Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is designed as a safety assessment to determine the cardiac and hemodynamic effects of overuse of energy drinks in healthy individuals through ECG, heart rate (HR) and blood pressure measurements. It will evaluate the use of a consumer available product that is classified as a dietary supplement by the FDA.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Energy Drink | Experimental | 16oz original flavor energy drink consume 2 -16oz energy drinks within 60 minutes |
|
| Active Control | Active Comparator | 16oz control drink: Caffeine 160mg, Sucrose 115g consume 2 - 16oz drinks within 60 minutes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Energy Drink | Dietary Supplement | 16oz energy drinks - 2 consumed within 60 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| QT/QTc measured on an office ECG | 6 hours over 5 visits |
| Measure | Description | Time Frame |
|---|---|---|
| Peripheral Blood pressure | systolic and diastolic | 6 hours with 5 visits |
| Central blood pressure | utilizing an applanation tonometry device |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Emily Fletcher, PhamD | David Grant AF Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| David Grant AF Medical Center | Travis Air Force Base | California | 94535 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28446495 | Derived | Fletcher EA, Lacey CS, Aaron M, Kolasa M, Occiano A, Shah SA. Randomized Controlled Trial of High-Volume Energy Drink Versus Caffeine Consumption on ECG and Hemodynamic Parameters. J Am Heart Assoc. 2017 Apr 26;6(5):e004448. doi: 10.1161/JAHA.116.004448. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D061215 | Energy Drinks |
| ID | Term |
|---|---|
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Active Control | Dietary Supplement | 16oz control drink: Caffeine 160mg, Sucrose 115g consume 2 - 16oz drinks within 60 minutes |
|
| 6 hours over 5 visits |
| Augmentation Index, pulse wave | 6 hours over 5 visits |