University of the Pacific
Stockton, California, 95211, United States
NCT Number: NCT03840863
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.
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Notify Me18 year–40 year
All sexes
Interventional
Not applicable
Stockton, California, 95211, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participant will consume 2 cans of an energy drink (16 oz./can) per day. One in the morning and one in the afternoon.
Time frame: 1 hour
Measuring acute changes in peripheral systolic blood pressure before and 1 hour after energy drink consumption
Time frame: 4 weeks
Measuring chronic changes in peripheral systolic blood pressure before and 4 weeks after energy drink consumption
Time frame: 1 hour
Measuring change in QTc interval via electrocardiogram before and after 1 hour of energy drink consumption
Time frame: 4 weeks
Measuring change in QTc interval via electrocardiogram before and after 4 weeks of energy drink consumption
Time frame: 4 weeks
Measuring the change in fasting blood glucose before and after 4 weeks of energy drink consumption
Time frame: 4 weeks
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
Measuring the change in Body Mass Index (BMI) before and after 4 weeks of energy drink consumption
Time frame: 4 weeks
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
Measuring the change in Serum Creatinine before and after 4 weeks of energy drink consumption
University of the Pacific
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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