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To assess the cardiac effects of energy drink brands in healthy volunteers
Energy drinks are widely available and globally consumed. There are many brands of energy drinks on the market, and there are differences in the ingredients included. Previous studies have tried to evaluate the safety of energy drinks and have demonstrated a signal for some electrocardiographic (ECG) and hemodynamic effects. However, product related differences need further exploration. This study is designed to assess the effects of 2 different energy drink products on heart rhythm and blood pressure in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Energy Drink Brand 1 | Experimental | Two 16-oz bottles of Energy Drink Brand 1 |
|
| Energy Drink Brand 2 | Experimental | Two 16-oz bottles of Energy Drink Brand 2 |
|
| Placebo | Placebo Comparator | Two 16-oz bottles that each contain 390 ml of carbonated water, 20 ml of reconstituted lime juice, and 70 ml of cherry flavoring |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Energy Drink Brand 1 | Dietary Supplement | Two 16-oz containers of Energy Drink Brand 1 consumed in 60 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Corrected QT (QTc) Interval | Electrocardiograph (ECG) Parameters | 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| QT | Electrocardiograph (ECG) Parameters | 4 hours |
| PR | Electrocardiograph (ECG)Parameters | 4 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sachin Shah, PharmD | University of the Pacific | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of the Pacific | Stockton | California | 95211 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31137991 | Derived | Shah SA, Szeto AH, Farewell R, Shek A, Fan D, Quach KN, Bhattacharyya M, Elmiari J, Chan W, O'Dell K, Nguyen N, McGaughey TJ, Nasir JM, Kaul S. Impact of High Volume Energy Drink Consumption on Electrocardiographic and Blood Pressure Parameters: A Randomized Trial. J Am Heart Assoc. 2019 Jun 4;8(11):e011318. doi: 10.1161/JAHA.118.011318. Epub 2019 May 29. |
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| Energy Drink Brand 2 | Dietary Supplement | Two 16-oz containers of Energy Drink Brand 2 consumed in 60 minutes |
|
| Placebo | Other | Lime juice, water, and cherry flavoring |
|
| QRS | Electrocardiograph (ECG) Parameters | 4 hours |
| Heart Rate (HR) | Electrocardiograph (ECG) Parameters | 4 hours |
| Central blood pressure | Hemodynamic Parameters | 4 hours |
| Peripheral blood pressure | Hemodynamic Parameters | 4 hours |