Effects of Chronic Energy Drink Consumption on Cardiometabolic Endpoints
| Status: | Recruiting |
|---|---|
| Conditions: | Peripheral Vascular Disease |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 40 |
| Updated: | 3/22/2019 |
| Start Date: | March 6, 2019 |
| End Date: | December 2019 |
| Contact: | May Chen, PharmD |
| Email: | mchen2@pacific.edu |
| Phone: | 209 932 2959 |
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.
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.
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.
Inclusion Criteria:
- Healthy adults aged 18 - 40 years
- Participants willing to adhere to study drink schedule (28 days)
Exclusion Criteria:
- Naïve caffeine consumers (< 2 cups of coffee [or equivalent caffeine intake] per week)
- Chronic medical conditions including cardiovascular disease (known history of cardiac
arrhythmias, family history of premature sudden cardiac death before age 60,
cardiomyopathy, atherosclerosis), smoking, renal or hepatic dysfunction
- Prolonged corrected QT (QTc) interval
- History of substance abuse, including alcohol
- Concurrent use of prescription drugs or over-the-counter products that may interact
with study drinks (with the exception of oral contraceptives that have been used for
over 1 month)
- Baseline Blood Pressure greater than 140/90 mmHg
- Baseline fasting blood glucose greater than 126 mg/dL or random blood glucose greater
than 200 mg/dL
- Females only: pregnancy or lactation, or planning to get pregnant within next 28 days
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