Impact of Energy Drinks on Cardiovascular Endpoints

Effects of Single and Multiple Energy Shots on Blood Pressure and Electrocardiographic Parameters: A Randomized, Double Blind, Crossover, Placebo-controlled Trial

Objective: To assess the cardiac effects of a an energy drink on blood pressure and heart rhythm in healthy subjects.

Study design: Double blind, placebo controlled, cross-over

Study population: Healthy human volunteers (active-duty) between age 18 to 40 years with no other medical conditions.

Intervention: Energy drink or Placebo

Primary outcome: Change in office systolic blood pressure

Study Overview

• Status: Terminated
• Conditions: Healthy Volunteers
• Intervention / Treatment: Dietary supplement: Energy Drink; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy volunteers between ages 18-40 years
• ONLY "as needed" use of ibuprofen or acetamenophen
• Active duty military
• DoD beneficiary or Civilian Government Employees

Exclusion Criteria:

• No other co-morbid conditions
• No active prescription or OTC drug use
• Not pregnant or planning to become pregnant during study participation

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Energy Drink; Energy drink, 2 oz twice daily for 7 days	Dietary supplement: Energy Drink; Energy drink, 2oz twice daily for 7 days
Placebo Comparator: Placebo; Water, lime juice and cherry flavoring, 2 oz twice daily for 7 days	Other: Placebo; Water, lime juice and cherry flavoring; Other Names: Water, lime juice and cherry flavoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Office Systolic Blood Pressure	SBP = Systolic Blood Pressure measured at baseline (after a single energy shot or placebo consumption) and after chronic consumption for 7 days.	At baseline and 7 days post energy drink and placebo consumption

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Office DBP After a Single Energy Shot and After Chronic Consumption	DBP = Diastolic Blood Pressure measured at baseline (after a single energy shot or placebo consumption) and after chronic consumption for 7 days.	At baseline and 7 days post energy drink and placebo consumption
Max Heart Rate After a Single Shot and After Chronic Consumption	Maximum heart rate measured at baseline (after a single energy shot or placebo consumption) and after chronic consumption for 7 days	At baseline and 7 days post energy drink and placebo consumption
Max PR-interval After a Single Shot and After Chronic Consumption	Maximum PR-interval measured at baseline (after a single energy shot or placebo consumption) and after chronic consumption for 7 days	At baseline and 7 days post energy drink and placebo consumption
Max QRS Duration After a Single Shot and After Chronic Consumption	Max QRS duration measured at baseline (after a single energy shot or placebo consumption) and after chronic consumption for 7 days	At baseline and 7 days post energy drink and placebo consumption
Max QT Interval After a Single Energy Shot or Placebo Consumption After Day 1 and After Chronic Consumption After Day 7	Max QT interval measured at baseline (after a single energy shot or placebo consumption) and after chronic consumption for 7 days	At baseline and 7 days post energy drink and placebo consumption
Max QTc Interval After a Single Energy Shot or Placebo Consumption After Day 1 and After Chronic Consumption After Day 7	Max QTc interval measured at baseline (after a single energy shot or placebo consumption) and after chronic consumption for 7 days	At baseline and 7 days post energy drink and placebo consumption

Collaborators and Investigators

• Sponsor: David Grant U.S. Air Force Medical Center
• Investigators: Principal Investigator: Shah Sachin, Pharm.D., David Grant Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2011
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: April 4, 2011
• First Submitted That Met QC Criteria: April 5, 2011
• First Posted (Estimate): April 6, 2011

Study Record Updates

• Last Update Posted (Actual): September 9, 2020
• Last Update Submitted That Met QC Criteria: August 24, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: FWH20110111H

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No