Effects of Chronic Energy Drink Consumption on Cardiometabolic Endpoints

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Dietary supplement: Commercially-Available Energy Drink

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stockton, California, United States, 95211
      • University of the Pacific

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Commercially-Available Energy drink; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	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	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	4 weeks

Collaborators and Investigators

• Sponsor: University of the Pacific
• Investigators: Principal Investigator: May Chen, PharmD, University of the Pacific

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2019
• Primary Completion (Actual): June 20, 2019
• Study Completion (Actual): July 30, 2020

Study Registration Dates

• First Submitted: January 11, 2019
• First Submitted That Met QC Criteria: February 12, 2019
• First Posted (Actual): February 15, 2019

Study Record Updates

• Last Update Posted (Actual): November 6, 2020
• Last Update Submitted That Met QC Criteria: November 5, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Arrhythmia; Blood Pressure; Energy Drink
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 19-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No