Electrical Alternation of Heart, Blood Pressure
Conditions
Keywords
ECG, Blood Pressure, Energy Drinks, Panax Ginseng
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.
Interventions
DIETARY_SUPPLEMENTEnergy Drink
Energy Drink, two 16oz containers consumed in 45 minutes
DIETARY_SUPPLEMENTPanax Ginseng
Panax Ginseng, lime juice, water and cherry flavoring
OTHERPlacebo
Lime juice, water and cherry flavoring
Sponsors
University of the Pacific
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| QTc interval changes | 5.5 hours over 3 visits |
| Systolic blood pressure changes | 5.5 hours over 3 visits |
Secondary
| Measure | Time frame |
|---|---|
| QRS duration changes | 5.5 hours over 3 visits |
| QT interval 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 |
| PR interval changes | 5.5 hours over 3 visits |
Outcome results
None listed