Date of Award

2020

Document Type

Thesis

Degree Name

Master of Science (M.S.)

Department

Pharmaceutical and Chemical Sciences

First Advisor

William A. Kehoe

First Committee Member

Sachin A. Shah

Second Committee Member

Linda L. Nolan

Third Committee Member

John C. Livesey

Abstract

Background: Since its introduction in the early 2000s, energy drinks have become increasingly popular among an extensive range of consumers, including adolescents and young adults. Currently, the United States Food and Drug Administration (FDA) does not regulate the formulation of energy drinks, which may vary widely in the amounts of caffeine and sugar, as well as various types of supplements. Recent reports of severe and fatal adverse effects related to energy drinks have led to growing concerns on the safety of energy drink consumption.

Objective: This study aimed to investigate the effects of chronic daily consumption of energy drinks on cardiometabolic endpoints, including blood pressure, ECG parameters, blood glucose, lipid parameters, weight, body mass index, and body fat consumption in a healthy adult population.

Methods: The study was an unblinded, non-randomized, proof-of-concept, prospective study that evaluated the effects of chronic consumption of energy drinks in a healthy, adult population. Each participant consumed two 16 oz. cans of a commercially available ED daily in two divided doses for 28 days. Investigators met with the participants on days 0, 7, 14, 21, and 28 of the study. Participants were required to complete a standardized log of consumption, which include date and time of consumption, as well an estimate of additional caffeine intake. The following measurements were taken for each participant over the 28 days: blood pressure (BP), electrocardiogram (ECG), fasting blood glucose (FBG), fasting lipid panel (FLP), weight, BMI, body fat composition, and serum creatinine. Adverse side effects related to energy drink consumption were also recorded. Wilcoxan signed-rank tests were used to compare and detect statistical difference between endpoints for baseline and maximum post-dose systolic BP, QTc, FBG, FLP, weight, BMI, body fat, and serum creatinine values.

Results: Of the 14 total participants that were enrolled in the study, 12 participants completed the full study protocol for 28 days. Maximum measurements in peripheral systolic blood pressure (pSBP), peripheral diastolic blood pressure (pDBP), central systolic blood pressure (cSBP), central diastolic blood pressure (cDBP), and heart rate (HR) were found to be statistically significantly higher than baseline measurements (all P < 0.05). The maximum change from baseline to maximum pSBP, pDBP, cSBP, and cDBP were 9±7 mmHg, 5±4 mmHg, 7±6 mmHg, 5±4 mmHg, respectively. Maximum QTcB and QTcF intervals were also statistically higher than baseline (both P = 0.001). The maximum change from baseline in QTcB and QTcF interval were 19±13 ms and 15±10 ms, respectively. Both QTcB and QTcF intervals on days 7, 14, 21, and 28 were all found to be significantly higher than baseline (all P

Results: Of the 14 total participants that were enrolled in the study, 12 participants completed the full study protocol for 28 days. Maximum measurements in peripheral systolic blood pressure (pSBP), peripheral diastolic blood pressure (pDBP), central systolic blood pressure (cSBP), central diastolic blood pressure (cDBP), and heart rate (HR) were found to be statistically significantly higher than baseline measurements (all P < 0.05). The maximum change from baseline to maximum pSBP, pDBP, cSBP, and cDBP were 9±7 mmHg, 5±4 mmHg, 7±6 mmHg, 5±4 mmHg, respectively. Maximum QTcB and QTcF intervals were also statistically higher than baseline (both P = 0.001). The maximum change from baseline in QTcB and QTcF interval were 19±13 ms and 15±10 ms, respectively. Both QTcB and QTcF intervals on days 7, 14, 21, and 28 were all found to be significantly higher than baseline (all P

Pages

54

Available for download on Saturday, April 30, 2022

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