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Impact of Energy Drinks on Cardiovascular Endpoints

This study has been terminated.
(Unable to recruit enough subjects)
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: November 13, 2016
Last verified: November 2016
  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
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 ]
    SBP = Systolic Blood Pressure measured at baseline (after a single energy shot or placebo consumption) and after chronic consumption for 7 days.


Secondary Outcome Measures:
  • 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 ]

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   (Adult)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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
Results First Received: August 29, 2016
Last Updated: November 13, 2016
Individual Participant Data  
Plan to Share IPD: No

ClinicalTrials.gov processed this record on March 24, 2017