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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
  Purpose

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


Condition Intervention
Healthy Volunteers
 Dietary Supplement: 5 Hour Energy
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: 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

Further study details as provided by David Grant U.S. Air Force Medical Center:

Primary Outcome Measures:
  • Change in office systolic blood pressure [ Time Frame: At baseline and 7 days post energy drink and placebo consumption ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: April 2011
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 5 Hour Energy Dietary Supplement: 5 Hour Energy
5 Hour Energy, 2oz twice daily for 7 days
Placebo Comparator: Placebo Drug: Placebo
Water, lime juice and cherry flavoring

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01329679

Contacts
Contact: Sachin A Shah, Pharm.D. 707 423 3277 sachin.shah.1.ctr.in@us.af.mil

Locations
United States, California
David Grant Medical Center Recruiting
Travis AFB, California, United States, 94535
Contact: Sachin A Shah, Pharm.D.     707-423-3277        
Sponsors and Collaborators
David Grant U.S. Air Force Medical Center
Investigators
Principal Investigator: Michael Lee, Pharm.D. David Grant Medical Center
  More Information

No publications provided

Responsible Party: MICHAEL LEE, Lt Col, USAF, BSC/SGQP, David Grant Medical Center
ClinicalTrials.gov Identifier: NCT01329679     History of Changes
Other Study ID Numbers: FWH20110111H
Study First Received: April 4, 2011
Last Updated: October 27, 2011
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on May 16, 2013