Recruiting

Energy Drink Ingredients

Sponsor:

Duquesne University

Code:

NCT04149717

Conditions

Cardiac Arrhythmia

Blood Pressure

Eligibility Criteria

Sex: All

Age: 18 - 39

Healthy Volunteers: Accepted

Interventions

Energy Drink Ingredients and Exercise

Study Details

Brief 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

Study ID

NCT04149717

Start date

Jan 1, 2020

Status verified date

May, 2020

Completion date

Mar, 2023

Anticipated

Primary completion date

Dec, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 39

Healthy Volunteers: Accepted

Inclusion Criteria:

1. No preexisting medical conditions (including pregnancy)
2. Subjects must be capable of exercising on a treadmill (Vigorous activity: more than 7 kcal/min; https://www.cdc.gov/nccdphp/dnpa/physical/pdf/PA_Intensity_table_2_1.pdf)
3. BMI within normal range (18.5 - 24.9 kg/m2)
4. Average daily caffeine intake between 1 and 5 caffeinated beverages

Exclusion Criteria:

1. Age below 18 or greater than 39 years
2. Unable to provide legal consent to participate in the study
3. Preexisting medical conditions including but not limited to: pregnancy, cardiovascular disease, endocrine disorders, psychiatric or neurological disorders, musculo-skeletal disorders, immune disorders, respiratory disorders, dermatological disorders, infections, blindness, hearing disabilities
4. BMI less than 18.5 or greater than 24.9 kg/m25.
5. Current or future students of Drs. Johnson and/or Montepara
6. Incarceration in local, state or federal justice systems

Study Design

Enrollment

35 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Changes in BP, HR and EKG with Test Solution A and Exercise

1. Subject baseline HR, BP, EKG recorded.
2. Subject will ingest sucrose (150g):
3. 30 min later, subject will exercise on a treadmill
4. Subjects will return each week to repeat the above procedures with a different test solution.

experimental: Changes in BP, HR and EKG with Test Solution B and Exercise

1. Subject baseline HR, BP, ECG recorded.
2. Subject will ingest sucrose (150g); caffeine (400 mg)
3. 30 min later, subject will exercise on a treadmill
4. Subjects will return each week to repeat the above procedures with a different test solution.

experimental: Changes in BP, HR and EKG with Test Solution C and Exercise

1. Subject baseline HR, BP, ECG recorded.
2. Subject will ingest sucrose (150g); caffeine (400 mg); taurine (4,000 mg); carnitine (400 mg)
3. 30 min later, subject will exercise on a treadmill

experimental: Changes in BP, HR and EKG with Test Solution C

1. Subject baseline HR, BP, ECG recorded.
2. Subject will ingest sucrose (150g); caffeine (400 mg); taurine (4,000 mg); carnitine (400 mg)

Interventions

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.

Primary outcome measure

  • Change in QTc interval of EKG [ Time Frame: 0, 1, 2, 4, hours post-dose ]

Central Contacts and Locations

Central contacts

David A Johnson, Ph.D.

412-396-5952johnsond@duq.edu

Courtney Montepara, Pharm.D.

412-396-4335monteparac@duq.edu

Locations

Duquesne University

Recruiting

Pittsburgh, Pennsylvania, United States, 15282

Contacts

David A Johnson, Ph.D.

412-396-5952johnsond@duq.edu

Courtney Montepara, Pharm.D.

4123964335monteparac@duq.edu

More Information

Sponsor

Duquesne University

Last update posted

Mar 23, 2021

Last verified

May, 2020

Keywords

  • caffeine
  • taurine
  • carnitine
  • energy drink

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Duquesne University on 2021-03-23.