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Cardiovascular Effects of Energy Drinks in Healthy Adults

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ClinicalTrials.gov Identifier: NCT01940822
Recruitment Status : Recruiting
First Posted : September 12, 2013
Last Update Posted : December 13, 2017
Sponsor:
Information provided by (Responsible Party):
Virend Somers, Mayo Clinic

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Energy Drinks Hemodynamics Cardiovascular System Other: Energy Drink Other: Placebo Drink Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Cardiovascular Effects of Energy Drinks in Healthy Adults
Study Start Date : July 2013
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

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



Primary Outcome Measures :
  1. Change in blood pressure [ Time Frame: Baseline, 30 minutes after consumption ]

Secondary Outcome Measures :
  1. Change in heart rate [ Time Frame: Baseline, 30 minutes after consumption ]
  2. Change in Plasma Norepinephrine [ Time Frame: Baseline, 30 minutes after consumption ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01940822


Contacts
Contact: Anna Svatikova, M.D., Ph.D. Svatikova.Anna@mayo.edu

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Anna Svatikova, MD, PhD       svatikova.anna@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Virend K Somers, MD, PhD Mayo Clinic

Publications of Results:
Responsible Party: Virend Somers, Professor of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01940822     History of Changes
Other Study ID Numbers: 13-001918
First Posted: September 12, 2013    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No