Impact of Energy Drinks on Cardiovascular Endpoints

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Sachin Shah, David Grant U.S. Air Force Medical Center
ClinicalTrials.gov Identifier:
NCT01329679
First received: April 4, 2011
Last updated: July 30, 2013
Last verified: July 2013
  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 ]

Enrollment: 29
Study Start Date: April 2011
Study Completion Date: July 2013
Primary Completion Date: July 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

Sponsors and Collaborators
David Grant U.S. Air Force Medical Center
Investigators
Principal Investigator: Shah Sachin, Pharm.D. David Grant Medical Center
  More Information

No publications provided

Responsible Party: Sachin Shah, Assistant Professor of Pharmacy Practice, David Grant U.S. Air Force Medical Center
ClinicalTrials.gov Identifier: NCT01329679     History of Changes
Other Study ID Numbers: FWH20110111H
Study First Received: April 4, 2011
Last Updated: July 30, 2013
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on April 16, 2014