Impact of Energy Drinks on Cardiovascular Endpoints

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01329679
• Other study ID #: FWH20110111H
• Status: Terminated
• Phase: N/A
• Start date: April 2011
• Est. completion date: July 2013

Study information

• Verified date: August 2020
• Source: David Grant U.S. Air Force Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Dietary Supplement:
• Energy Drink
Energy drink, 2oz twice daily for 7 days

Other:
• Placebo
Water, lime juice and cherry flavoring

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
David Grant U.S. Air Force Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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