Impact of Energy Drinks and Panax Ginseng on Heart Rhythm

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

Detailed Description
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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.

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

Conditions
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Electrical Alternation of Heart, Blood Pressure

Intervention / Treatment
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* Dietary Supplement: Energy Drink
* Dietary Supplement: Panax Ginseng
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Energy Drink<br>Two 16 ounce containers of an Energy Drink | Dietary Supplement: Energy Drink<br>* Energy Drink, two 16oz containers consumed in 45 minutes<br>|
| Active Comparator: Panax Ginseng<br>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<br>* Panax Ginseng, lime juice, water and cherry flavoring<br>|
| Placebo Comparator: Placebo<br>70 mL of cherry syrup, 20 mL of lime juice, 410 mL of carbonated water | Other: Placebo<br>* Lime juice, water and cherry flavoring<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ECG, Blood Pressure, Energy Drinks, Panax Ginseng