Impact of Energy Drinks and Panax Ginseng on Heart Rhythm

Impact of Energy Drinks and Panax Ginseng on Heart Rhythm in Healthy Volunteers

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

Study Overview

• Status: Unknown
• Conditions: Blood Pressure; Electrical Alternation of Heart
• Intervention / Treatment: Dietary supplement: Energy Drink; Dietary supplement: Panax Ginseng; Other: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Energy Drink; Two 16 ounce containers of an Energy Drink	Dietary supplement: Energy Drink; Energy Drink, two 16oz containers consumed in 45 minutes
Active Comparator: Panax Ginseng; 800 mg of Panax Ginseng in 70 mL of cherry syrup, 20 mL of lime juice, 410 mL of carbonated water	Dietary supplement: Panax Ginseng; Panax Ginseng, lime juice, water and cherry flavoring
Placebo Comparator: Placebo; 70 mL of cherry syrup, 20 mL of lime juice, 410 mL of carbonated water	Other: Placebo; Lime juice, water and cherry flavoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
QTc interval changes	5.5 hours over 3 visits
Systolic blood pressure changes	5.5 hours over 3 visits

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Heart rate changes	5.5 hours over 3 visits
Diastolic blood pressure changes	5.5 hours over 3 visits

Collaborators and Investigators

• Sponsor: University of the Pacific

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Anticipated): March 1, 2016
• Study Completion (Anticipated): March 1, 2016

Study Registration Dates

• First Submitted: October 6, 2015
• First Submitted That Met QC Criteria: October 7, 2015
• First Posted (Estimate): October 8, 2015

Study Record Updates

• Last Update Posted (Estimate): October 8, 2015
• Last Update Submitted That Met QC Criteria: October 7, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Blood Pressure; ECG; Energy Drinks; Panax Ginseng
• Other Study ID Numbers: 15-119