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Impact of Energy Drinks on Cardiovascular Endpoints

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by David Grant U.S. Air Force Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
David Grant U.S. Air Force Medical Center
ClinicalTrials.gov Identifier:
NCT01329679
First received: April 4, 2011
Last updated: October 27, 2011
Last verified: April 2011
History of Changes

April 4, 2011
October 27, 2011
April 2011
February 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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01329679 on ClinicalTrials.gov Archive Site
Office diastolic blood pressure, ambulatory blood pressure and electrocardiographic changes [ Time Frame: At baseline and 7 days post energy drink and placebo consumption ] [ Designated as safety issue: Yes ]
Same as current
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
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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.
 
Recruiting
40
February 2013
February 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
Both
18 Years to 40 Years
Yes
Contact: Sachin A Shah, Pharm.D. 707 423 3277 sachin.shah.1.ctr.in@us.af.mil
United States
 
NCT01329679
FWH20110111H
No
MICHAEL LEE, Lt Col, USAF, BSC/SGQP, David Grant Medical Center
David Grant U.S. Air Force Medical Center
Not Provided
Principal Investigator: Michael Lee, Pharm.D. David Grant Medical Center
David Grant U.S. Air Force Medical Center
April 2011

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