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

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StatusRekrutacyjny
Sponsorzy
Duquesne University

Słowa kluczowe

Abstrakcyjny

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.

Opis

Title: The Effect of Energy Drink Ingredients on Cardiovascular Function

1. Statement of the research question

Does the caffeine in energy drinks interact with other ingredients to affect cardiovascular function, including QTc interval of the EKG, heart rate and blood pressure 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 include cardiac arrhythmias such as ventricular fibrillation, atrial fibrillation, and cardiac arrest. A few small clinical studies have reported that energy drinks can increase systolic and diastolic blood pressure and change electrical activity in the heart as measured by an electrocardiogram (EKG). The intent of the proposed study is to determine whether caffeine or the combination of caffeine with taurine and L-carnitine can alter heart rate, blood pressure and the QTc interval of the EKG. Caffeine stimulates cardiovascular function primarily through antagonism of adenosine receptors. Taurine is a modulator of intracellular calcium ion concentrations which can affect the strength cardiac contraction. Carnitine facilitates fatty acid transport into the mitochondria, thereby increasing the production of adenosine triphosphate, the energy source of cells. 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.

Daktyle

Ostatnia weryfikacja: 04/30/2020
Pierwsze przesłane: 10/30/2019
Szacowana liczba przesłanych rejestracji: 10/30/2019
Wysłany pierwszy: 11/03/2019
Ostatnia aktualizacja przesłana: 05/26/2020
Ostatnia opublikowana aktualizacja: 05/28/2020
Rzeczywista data rozpoczęcia badania: 12/31/2019
Szacowana data zakończenia podstawowej działalności: 11/30/2020
Szacowana data zakończenia badania: 02/28/2021

Stan lub choroba

Cardiac Arrhythmia
Blood Pressure

Interwencja / leczenie

Dietary Supplement: Energy Drink Ingredients and Exercise

Faza

-

Grupy ramion

RamięInterwencja / leczenie
Experimental: Changes in BP, HR and EKG with Test Solution A and Exercise
Subject baseline HR, BP, EKG recorded. Subject will ingest sucrose (150g): 30 min later, subject will exercise on a treadmill 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
Subject baseline HR, BP, ECG recorded. Subject will ingest sucrose (150g); caffeine (400 mg) 30 min later, subject will exercise on a treadmill 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
Subject baseline HR, BP, ECG recorded. Subject will ingest sucrose (150g); caffeine (400 mg); taurine (4,000 mg); carnitine (400 mg) 30 min later, subject will exercise on a treadmill
Experimental: Changes in BP, HR and EKG with Test Solution C
Subject baseline HR, BP, ECG recorded. Subject will ingest sucrose (150g); caffeine (400 mg); taurine (4,000 mg); carnitine (400 mg)

Kryteria kwalifikacji

Wiek kwalifikujący się do nauki 18 Years Do 18 Years
Płeć kwalifikująca się do naukiAll
Przyjmuje zdrowych wolontariuszytak
Kryteria

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

Wynik

Podstawowe miary wyników

1. Change in QTc interval of EKG [0, 1, 2, 4, hours post-dose]

Lengthening or shortening of the corrected QT interval (QTc) of the subject EKG at 1, 2, and 4 hours post treatment will be compared to pre-treatment measurements. The QTc will be calculated utilizing Bezett's formula.

Miary wyników wtórnych

1. Change in Heart Rate [0, 1, 2, 4, hours post-dose]

Increase or decrease in heart rate at 1, 2, and 4 hours post treatment compared to pre-treatment. Measurements of heart rate will be taken utilizing an automated sphygmomanometer

2. Change in Systolic and Diastolic Blood Pressure [0, 1, 2, 4, hours post-dose]

Increase or decrease in systolic and diastolic blood pressure at 1, 2, and 4 hours post treatment compared to pre-treatment. Measurements of heart rate will be taken utilizing an automated sphygmomanometer.

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