The Effect of Energy Drink Ingredients on Cardiovascular Function in Men and Women 18-39 Years Old

Summary

1. Statement of the research question:

Does the caffeine in energy drinks interact with other ingredients to affect cardiovascular function in healthy male and female adults after exercise?
2. Purpose and significance of the study:

Energy drinks are beverages promoted to enhance alertness along with athletic and cognitive performance. The most common ingredients found in energy drinks include water, sugar, caffeine, taurine, and B-vitamins, with variable inclusion of other ingredients, such as carnitine, glucuronolactone, inositol, guarana, ginkgo biloba leaf extract, thistle extract, and ginseng root extract. Since the mid-1990s, the consumption of energy drinks has grown dramatically, with worldwide sales in 2017 exceeding $49 billion.

As the sale of energy drinks has grown, so has the number of adverse event case reports for patients who consumed energy drinks. Reported symptoms included cardiac arrhythmias such as ventricular fibrillation, atrial fibrillation, and cardiac arrest. A few small clinical studies have found that energy drinks can increase systolic and diastolic blood pressure and change electrical activity in the heart as measured by an electrocardiogram (ECG). The intent of the proposed study is to determine whether caffeine or the combination of caffeine with taurine and L-carnitine can alter cardiovascular function. Hypothesis: The effects of the ingredients of energy drinks on the heart are mediated in part by interactions between caffeine, taurine and carnitine. The amount of each ingredient in the study was based upon the amount commonly contained in two cans of energy drinks currently on the market.

Conditions

• Cardiac Arrhythmia
• Blood Pressure

Interventions

DIETARY_SUPPLEMENT

Energy Drink Ingredients and Exercise

Subject will ingest 500 mL of one of three test solutions: A) sucrose (150g) B) sucrose (150g); caffeine (400 mg) C) sucrose (150g); caffeine (400 mg); taurine (4,000 mg); carnitine (400 mg) 3. 30 min later, subject will exercise on a treadmill using the Bruce Protocol maximum exercise test (https://www.aopa.org/go-fly/medical-resources/health-conditions/heart-and-circulatory-system/bru...). For one additional session, subjects will receive test solution C without exercise. 4\. Each stage will last 3 minutes. Stage 1 = 1.7 mph at 2% Grade Stage 2 = 2.5 mph at 4% Grade Stage 3 = 3.4 mph at 6% Grade Stage 4 = 4.2 mph at 8% Grade Stage 5 = 5.0 mph at 10% Grade Stage 6 = 5.5 mph at 12% Grade Stage 7 = 6.0 mph at 14% Grade Stage 8 = 6.5 mph at 15% Grade Stage 9 = 7.0 mph at 15% Grade. The test will end when subjects reach exhaustion. 5\. 1, 2, and 4 hrs following ingestion, HR, BP, and EKG will be recorded.

Sponsors & Collaborators

• Duquesne University

  lead OTHER

Principal Investigators

• David Delmonico, Ph.D. · Institutional Review Board, Chair, Duquesne University

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

39 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-01-01

Primary Completion

2022-12-31

Completion

2023-03-31

Countries

• United States

Study Locations