Cardiovascular Effects of Energy Drinks in Healthy Adults

This study is being done to look at the cardiovascular response, if any, to intake of commercially available energy drink. We hypothesize that energy drink consumption compared to a control drink in healthy adults alters the cardiovascular hemodynamic system.The focus of this study is to elucidate the physiological/cardiovascular response to an energy drink consumption as compared to a control drink both at rest and during stressful conditions in healthy adults.

Study Overview

• Status: Completed
• Conditions: Cardiovascular System; Hemodynamics; Energy Drinks
• Intervention / Treatment: Other: Energy Drink; Other: Placebo Drink

Detailed Description

The study will collect data to determine the hemodynamic changes (magnitude of heart rate and blood pressure response) in healthy adults after consumption of an energy drink and compare these responses to those after a control drink. Study will be performed at a hospital Clinical Research Unit on two separate days; minimum 24 hours and maximum 1 month apart. Participants will be fasting 4 hours prior to the study and will be asked to abstain from caffeine and alcohol for at least 24 hours prior to initiation of this study. Baseline measurements will be obtained during and after 10 minutes of rest. After the end of baseline recordings, the subjects will be given up to 500 ml (1 can, approximately 16 fluid ounces) of caffeinated energy drink or a control drink, based on randomization. They will have 30 minutes to drink it. The second set of measurements will be obtained after an energy drink or control drink intake, using exactly the same protocol as at baseline. The second study visit, participant will receive the alternate intervention.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults 18 years of age and older
• Healthy subjects without known cardiovascular disease and thyroid disease
• Subjects who are on no medications (except oral contraceptive pill)
• Nonsmokers
• No prior history of caffeine sensitivity or allergy

Exclusion Criteria:

• Subjects with known cardiovascular and/or thyroid disease
• Subjects currently taking medications other than oral contraceptive pill
• Smokers
• Prior history of caffeine sensitivity or allergy
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Energy drink first, then placebo drink; Participants will receive an energy drink at the first study visit, and a placebo drink at the second study visit.	Other: Energy Drink; Other: Placebo Drink
Experimental: Placebo drink first, then energy drink; Participants will receive a placebo drink at the first study visit and an Energy Drink at the second study visit.	Other: Energy Drink; Other: Placebo Drink

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in blood pressure	Baseline, 30 minutes after consumption

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in heart rate	Baseline, 30 minutes after consumption
Change in Plasma Norepinephrine	Baseline, 30 minutes after consumption

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Anna Svatikova, M.D., Ph.D., Mayo Clinic

Publications and helpful links

General Publications

• Svatikova A, Covassin N, Somers KR, Somers KV, Soucek F, Kara T, Bukartyk J. A Randomized Trial of Cardiovascular Responses to Energy Drink Consumption in Healthy Adults. JAMA. 2015 Nov 17;314(19):2079-82. doi: 10.1001/jama.2015.13744. No abstract available.

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): November 30, 2013
• Study Completion (Actual): November 30, 2013

Study Registration Dates

• First Submitted: September 9, 2013
• First Submitted That Met QC Criteria: September 9, 2013
• First Posted (Estimate): September 12, 2013

Study Record Updates

• Last Update Posted (Actual): May 18, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 13-001918

Plan for Individual participant data (IPD)

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