Impact of Energy Drinks and Panax Ginseng on Heart Rhythm

Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02572102
• Other study ID #: 15-119
• Status: Active, not recruiting
• Phase: N/A
• First received: October 6, 2015
• Last updated: October 7, 2015
• Start date: June 2015
• Est. completion date: March 2016

Study information

• Verified date: October 2015
• Source: University of the Pacific
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: n/a
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Blood Pressure
• Electrical Alternation of Heart

Intervention

Dietary Supplement:
• Energy Drink
Energy Drink, two 16oz containers consumed in 45 minutes
• Panax Ginseng
Panax Ginseng, lime juice, water and cherry flavoring

Other:
• Placebo
Lime juice, water and cherry flavoring

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of the Pacific

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	QTc interval changes		5.5 hours over 3 visits	Yes
Primary	Systolic blood pressure changes		5.5 hours over 3 visits	Yes
Secondary	QT interval changes		5.5 hours over 3 visits	Yes
Secondary	PR interval changes		5.5 hours over 3 visits	Yes
Secondary	QRS duration changes		5.5 hours over 3 visits	Yes
Secondary	Heart rate changes		5.5 hours over 3 visits	Yes
Secondary	Diastolic blood pressure changes		5.5 hours over 3 visits	Yes