of these ingredients individually and in combination need further exploration. This study is designed to assess the electrocardiographic and blood pressure effects of energy drinks and panax ginseng in healthy volunteers.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by University of the Pacific.