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Many adults in the United States regularly consumer energy drinks. Currently, the safety of energy drinks is still questionable and there are many reports associating energy drinks with adverse events including hospitalizations and deaths. Previous research shows that energy drink can affect heart rhythm and elevate blood pressure. However, these studies use a higher volume (32 ounces) of energy drinks than those available in the market (24 ounces). The purpose of this study is to study if 24-ounce energy drinks can significantly affect heart rhythm and elevate blood pressure when compared to a placebo.
The study is a randomized, double blind, controlled, crossover study comparing the effect of energy drinks and placebo on cardiovascular parameters including heart rhythm and blood pressure.
Subjects who contact the PI for interest in study participation will be scheduled a time to study facility for initial evaluation on eligibility criteria. At initial evaluation, participants will be informed about the study details, presented with Informed Consent Document (ICD), and be asked to sign the appropriate forms voluntarily if they decide to participate. Once consented, participants will be asked a series of questions and screened for blood pressure and heart rhythm parameters to determine eligibility to enroll. If patient is eligible to enroll, they will be allocated a randomized identification number.
Participants will be randomly assigned to consume either two-12 oz bottles of energy drink and two-12 oz bottles of control drink on 2 separate days. The study will occur over approximately 8 days with each session taking about 5 hours per day. Each session will have 6 days between each other.
Participants will be expected to refrain from any products containing caffeine or alcohol 48 hours and fast 10 hours before each study visit. At the beginning of each study visit, baseline measurements of ECG, blood pressures, and heart rate will be obtained prior to consuming study drinks. Repeat measurements will be obtained every 60 minutes after consumption over 4 hours.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Energy drink | Experimental | Two 12 oz bottles of energy drink |
|
| Placebo | Placebo Comparator | Two 12 oz bottles of placebo drink |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Energy drink | Other | Two 12 oz bottles of commercially available energy drink |
| |
| Measure | Description | Time Frame |
|---|---|---|
| QTc interval | Maximum change in QTc interval from baseline in each of 2 arm | Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours |
| Central systolic blood pressure | Maximum change in central systolic blood pressure from baseline in each of 2 arm | Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| QT interval | Maximum change in QT interval from baseline in each of 2 arm | Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours |
| PR interval | Maximum change in PR interval from baseline in each of 2 arm |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cynthia Lee, PharmD | University of the Pacific | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pacific | Stockton | California | 95211 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28446495 | Background | 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. | |
| 27240158 | Background | Shah SA, Occiano A, Nguyen TA, Chan A, Sky JC, Bhattacharyya M, O'Dell KM, Shek A, Nguyen NN. Electrocardiographic and blood pressure effects of energy drinks and Panax ginseng in healthy volunteers: A randomized clinical trial. Int J Cardiol. 2016 Sep 1;218:318-323. doi: 10.1016/j.ijcard.2016.05.007. Epub 2016 May 13. |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D008133 | Long QT Syndrome |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D006330 | Heart Defects, Congenital |
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| ID | Term |
|---|---|
| D061215 | Energy Drinks |
| ID | Term |
|---|---|
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Placebo drink |
| Other |
Two 12 oz bottles placebo drink. Placebo drink will contain carbonated water, lime juice, and cherry flavoring. |
|
| Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours |
| QRS duration | Maximum change in QRS duration from baseline in each of 2 arm | Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours |
| Heart rate | Maximum change in heart rate from baseline in each of 2 arm | Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours |
| Central diastolic blood pressure | Maximum change in central diastolic blood pressure from baseline in each of 2 arm | Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours |
| Peripheral systolic and diastolic blood pressure | Maximum change in peripheral systolic and diastolic blood pressures in each of 2 arm | Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours |
| Augmentation index | Maximum change in augmentation index from baseline in each of 2 arm | Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours |
| 27340146 | Background | Shah SA, Chu BW, Lacey CS, Riddock IC, Lee M, Dargush AE. Impact of Acute Energy Drink Consumption on Blood Pressure Parameters: A Meta-analysis. Ann Pharmacother. 2016 Oct;50(10):808-15. doi: 10.1177/1060028016656433. Epub 2016 Jun 23. |
| 24644139 | Background | Phan JK, Shah SA. Effect of caffeinated versus noncaffeinated energy drinks on central blood pressures. Pharmacotherapy. 2014 Jun;34(6):555-60. doi: 10.1002/phar.1419. Epub 2014 Mar 19. |
| 26467367 | Background | Hajsadeghi S, Mohammadpour F, Manteghi MJ, Kordshakeri K, Tokazebani M, Rahmani E, Hassanzadeh M. Effects of energy drinks on blood pressure, heart rate, and electrocardiographic parameters: An experimental study on healthy young adults. Anatol J Cardiol. 2016 Feb;16(2):94-9. doi: 10.5152/akd.2015.5930. Epub 2015 Mar 23. |
| 25868042 | Background | Elitok A, Oz F, Panc C, Sarikaya R, Sezikli S, Pala Y, Bugan OS, Ates M, Parildar H, Ayaz MB, Atici A, Oflaz H. Acute effects of Red Bull energy drink on ventricular repolarization in healthy young volunteers: a prospective study. Anatol J Cardiol. 2015 Nov;15(11):919-22. doi: 10.5152/akd.2015.5791. Epub 2015 Mar 5. |
| D018376 | Cardiovascular Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |