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Impact of Energy Drinks on Cardiovascular Endpoints

This study has been terminated.
(Unable to recruit enough subjects)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01329679
First Posted: April 6, 2011
Last Update Posted: January 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sachin Shah, David Grant U.S. Air Force Medical Center
April 4, 2011
April 6, 2011
August 29, 2016
January 10, 2017
January 10, 2017
April 2011
July 2013   (Final data collection date for primary outcome measure)
Change in Office Systolic Blood Pressure [ Time Frame: At baseline and 7 days post energy drink and placebo consumption ]
SBP = Systolic Blood Pressure measured at baseline (after a single energy shot or placebo consumption) and after chronic consumption for 7 days.
Change in Office Systolic Blood Pressure [ Time Frame: At baseline and 7 days post energy drink and placebo consumption ]
Complete list of historical versions of study NCT01329679 on ClinicalTrials.gov Archive Site
  • Office DBP After a Single Energy Shot and After Chronic Consumption [ Time Frame: At baseline and 7 days post energy drink and placebo consumption ]
    Office diastolic blood pressure (DBP)
  • Max Heart Rate After a Single Shot and After Chronic Consumption [ Time Frame: At baseline and 7 days post energy drink and placebo consumption ]
  • Max PR-interval After a Single Shot and After Chronic Consumption [ Time Frame: At baseline and 7 days post energy drink and placebo consumption ]
  • Max QRS Duration After a Single Shot and After Chronic Consumption [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: At baseline and 7 days post energy drink and placebo consumption ]
Office diastolic blood pressure, ambulatory blood pressure and electrocardiographic changes [ Time Frame: At baseline and 7 days post energy drink and placebo consumption ]
Not Provided
Not Provided
 
Impact of Energy Drinks on Cardiovascular Endpoints
Evaluation of 5-Hour ENERGY® Drink on the Blood Pressure and Electrocardiographic Parameters on Young Healthy Volunteers: 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: 5 Hour Energy or Placebo

Primary outcome: Change in office systolic blood pressure

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Healthy Volunteers
  • Dietary Supplement: 5 Hour Energy
    5 Hour Energy, 2oz twice daily for 7 days
  • Drug: Placebo
    Water, lime juice and cherry flavoring
  • Experimental: 5 Hour Energy
    Intervention: Dietary Supplement: 5 Hour Energy
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
29
July 2013
July 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy volunteers (active-duty) between ages 18-40 years

Exclusion Criteria:

  • No other co-morbid conditions
  • No active prescription or OTC drug use
  • Not pregnant or planning to become pregnant during study participation
Sexes Eligible for Study: All
18 Years to 40 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT01329679
FWH20110111H
No
Not Provided
Plan to Share IPD: No
Sachin Shah, David Grant U.S. Air Force Medical Center
David Grant U.S. Air Force Medical Center
Not Provided
Principal Investigator: Shah Sachin, Pharm.D. David Grant Medical Center
David Grant U.S. Air Force Medical Center
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP