Impact of Energy Drinks and Panax Ginseng on Heart Rhythm

Not Applicable

• Conditions: Electrical Alternation of Heart; Blood Pressure
• Interventions: Other: Placebo; Dietary Supplement: Panax Ginseng; Dietary Supplement: Energy Drink

• Registration Number: NCT02572102
• Lead Sponsor: University of the Pacific

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2015-06
• Status Verified: 2015-10
• Study First Submitted: 2015-10-06
• Study First Submitted QC: 2015-10-07
• Last Update Submitted: 2015-10-07
• Study First Posted: 2015-10-08
• Last Update Posted: 2015-10-08
• Primary Completion: 2016-03
• Study Completion: 2016-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	70 mL of cherry syrup, 20 mL of lime juice, 410 mL of carbonated water
Panax Ginseng	Panax Ginseng	800 mg of Panax Ginseng in 70 mL of cherry syrup, 20 mL of lime juice, 410 mL of carbonated water
Energy Drink	Energy Drink	Two 16 ounce containers of an Energy Drink

Primary Outcome Measures

Name	Time	Method
QTc interval changes	5.5 hours over 3 visits
Systolic blood pressure changes	5.5 hours over 3 visits

Secondary Outcome Measures

Name	Time	Method
QT interval changes	5.5 hours over 3 visits
PR interval changes	5.5 hours over 3 visits
QRS duration changes	5.5 hours over 3 visits
Diastolic blood pressure changes	5.5 hours over 3 visits
Heart rate changes	5.5 hours over 3 visits