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Impact of Energy Drinks on Cardiovascular Endpoints

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ClinicalTrials.gov Identifier: NCT01329679
Recruitment Status : Terminated (Unable to recruit enough subjects)
First Posted : April 6, 2011
Results First Posted : January 10, 2017
Last Update Posted : January 10, 2017
Sponsor:
Information provided by (Responsible Party):
Sachin Shah, David Grant U.S. Air Force Medical Center

Brief Summary:

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 or disease Intervention/treatment
Healthy Volunteers Dietary Supplement: 5 Hour Energy Drug: Placebo

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : April 2011
Primary Completion Date : July 2013
Study Completion Date : July 2013

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 :
  1. 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)

  2. Max Heart Rate After a Single Shot and After Chronic Consumption [ Time Frame: At baseline and 7 days post energy drink and placebo consumption ]
  3. Max PR-interval After a Single Shot and After Chronic Consumption [ Time Frame: At baseline and 7 days post energy drink and placebo consumption ]
  4. Max QRS Duration After a Single Shot and After Chronic Consumption [ Time Frame: At baseline and 7 days post energy drink and placebo consumption ]
  5. 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 ]
  6. 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 ]


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01329679


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

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
First Posted: April 6, 2011    Key Record Dates
Results First Posted: January 10, 2017
Last Update Posted: January 10, 2017
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No