An interventional study of Commercially-Available Energy Drink in Cardiovascular Diseases, sponsored by University of the Pacific. Completed at 1 site in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-06.
Sponsored by University of the Pacific · Not applicable, Interventional, and Prevention
Many people use energy drinks (EDs) regularly, but the overall health concerns are still unknown. There are many energy drink products that contain a mixture of caffeine and other energy-boosting ingredients and supplements which can affect parameters related to the heart, blood pressure and blood glucose. Several previous studies have shown that energy drinks may affect heart rhythm and blood pressure significantly. As energy drinks are sugar-sweetened beverages, long-term use may also affect the body's metabolism, including cholesterol, blood sugars, and weight.
The purpose of this study is to learn if drinking energy drinks everyday may affect a person's cardiometabolic health.
The popularity of energy drinks (EDs) have increased over the last few decades due to their purported benefits as mental and physical performance enhancements. While caffeine is a major ingredient in most EDs (ranging from 80 mg to 500 mg per drink), they may also contain various supplements, such as guarana, taurine, ginseng, B vitamins, gluconolactone, yohimbe, carnitine, and bitter orange, as well as high amount of sugar (ranging from 25-50 grams). The United States Food and Drug Administration (FDA) has cited that a daily intake of 400 mg caffeine (approximately 4-5 cups of coffee) in adults is generally safe and not associated with dangerous, negative effects. The Substance Abuse and Mental Health Services Administration reported a doubling of emergency department visits involving EDs from 10,068 visits in 2007 to 20,783 visits in 2011. Commonly reported adverse reactions include insomnia, nervousness, headache, tachycardia, and seizures. Currently, the health effects of long-term ED use remain unknown.
This study is a proof-of-concept, prospective trial that aims to evaluate the effects of chronic ED consumption on cardiometabolic parameters in a healthy population. Subjects will consume two cans (16 oz.) of an energy drink daily for 4 weeks. The study will assess any changes in blood pressure (BP), electrocardiographic (ECG) parameters, blood glucose, cholesterol, weight, body mass index (BMI), and body fat composition before and after consuming EDs for 4 weeks.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's enrollment of 15 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
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Exclusion Criteria:
Healthy volunteers willing to consume two cans of energy drinks (16 oz./can) daily for 4 weeks
Dietary Supplement: Commercially-Available Energy Drink
Participant will consume 2 cans of an energy drink (16 oz./can) per day. One in the morning and one in the afternoon.
Change in blood pressure before and 1 hour after energy drink consumption
Measuring acute changes in peripheral systolic blood pressure before and 1 hour after energy drink consumption
Time frame: 1 hour
Change in blood pressure before and after 4 weeks of energy drink consumption
Measuring chronic changes in peripheral systolic blood pressure before and 4 weeks after energy drink consumption
Time frame: 4 weeks
Change in QTc Interval before and after 1 hour of energy drink consumption
Measuring change in QTc interval via electrocardiogram before and after 1 hour of energy drink consumption
Time frame: 1 hour
Change in QTc Interval before and after 4 weeks of energy drink consumption
Measuring change in QTc interval via electrocardiogram before and after 4 weeks of energy drink consumption
Time frame: 4 weeks
Change in fasting blood glucose before and after 4 weeks of energy drink consumption
Measuring the change in fasting blood glucose before and after 4 weeks of energy drink consumption
Time frame: 4 weeks
Change in fasting lipid panel parameters before and after 4 weeks of energy drink consumption
Measuring the changes in total cholesterol (TC), high-density lipoprotein (HDL), triglyceride (TG), and calculated low-density lipoprotein (LDL-C) levels before and after 4 weeks of energy drink consumption
Time frame: 4 weeks
Change in Body Mass Index before and after 4 weeks of energy drink consumption
Measuring the change in Body Mass Index (BMI) before and after 4 weeks of energy drink consumption
Time frame: 4 weeks
Change in Body Fat Analysis before and after 4 weeks of energy drink consumption
Measuring the changes in Body Fat Analysis before and after 4 weeks of energy drink consumption, including percentage of body fat, fat mass, muscle mass, and fat in trunk
Time frame: 4 weeks
Change in Serum Creatinine before and after 4 weeks of energy drink consumption
Measuring the change in Serum Creatinine before and after 4 weeks of energy drink consumption
Time frame: 4 weeks
Plan to share: No
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This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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University of the Pacific